Director Pharmacometrics - Permanent - Cambridge, MA
Lead the science, shape the strategy-drive innovation through data as Director of Pharmacometrics.
Proclinical is looking for a Director of Pharmacometrics to join a team at the forefront of Model-Informed Drug Development (MIDD), shaping decisions across the drug development continuum-from non-clinical research to post-submission. As the Pharmacometrician Director, you will lead the implementation of MIDD strategies across therapeutic areas such as oncology, neurology, and rare disease programs.
If you are passionate about quantitative science and innovation, this is your opportunity to make a meaningful impact on drug development.
Primary Responsibilities:
The successful candidate will play a critical role in integrating quantitative modeling to accelerate the development of innovative therapeutics, including small molecules, antibodies, and antibody-drug conjugates (ADCs).
This position requires a recognized subject matter expert in pharmacometrics who can guide multiple programs, influence strategic decisions, and foster cross-functional collaboration to achieve impactful outcomes.
Responsibilities:
Technical Competencies
1. Define and implement Pharmacometrics strategies:
- Lead the development and execution of Pharmacometrics (PMx) plans for New Chemical Entities (NCEs) and New Biological Entities (NBEs) to support regulatory submissions.
- Drive the PMx strategy across non-clinical and clinical projects, contributing to modeling and simulation activities to guide drug development decisions.
- Identify opportunities to leverage Model-Informed Drug Development (MIDD) to optimize study designs and enhance program success.
- Inform drug development strategies to support decision-making and successful approvals.
2. Contribute to PMx documentation and regulatory submissions:
- Ensure the timely delivery and high quality of PMx documents, including dataset specifications, analysis plans, and reports.
- Collaboratively author and review key documents where PMx is a contributor, such as clinical development plans, pediatric investigational plans, and submission packages.
3. Communicate PMx insights and influence cross-functional teams:
- Represent the PMx group in project teams and cross-functional initiatives.
- Collaborate with teams across early development, pharmacology, biometry, and clinical operations.
- Participate in internal and external working groups, scientific conferences, and publications to share PMx insights and best practices.
4. Conduct and oversee hands-on PMx activities:
- Perform or supervise modeling and simulation activities, including population PK-PD, exposure-response, disease progression, and minimal PBPK modeling.
- Support the design and optimization of non-clinical and clinical trials using simulation and optimal design methods.
- Develop and implement innovative PMx methodologies to advance program objectives.
- Stay current with emerging PMx approaches and technologies.
- Plan budgets and manage subcontracted PMx activities, including PK-PD and PBPK studies.
5. EHS responsibilities:
- Respect and enforce applicable EHS regulations and procedures.
- Promote EHS dynamics within teams for the proper functioning of the EHS management system.
- Participate in the prevention of workplace accidents by carrying out Managerial Safety Visits (VMS) for employees.
- Ensure the completion of mandatory EHS training.
Knowledge & Experience:
Essential
- At least 6 years of experience in Pharmacometrics within the pharmaceutical industry, contract research organizations (CROs), regulatory agencies, or academia.
- Proficiency in modeling and simulation techniques, including Population PK-PD, Translational PK-PD, tumor growth models, time-to-event models, joint modeling, and item-response theory.
- Experience with regulatory submissions (e.g., Module 2.7.2 - Clinical Pharmacology Overview) and interactions with regulatory agencies.
- Strong expertise in at least one PMx software (e.g., NONMEM or MONOLIX).
- Proficiency in data management, plot generation, and statistical software (e.g., R).
- Strong analytical and problem-solving skills.
- Excellent scientific writing, interpersonal communication, and networking skills.
- Attention to detail in a time-sensitive environment.
- Familiarity with good clinical-laboratory practices (GxPs).
- Experience working with CROs.
Preferred:
- Experience in small molecules, antibodies, and ADCs.
Education & Certifications:
Essential
- PhD, MD, or master's degree from an accredited institution in Medicine, Pharmacometrics, Clinical
Pharmacology, Pharmacy, Mathematics, Biology, Statistics, or a related field. - At least 6 years of experience in the pharmaceutical industry, CROs, regulatory agencies, or academia.
Preferred:
- Experience in oncology and rare diseases.
Compensation:
- $185 000.00 - $200 000.00 Per Annum
If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at s.amark@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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