Associate Director, Clinical Pharmacology

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Full-time Employment / Unlimited

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About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision.

Role Summary

The Clinical Pharmacology Department under Translation Medicine at Servier is seeking a dedicated Associate Director, Clinical Pharmacology to support oncology programs across all phases of clinical development. The individual will be accountable for developing and executing clinical pharmacology strategies and independently represent the department on clinical study and program teams. The role involves strong cross-functional collaboration with internal and external partners, including Clinical Operations, Biostatistics, Data Management, Medical Writing, Regulatory, Safety, Technical Operations and regulatory agencies, to advance drug candidates in an efficient and scientifically rigorous manner.

Key responsibilities include designing, executing, interpreting and reporting studies including but not limited to first-in-human, drug interaction, biopharmaceutics, specific populations, and mass balance studies.

• Independently represent Clinical Pharmacology department as a core member of clinical development teams:
• Contributing to clinical trial designs
• Author clinical study protocols
• Execute and coordinate clinical trial conduct
• Finalize clinical study reports
• Develop and execute program specific clinical pharmacology strategy and plan. Align plans with sub-teams, study teams, manager and departmental senior staff.
• Manage CROs for clinical pharmacology related studies and activities
• Review and interpret PK/PD data generated during conduct of the clinical trials
• Participate in the dose selection for first-in-human studies, Go/No Go decisions when needed
• Communicate results and impact of results in a timely and effective manner to clinical study teams and development sub-teams.
• Represent Clinical Pharmacology in regulatory interactions, including preparation of regulatory documentation and participation in meetings with regulatory agencies
• Actively participate in cross-departmental teams, department-wide initiatives and work streams.
• Present and publish internally and externally as main contributor to enhance visibility of Servier’s Clinical Pharmacology department.

• Advanced degree (MD, MD/PhD, PhD or Pharm
  
  D) required with post-graduate training in clinical pharmacology, pharmaceutical sciences or related fields such as pharmacokinetics, pharmacology or drug metabolism.
• Minimum of 8 years of professional experience working as a clinical pharmacologist in pharmaceutical industry, research institutions and/or regulatory agencies, with a strong track record in designing, interpreting, and reporting clinical pharmacology studies
• Expertise in pharmacokinetic/pharmacodynamics, drug metabolism, drug-drug interactions, and population PKPD and PBPK modelling, with hands-on experience using tools such as NONMEM, R, Win Nonlin, and Sim Cyp
• Broad familiarity with the drug development process, particularly for oncology, is highly desirable as is prior experience working with CROs
• Strong interpersonal, organizational, and communication skills; able to work independently and effectively within a collaborative matrix team environment
• Ability to make sound judgement, adapt to changing business needs, and manage multiple priorities in complex settings

• 5% domestic and international travel
• Boston – hybrid is preferred, open to remote work

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our…