Chief Clinical Pharmacology & Translational PK Strategy

Certara; United States; On-site; USD 180,000 - 280,000; Full time

Job summary

Certara, a leader in biosimulation software and services, accelerates drug development by delivering quantitative pharmacology solutions to clients worldwide. We seek a senior clinical pharmacology professional to guide strategy, design and execution of pharmacology programs across IND through NDA/BLA, collaborating with multidisciplinary teams and health authorities.

You will mentor scientists, develop innovative approaches, and help win new business while ensuring regulatory readiness.

Qualifications

• Experienced in design and stewardship of clinical pharmacology components of development plans.
• 12+ years of experience in the pharmaceutical industry or government.
• Consulting experience or leadership in clinical pharmacology or drug development space.
• Experience with translational and regulatory submissions (e.g. INDs, NDAs, BLAs).
• Broad therapeutic area and small and/or biologic molecule experience.
• Experience designing and executing clinical pharmacology studies.
• Understanding multidisciplinary requirements of drug development.
• Experience building and leading successful teams.

Responsibilities

• Lead Certara teams and clients to develop clinical pharmacology programs for IND to NDA/BLA.
• Develop innovative pharmacology approaches and assemble multidisciplinary teams.
• Leverage modelling and simulation tools to inform trial designs and development strategy.
• Represent clients at meetings with global health authorities as a subject matter expert.
• Co-author documents summarizing clinical pharmacology data and program strategy.
• Interpret data to support study design and strategy and mentor staff.
• Lead business development initiatives and client scoping calls.

Skills

Clinical pharmacology

Initiative

Influence & Innovation

Client management

Mentoring

Cross-functional

Communication

Team leadership

MS Office

Education

PhD or PharmD in pharmacology/pharmacokinetics

MS in Pharmaceutical Science

Equivalent degree in related field

Job description

Certara, a leader in biosimulation software and services, accelerates drug development by delivering quantitative pharmacology solutions to clients worldwide. We seek a senior clinical pharmacology professional to guide strategy, design and execution of pharmacology programs across IND through NDA/BLA, collaborating with multidisciplinary teams and health authorities.

You will mentor scientists, develop innovative approaches, and help win new business while ensuring regulatory readiness.