Director, Clinical Pharmacology

SERVIER MONDE

1d • Hybrid

About The Position

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. The Clinical Pharmacology Department under Translational Medicine at Servier is seeking a dedicated 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 and mass balance studies. At the project level, the individual may lead the Clinical Pharmacology sub-team and represent this team to the project/asset core team.

Requirements

• Advanced degree (MD, MD/PhD, PhD or PharmD) in clinical pharmacology, pharmaceutical sciences or related fields such as pharmacokinetics, pharmacology or drug metabolism
• Minimum of 8 years of 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
• Deep expertise in pharmacokinetic/pharmacodynamics, drug metabolism, drug-drug interactions, and population PKPD and PBPK modelling
• Hands-on experience using tools such as NONMEM, R, WinNonlin, and SimCyp
• 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

Nice To Haves

• Broad familiarity with the drug development process, particularly for oncology, is highly desirable
• Prior experience working with CROs

Responsibilities

• Independently represent Clinical Pharmacology department as a core member of clinical development teams
• Contribute to clinical trial designs
• Author clinical study protocols
• Execute and coordinate clinical trial conduct
• Finalize clinical study reports
• Design and follow through 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 as the subject-matter expert in regulatory interactions, including preparation of regulatory documentation and participation in meetings with regulatory agencies
• Actively lead cross-departmental teams, department-wide initiatives and workstreams
• Present and publish internally and externally as main contributor to enhance visibility of Servier’s Clinical Pharmacology department
• Ability to coach/mentor junior members of the Clinical Pharmacology team

Benefits

• competitive and comprehensive benefits package
• medical
• dental
• vision
• flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off)
• 401(k)
• life and disability insurance
• recognition programs
• Short-Term and Long-Term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 251-500 employees