Director, Global Clinical Pharmacology & PK Modeling

Certara USA, Inc.; Wayne (PA); Sur place; USD 170 000 - 210 000; Plein temps

Résumé du poste

Certara USA, Inc. seeks a senior Clinical Pharmacology leader to drive philosophy, strategy, and execution across IND to NDA/BLA programs. You will shape development plans, leverage pharmacometrics, and guide multidisciplinary teams through regulatory submissions.

You will mentor junior scientists, collaborate with biostats, pharm/tox, and CMC, and represent clients at health authority meetings. A PhD/PharmD or MS with relevant experience is required.

Qualifications

• Experienced in design and stewardship of clinical pharmacology components of development plans.
• Regulatory success through pharmacometrics and translational work.
• Leadership in cross-functional drug development teams.

Responsabilités

• Develop clinical pharmacology strategies for IND to NDA/BLA submissions.
• Lead teams to execute pharmacology studies and program design.
• Collaborate with biostats, CMC, and regulatory groups.
• Author and co-author CSRs and regulatory documents.
• Represent clients at meetings with health authorities.
• Mentor junior PK scientists and support staff.

Connaissances

Clinical pharmacology

Pharmacokinetics

Drug development

Regulatory submissions

Cross-functional leadership

Team leadership

Mentoring

Stakeholder management

Scientific writing

Pharma industry

Formation

PhD or PharmD

MS in Pharmaceutical Science

Description du poste

Certara USA, Inc. seeks a senior Clinical Pharmacology leader to drive philosophy, strategy, and execution across IND to NDA/BLA programs. You will shape development plans, leverage pharmacometrics, and guide multidisciplinary teams through regulatory submissions.

You will mentor junior scientists, collaborate with biostats, pharm/tox, and CMC, and represent clients at health authority meetings. A PhD/PharmD or MS with relevant experience is required.