Career Opportunities

How to Apply

When an opportunity in which you are interested becomes available, please submit your resume or CV, cover letter with job code and salary requirements to the address below. All submissions will be evaluated. Interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for one year.

Open Positions

Senior Director, Quality Assurance

 

Job #:  02-232

Job Title:  Senior Director of Quality Assurance

Location:  Waltham, MA

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Senior Director of Quality Assurance whose responsibilities will encompass all aspects of Quality Assurance, from strategic planning to hands-on implementation.  This person is responsible for the strategy, implementation & leadership of the Quality function at Proficient Life Pharma and is accountable for the execution and administration of the GxP Quality System pertaining to GLP, GMP, GCP and relevant ICH, US, EU and international regulations.

This position will report to the VP Regulatory Affairs & Quality Assurance, and be located in the Waltham, Massachusetts office.

Key Responsibilities:

  • Ensure overall Quality & Compliance oversight for manufacturing, nonclinical, clinical and commercial supply chain activities
  • Establish & maintain phase-appropriate Quality Management Systems
  • Ensure appropriate Quality oversight of external vendors (CMOs, CROs, etc.)
  • Ensure oversight of Proficient Life Pharma’s internal Quality Systems training program.
  • Plan & oversee day-to-day activities of the Quality function including management of existing experienced quality staff and consultants/auditors, to ensure project & business needs are met
  • Establish Change Control Review Board and others as needed
  • Evaluation of external vendors to include onsite auditing
  • Manage the APQR and GMP Management Review Committee
  • Work with the regulatory, manufacturing, clinical and nonclinical functions to further build out the Quality function to support the expanding Proficient Life Pharma organization
  • Develop and oversee appropriate Quality metrics and report on the state of Proficient Life Pharma’s compliance to senior management
  • Lead preparations for and management of any Regulatory Agency inspections, including PAI inspection readiness activities
  • Provide leadership & mentorship to the Quality team
  • Ability to travel approximately 10-15% of the time

 Required Qualifications:

  •  BS in Chemistry, Pharmacy, Biology or a related pharmaceutical science.
  • 15+ years of progressive managerial experience within the Quality function of a pharmaceutical company. Experience leading a Quality function is required.
  • Experience working in small biopharmaceutical company and/or experience working within a virtual manufacturing company utilizing multiple contract manufacturing organizations is preferred
  • Recent experience (within the last 5 years) supporting initial marketing authorizations is required
  • Extensive knowledge and experience in GxP and QA principles, practices & industry standards
  • Experience with oral small molecule development programs, from early-stage through to commercial
  • A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs
  • Experience with using risk-based principles & decision making to ensure compliance at all stages of development
  • Proven track-record of leadership & building relationships with both internal & external customers
  • Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Associate Director, Quality Control

Job #: 02-231

Job Title:  Associate Director, Quality Control

Location:  Waltham, MA

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking an Associate Director, Quality Control, who will have responsibility for leading and managing the pharmaceutical GMP quality control activities associated with development and commercialization of the company’s small-molecule assets. Operating within a virtual (100% outsourced) business model, the incumbent will be responsible for site implementation of IPC and QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components, review/approval of protocols, methods, reports, batch records and related GMP source documents, oversight of stability operations and reference standard management, and transfer/site implementation of analytical methods to support future supply chain expansion.

The successful candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.

This position will report to the Senior Director, Analytical Development and MS&T and be located in the Waltham, MA office.

Key Responsibilities:

  • Manage/oversee qualification and site implementation of IPC and QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.
  • Manage/oversee analytical method transfers and site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives.
  • Manage/oversee stability operations and reference standard program.
  • Participate in the selection of analytical CROs/CDMOs based upon core capabilities and regulatory compliance.
  • Review/approve controlled GMP documents, e.g., analytical methods and associated validation protocols, specifications, change controls, LIRs, etc.
  • Review/approve development reports for data integrity and regulatory compliance; review/approve CMC content incorporated into Module 3 sections of CTD regulatory submissions for translational accuracy.
  • Support cGMP audits of CDMO laboratories.
  • Author and/or review standard operating procedures (SOPs) relating to analytical development and quality control.
  • Maintain effective communication with CDMOs and deliver QC objectives in accordance with project timelines and budgets.

Required Qualifications:

  • S./M.S. degree in analytical chemistry or related life sciences discipline with at least 10 years of quality control experience in pharmaceutical product development.
  • In-depth understanding of CMC regulatory requirements for product registration and cGMP compliance requirements for pharmaceutical quality control laboratories.
  • Strong vendor/supplier management and cross-functional collaboration skills.
  • Ability to work successfully in a team/matrix environment and independently, as required.
  • Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
  • Ability to convey both written and verbal information effectively and efficiently.
  • Ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail.
  • Ability to travel (15%) to CRO/CDMO domestic and international sites.

 Preferred Qualifications:

  • Experience in developing and commercializing drugs for oncology and/or orphan diseases is desirable.
  • Significant work experience in a virtual (100% outsourced) biopharmaceutical development business model is strongly preferred.

 

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Director/Senior Director, CMC Program Management

Job #:02-230

Job Title:Director/Senior Director, CMC Program Management

Location: Waltham, MA

Role Summary:
Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immunotargeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Director/Senior Director, CMC Program Management, who will have responsibility for leading and managing cross-functional CMC teams engaged in the development and commercialization of the company’s small-molecule assets. Operating within a virtual (100% outsourced) business model, the incumbent will be accountable for team strategy and deliverables, ensuring operational excellence with respect to timelines, budgets, and attainment of technical, regulatory and business goals/milestones. The successful candidate will also play a central role in the development of strong and enduring relationships with CDMO business partners, and support strategic partnerships relating to potential in-licensing and/or out-licensing opportunities and external collaboration agreements.

The successful candidate will have significant experience in CMC development and commercialization of small molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with product registration and commercial launch. S/he will possess strong leadership, management and communication skills, ensuring that team members understand and respect program goals, objectives, priorities, and timelines.

This position will report to the Chief Technical Officer and be located in the Waltham, MA office.

Key Responsibilities:

  • Develop and maintain fully integrated CMC project plans, incorporating activities, internal/external resource requirements and key interdependencies, that deliver tangible results against program and corporate goals.
  • Establish and implement operational mechanisms to facilitate effective and timely cross-functional communication and decision making, and successful execution of program plans.
  • Lead data-driven decision-making processes to enable timely and objective recommendations for continuation, acceleration, reprioritization, redesign or termination of program workstreams.
  • Identify, define, prioritize and communicate risks to successful program execution; develop and monitor risk mitigation and contingency plans.
  • Develop and manage program budgets, AOP/LRP forecasts and quarterly accruals.
  • Communicate progress at all levels and escalate critical issues; provide regular status reports to executive leadership and functional area management.
  • Support development and implementation of PM systems and best practices to ensure consistency and operational effectiveness within and across programs.
  • Develop and maintain strong relationships with CRO/CDMO business partners and participate in quarterly Joint Steering Committees across the supply chain.
  • Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address CMC and supply chain risk.
  • Serve as an integral member of the Technical Operations Leadership Team, ensuring cross-functional alignment of program strategy.
  • Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities, as required.

Required Qualifications

  • B.S./M.S. degree in an engineering or life sciences discipline with at least 10 years of experience in small-molecule CMC development and commercialization
  • Track record of success in leading and managing cross-functional CMC teams, ideally within a 100% outsourced environment.
  • Competency in developing, implementing and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
  • Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in a crossfunctional team environment, fostering open communication, mutual understanding and cooperation.
  • Pragmatic, solution-oriented thinker who possesses a “can do” and “whatever it takes” attitude, coupled with excellent organizational and communication skills.
  • Strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view.
  • Track record of collaboration, stakeholder relationship management, and influencing key decision makers.
  • In-depth knowledge of the drug development process and ICH requirements for NDA and MAA registration. Prior experience working with regulatory authorities.
  • Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution.
  • Ability to articulate complex issues and ideas with clarity to enable understanding and timely decision making.
  • Ability to travel (10-15%) to CRO/CDMO domestic and international sites.
  • Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project).

Preferred Qualifications:

  • Experience in developing and commercializing drugs for oncology and/or orphan diseases is strongly preferred.
  • A Ph.D. degree in an engineering or life sciences discipline or M.B.A. in operations management is highly desired.
  • Track record of authoring and defending Module 3 CTD content through regulatory approval and commercialization is advantageous.Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.
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Senior Director Analytical Development and MS&T

Job #:  02-227;

Job Title:  Senior Director, Analytical Development and MS&T

Location:  Waltham, MA

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Senior Director, Analytical Development and MS&T, who will have overall responsibility for leading and managing late-stage CMC development and commercial MS&T activities related to analytical characterization of products/processes and the development, qualification, transfer and validation of analytical methods for QC release and stability testing of small-molecule drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components. Operating within a virtual (100% outsourced) business model, the incumbent will have accountability for analytical CRO/CDMO selection and oversight, and the development of strong and enduring business partnerships. The successful candidate will also assume a key leadership role in the development, review and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs, and will support strategic partnerships relating to potential in-licensing and/or out-licensing opportunities and external collaboration agreements.

This position will report to the Chief Technical Officer and be located in the Waltham, MA office.

Key Responsibilities:

  • Lead and manage small-molecule product/process characterization activities and the development, validation and site implementation of IPC and QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.
  • Lead and manage analytical method transfers and site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives.
  • Oversee stability operations and reference standard management.
  • Lead the selection of analytical CROs/CDMOs based upon core capabilities, capacity and track record of regulatory compliance; establish KPIs to monitor site technical, quality and business performance.
  • Develop and maintain strong relationships with CRO/CDMO business partners and participate in quarterly Joint Steering Committees across the supply chain.
  • Review/approve technical reports, controlled GMP documents (e.g., analytical methods and associated validation protocols, specifications, change controls, LIRs, SOPs, etc.) and CMC content for Module 3 CTDs.
  • Develop and manage scope, milestones, interdependencies, budgets and timelines associated with analytical program deliverables.
  • Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address CMC and supply chain risk.
  • Serve as an integral member of the Technical Operations Leadership Team, ensuring cross-functional alignment of analytical program deliverables with overall program strategy.
  • Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities.

Required Qualifications:

  • A B.S./M.S. degree in analytical chemistry or related life sciences discipline with at least 15 years of experience in small-molecule pharmaceutical product development and commercialization.
  • Track record of success in leading and managing small-molecule analytical development and MS&T programs in a 100% outsourced environment.
  • Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills.
  • Competency in developing, implementing and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
  • Strong decision-making skills and ability to influence internal and external stakeholders.
  • Thorough knowledge of the drug development process and ICH requirements for NDA and MAA registration. Extensive experience in working with regulatory authorities. Track record of authoring and defending Module 3 CTD content through regulatory approval and commercialization.
  • Ability to articulate complex issues and ideas with clarity to enable understanding and decision making.
  • Ability to work successfully in a team/matrix environment and independently, as required.
  • Ability to influence cross-functionally to enable improvements and enhance performance across CMC development, MS&T and supply chain functions.
  • Ability to travel (20%) to CRO/CDMO domestic and international sites.

Preferred Qualifications:

  • Experience in developing and commercializing drugs for oncology and/or orphan diseases is strongly preferred.
  • A Ph.D. degree in analytical chemistry or M.B.A. in operations management is highly desired.

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Associate Director of Biostatistics

Job #:  02-204

Job Title:  Associate Director of Biostatistics

Location: Waltham, MA

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.,

We are seeking an Associate Director to the Biostatistics group

This position will report to the Head of Biostatistics and Data Management and be located in the Waltham, MA office.

Key Responsibilities:

  • Serve as a lead statistician and manage statistical efforts for multiple clinical studies and/or a clinical program
  • Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
  • Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
  • Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
  • Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents
  • Work with statistical programmers or CROs to generate tables, figures and listings
  • Perform ad hoc and exploratory statistical analyses as needed
  • Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
  • Support regulatory submissions as needed; provide response to regulatory requests independently
  • Support the preparation of publications, including manuscripts, posters and oral presentations
  • Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs

 Required Qualifications:

  • PhD in statistics or a related field with at least 6 years of relevant clinical trial experience or MS in statistics or equivalent with at least 8 years of relevant clinical trial experience
  • Knowledge of statistical methods for clinical trials
  • In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
  • Proficient in statistical programming (SAS is required)
  • Experience with trial design software (e.g., EAST or nQuery)
  • Good communication skills and ability to work with cross-functional study teams
  • Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
  • Good analytical and problem-solving skills
  • Positive and collaborative attitude

Preferred Qualifications:

  • Experience with NDAs/BLAs, MAAs and other regulatory submissions is a plus
  • Proficient in running simulations using either SAS or R

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Director, Preclinical Sciences

Job #:  04-204

Job Title:   Director, Preclinical Sciences

Job Location:  Lawrence, KS

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Director, Preclinical Services to interface with other functional groups within the company, including Research, CMC/Manufacturing, and Regulatory Affairs.

This position will report to the Chief Scientific Officer in the Lawrence, KS office.

 Key Responsibilities:

  • Collaborate with research project leaders, CMC development, and Regulatory to develop project-specific strategies to generate appropriate data to support development candidate nomination and IND filing of new small molecule drug entities
  • Oversee the design and management of pre-clinical studies (GLP and non-GLP) for inclusion in IND submissions, including ADME/DMPK, biodistribution, safety pharmacology and toxicology studies
  • Oversee the selection and management of consultants and contract research organizations (CROs) to support pre-clinical development programs
  • Manage projects conducted by CROs with efficient governance including contract execution, authorization of study amendments, schedule and budget variance management, progress reporting to stakeholders, review of data and draft study reports, completion of contract milestones, study close-out and alignment of preclinical development efforts with corporate drug development efforts and priorities
  • Write and edit pre-clinical study Research Reports
  • Oversee drafting of the relevant sections and individual reports to support regulatory filing including pre-IND, IND, IND annual updates, IB, clinical lab manuals, as well as relevant sections to support NDA filings.  Oversee drafting and submission of relevant sections to support international filings (EMA, etc)
  • Participate in discussions with FDA to obtain feedback on pre-clinical development programs
  • Contribute to clinical development plans
  • Ensure compliance with global pre-clinical studies regulatory guidelines
  • Ensures completion of preclinical studies to support Company timelines and goals

 Basic Qualifications:

  • PhD or DVM and post-doctoral experience in Pharmacology, Drug Metabolism, Toxicology or Pathology and knowledge of biochemistry, cell biology, systems biology, physiology, and pharmacokinetics.
  • Solid understanding of the drug discovery and development process based on at least 7-10 years of relevant experience in the biotech/pharmaceutical industry
  • Demonstrable contributions to regulatory filings and working knowledge of GLP, GCP and ICH regulations
  • Experience with the design and execution of in vitro/in vivo experiments to determine the effects of therapeutics on biological systems, with line of sight to human safety risk understanding.
  • Hands-on experience with in vitro toxicology, pharmacology and/or molecular biology experimentation to investigate molecular mechanisms of drug action.
  • Strong leadership competencies and management experience, including selecting CROs and overseeing the relationship.
  • Excellent written and oral communication, presentation and influencing skills. Highly motivated, creative, and innovative, with a flexible, collaborative, team-oriented mindset, who solves problems in a goal-focused fashion and can excel in a fast-paced small company environment
  • A social personality that contributes to an open, positive, collaborative working climate.

 Preferred Qualifications:

  • DABT certification and experience as GLP Study Director is preferred, but not required.
  • Working knowledge of human dose modeling

 

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for health care and/or dependent care.

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Scientist II, Chemistry

Job #:  04-205

Job Title:   Scientist II – Chemistry

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Scientist II, Chemistry to work in the drug discovery team to enhance the company pipeline of drugs to treat human diseases.

This position will report to the Principal Investigator, Chemistry in the Lawrence, KS research facility.

Key Responsibilities:

    • Responsible for design and implementation of synthetic routes to prepare proprietary small molecules for biological testing.
    • Responsible for tracking structure activity relationships and optimizing potency, selectivity and pharmaceutical properties of small molecules for research programs.
    • Responsible for designing new and improved analogs within chemical series.
    • Responsible for adapting synthetic routes to enable more efficient preparation of small molecules on a 10-100 gram scale.
    • Work effectively in a team environment, communicating and planning research with other chemists, molecular biologists, and pharmacologists also working on project.
    • Prepares written reports, experimentals for patents, and other reports as required
    • Values other people and promotes the welfare of the organization and colleagues.
    • Responsible for adhering to corporate policies including safety, FDA compliance and regulatory matters.

Basic Qualifications:

    • M.S. in organic or medicinal chemistry with 3+ years of industrial or B.S. with 5+ years of experience in synthetic organic chemistry / drug discovery.
    • Must possess a good working knowledge of organic synthesis and medicinal chemistry.
    • In-depth knowledge and hands-on experience with a wide range of techniques used in synthesis, purification, and spectroscopic characterization of novel compounds (NMR, LC-MS, HPLC, etc.).
    • Capable of independent design/refinement of synthetic routes considering the needs of the project (e.g., analogue generation, scale-up).
    • Self-aware; will seek input from others on ideas and problem-solving; uses others as a resource.
    • Excellent oral and written communication skills.

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Clinical Project Manager

Job #:  02-223

Job Title:   Clinical Project Manager (CPM)

Location:   Waltham, MA

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.,

We are seeking a Clinical Project Manager to manage clinical trials from initiation to completion through leading internal and external cross-functional disciplines.

This position will report to the VP, Clinical Operations and be located in the Waltham, MA office.

Key Responsibilities:

    • Responsible for the operational implementation of pre-market and post-market clinical trials
    • Develop and manage the project plan and timeline, which may include budget planning
    • Manage escalation of study-related issues and communicate as appropriate with management
    • Select and manage clinical trial vendors such as CROs and external laboratories, and ensure their performance is consistent with Proficient Life Pharma standards
    • Collaborate with clinical supply team on selection and management of an IxR vendor
    • Provide input and coordinate the on-schedule delivery of clinical trial supplies in collaboration with clinical supply team and relevant vendors
    • May perform periodic visits to investigational sites and CROs to assess study progress and compliance
    • Assist and participate in planning and conduct of investigator meetings
    • Oversee the authoring and management of study-related plans and manuals (e.g. project management plan, site monitoring plan, safety management plan, patient recruitment plan, risk management plan, data management plan, study reference manual, regulatory binder, central lab manual, pharmacy manual, statistical analysis plan, etc.)
    • Facilitate the development of study templates such as investigational study budget, informed consent form, and source documents
    • Participate in the development of study protocols by coordinating with the medical writer
    • Participate in authoring the clinical study report as well as the clinical portion of regulatory submissions
    • Participate in review of scientific abstracts and manuscripts
    • Select and manage investigational sites
    • Serve as a resource for vendors, site coordinators, investigators, and other staff members regarding investigational products and protocols
    • Ensure site monitoring is sufficient such that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements and fulfills the study objective
    • May review clinical monitoring reports and related correspondences
    • Provide input on case report form design and EDC system requirements
    • Monitor the status of clinical data collection and query trends

Required Qualifications:

    • Bachelor’s degree in health profession and/or science
    • A minimum of 3 years of relevant clinical operations experience in the pharmaceutical industry and/or CRO
    • Excellent verbal and written communications skills
    • Self-motivated, with strong organizational skills and attention to detail
    • Computer proficiency in MS Office (i.e. Word, Excel, PowerPoint, project)
    • Ability to travel approximately 20%

 Preferred Qualifications:

    • Bachelor’s degree in health profession and/or science
    • A minimum of 3-4 years of relevant clinical operations experience in the pharmaceutical industry (oncology experience)
    • Excellent verbal and written communications skills
    • Self-motivated, with strong organizational skills and attention to detail
    • Computer proficiency in MS Office (i.e. Word, Excel, PowerPoint)
    • Ability to travel approximately 20%

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Manager, Data Management

Job #:  02-221

Job Title:   Manager, Data Management

Location: Waltham, MA

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.,

We are seeking a Manager, Data Management to oversee the quality of outsourced Data Management activities for Oncology Clinical Trials ranging from Phases I to III.

This position will report to the Associate Director of Data Management and be located in the Waltham, MA office.

 Key Responsibilities:

    • Act as the DM subject matter expert for process related questions from CROs, third party vendors and cross functional areas
    • May simultaneously act as lead Data Manager for multiple clinical trials from study start up through database lock
    • Participate in User Acceptance Testing for clinical database, randomization database and ePRO devices
    • Review study documentation to ensure appropriate quality
    • Assist with development of therapeutic area standards for Case Report Forms and Edit Checks
    • Oversee submission of documents to Trial Master File and related QC
    • Ensure study documentation is inspection ready
    • Assist Site Monitors with data entry and query resolution support
    • Review coding and SAE reports on an ongoing basis
    • Work with Medical Affairs team to arrange timelines for delivery of data for posters and presentations
    • Present ongoing study updates to management
    • Manage escalation of study-related issues and communicate as appropriate with management
    • Help select and manage data related clinical trial vendors such as CROs and external laboratories, and ensure their performance is consistent with Proficient Life Pharma standards
    • Oversee quality of both clinical and external data sources
    • Lead cross-functional team in ongoing data review
    • Work closely with biostatistician and programmers to ensure plans for data mapping and analysis are defined and appropriately documented
    • Oversee the authoring and management of study-related documentation (e. g. Data Management Plan, external vendor handling guidelines, Case Report Form Completion Guidelines, Coding Plan, etc.)
    • Assist with the development of Data Management related procedures and work instructions as necessary
    • Monitor the status of clinical data collection and query trends
    • Assess study risks and develop risk mitigation strategy with cross-functional team members

 

Required Qualifications:

    • Bachelor’s degree in health profession and/or science
    • A minimum of 8 years of Data Management experience in the pharmaceutical industry
    • Knowledge of the clinical trial process, ICH GCP, GCDMP and applicable health authority regulations
    • Excellent verbal and written communications skills
    • Proficiency in Electronic Data Capture systems
    • Self-motivated, with strong organizational skills and attention to detail
    • Computer proficiency in MS Office (i.e. Word, Excel, PowerPoint)

Preferred Qualifications:

    • Working knowledge of CDISC and SDTM standards
    • Ability to solve complex problems in a fast-paced environment, providing risk mitigation and solutions
    • Minimum of two years’ experience in Oncology trials
    • Proficiency in IBM Clinical Development

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Senior Manager/Associate Director of Program Management

Job #: 03-201.pdf

Job Title: Senior Manager/Associate Director of Program Management

Location: Waltham, MA

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Senior Manager/Associate Director of Program Management

This position may be filled at the Senior Manager or Associate Director level, based on candidate’s skills/experience, and will report to the Director of Program Management at Proficient Life Pharma’s corporate headquarters in Waltham, MA.

Key Responsibilities:

    • Collects and compiles project information and plans from each functional group (Clinical, CMC, Regulatory, Pharmacology, etc.) as a team member, through internal reporting systems, and direct communications.
    • The successful candidate will apply their project management skills to one or more of three ongoing clinical-stage programs, developing an integrated project plan for each program in collaboration with the functional groups.
    • Provides overall project timeline and interdependencies using critical path planning and other project management methods and tools.
    • Provides risk analysis on project plans, and highlights key risk factors and scenarios for mitigation planning.
    • Sets agendas, conducts meetings, and writes minutes for various meetings, teams, and sub-teams.
    • Trains/coaches/mentors team members and other functional areas in PM systems, procedures, and tools.
    • Analyzes the impact of portfolio and resourcing decisions on projects/programs; develops contingency plans, with assistance from team.
    • Assists management in the selection of action plans that best meet business objectives.
    • Builds and manages overall project budgets through close communication with functional areas and Finance.
    • Manages projects for external development partnerships/alliances, as needed, and works with partner PM, as appropriate.

Basic Qualifications:

    • B.S., M.S., MBA, or Ph.D. in a science or business-related field.
    • Minimum of 5-years project management experience required, including management of large complex programs and cross-functional teams.
    • Proven experience leading teams as a project manager.
    • Knowledge of drug development and generally accepted PM practices, including budgeting, finance, portfolio review, and team management skills.
    • Strong communication, problem-solving, and interpersonal skills. Ability to influence without authority.
    • Proficiency with MS Project or similar project management tools.
    • Team and drug development or project management related experience.
    • Demonstrated leadership skills with broad business orientation.

Preferred Qualifications:

    • M.S. or Ph.D. in a science or business-related field.
    • 5-7 years of experience in areas of drug development/clinical development/safety.
    • Advanced knowledge of project management practices, including budget, finance, portfolio review, and team management skills.
    • PMP certification is a plus.
    • Experience leading drug development projects.
    • Experience managing early stage development projects or projects moving to commercial.
    • Experience with managing oncology projects a plus. General knowledge across multiple therapeutic areas.

Proficient Life Pharma offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for health care and/or dependent.

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Director of Pharmacovigilance

Job #: 02-219

Job Title: Director of Pharmacovigilance

Location: Waltham, MA

Role Summary:

Proficient Life Pharma is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Director of Pharmacovigilance to work with Clinical Development to assist in advancing Clinical Programs.

This position will report directly to VP Clinical Development and Translational Medicine.

Key Responsibilities:

    • Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-­‐‑marketing    sources and from clinical trials, the identification and investigation of safety signals, management of benefit-­‐‑risk profile for assigned compounds and products.
    • Accountable for all PV-­‐‑activities associated with filing and approval of US and EU marketing applications.
    • Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor.  May represent Proficient Life Pharma Drug Safety and    Risk Management at internal and external meetings.
    • The successful candidate will demonstrate the flexibility and capability to function at a high level across various Oncology indications and will be comfortable working    in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle.
    • The individual who assumes this position will interact with multiple levels of management within Proficient Life Pharma, external stakeholders in the medical community as well with global regulatory authorities.  Perform medical review of single cases for assigned products.
    • Manage safety surveillance for assigned compounds/products. Manage collection, in cooperation with a PV vendor, of current data for safety signaling and identify and investigate safety signals.  Conduct analysis of safety data.  Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed Proficient Life Pharma products including decisions on seriousness, expectedness, and causality.  Contributing to the development and implementation of risk minimization action plans.
    • Provide safety strategic leadership for clinical development programs/program teams. Integrate the safety scientific component to build a strategic framework for clinical development plans.
    • Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Translational Medicine.
    • Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.

Basic Qualifications:

    • MD, or MD PhD, or MD MPH required; sub specialty training highly desirable
    • Minimum of 5-years of experience in clinical development or drug safety required, including management of large complex programs and cross-functional teams
    • Excellent communication skills (oral and written) and excellent organizational skills.
    • Demonstrated leadership skills with broad business orientation

Demonstrated sense of urgency and accountability for both individual and team-owned work products.

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E-mail

All e-mails should include the specific job code in the subject line, resumes should be attached as PDF’s and sent to  careers@proficientlifepharma.com
No phone calls please.