Clinical Pharmacology Lead - AD/Sr AD (Remote)

BioCT Innovation Commons; Ridgefield (CT); Hybrid; USD 140.000 - 294.000; Vollzeit

Zusammenfassung

Boehringer Ingelheim Pharmaceuticals Incorporated seeks an Associate Director or Senior Associate Director Lead in Clinical Pharmacology at the Ridgefield, CT site. The role focuses on designing CP development strategies and communicating CP topics to regulatory authorities during drug development and submission.

Responsibilities include leading CP strategy, collaborating with TMCP and ECO teams, and mentoring TCPs while supporting SoD, PoCP, and post-submission activities.

Qualifikationen

• Doctoral or Master’s degree with CP focus; regulatory/academic experience preferred.
• 3–5 years CP experience for mid-senior level pathway; strong PK/PD knowledge required.
• Experience with regulatory interactions and clinical drug development is essential.

Aufgaben

• Lead CP strategy development and implement CP plans across projects.
• Represent Clin Pharm in PMO, internal and external meetings.
• Collaborate with cross-functional teams to support SoD, PoCP, and product submission activities.

Kenntnisse

NONMEM

PK/PD

Clinical Pharmacology

Regulatory knowledge

Team leadership

Ausbildung

MD or PhD in Medicine/Pharmaceutical Sciences/CP

MS in Medicine/Pharmaceutics/CP

Tools

Monolix

R

SAS

PBPK software

Jobbeschreibung

Boehringer Ingelheim Pharmaceuticals Incorporated seeks an Associate Director or Senior Associate Director Lead in Clinical Pharmacology at the Ridgefield, CT site. The role focuses on designing CP development strategies and communicating CP topics to regulatory authorities during drug development and submission.

Responsibilities include leading CP strategy, collaborating with TMCP and ECO teams, and mentoring TCPs while supporting SoD, PoCP, and post-submission activities.