Senior Director, Clinical Development, Translational & Experimental Medicine, CVM
The Sr. Director will serve as a Clinical Leader in the Cardiovascular /Metabolism (CVM) Translational & Experimental Medicine Group, with a focus on drug development for metabolic and cardiovascular projects.
The Sr. Director will have broad responsibilities including:
- Providing strategic leadership on managing/addressing specific project/program-related issues and presenting to and negotiating with the CVM and Janssen leadership teams on development plans or program-related issues.
- Accountable for the design the Translational Early Development Plan and the clinical development strategy for early stage compound(s), in collaboration with CVM Discovery, Biomarkers, Development, and other functional partners.
- Accountable for the medical oversight, conduct, and analysis of the appropriate first in human (FIH), proof of pharmacology (POP), proof of mechanism (POM), and proof of concept (POC) studies for NME early development programs and mechanistic trials and clinical pharmacology studies supporting all phases of development for the Metabolism and Cardiovascular portfolio.
- Leading the Clinical Team, responsible for the timely completion, content, and quality of key deliverables including protocols, clinical study reports and submissions to health agencies
- Presenting and/or responding to questions at meetings with Health Authorities.
- Providing key input into diligence activities.
- Previous Supervisory experience overseeing various position levels would be a strong asset.
Qualifications for the Senior Director Clinical Leader include:
- MD (or equivalent), MD/PhD, PhD or PharmD all with a basic science research background will be required.
- Board certification in Internal Medicine (or Pediatrics), Endocrinology is preferred, but backgrounds in Cardiology, Nephrology, and GI/Hepatology will be considered.
- Detailed and thorough understanding of metabolic disorders, including diabetes, obesity, and related comorbidity disease (e.g., cardiovascular, renal or liver disease), in drug development is required.
- Demonstrated successful post-doctoral research and publications in metabolic disorders is required
- Requires at least 7 years of experience in industry and/or academia in early development clinical research and development (including Phase 0-2a studies).
- Strong leadership skills with the ability to influence is required.
- Up to 10% annual travel (domestic and international) may be required.
Requisition ID: 0089180118