Senior Medical Director, Clinical Research, Endocrinology
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Job Description
Senior Medical Director overseeing clinical research strategies and execution for endocrine therapies. Integral role within multi-disciplinary teams in developing clinical plans and trials.
Responsibilities:
- Clinical leader of one or more endocrinology programs, being integral to developing the clinical strategy and plans
- Member of global project team(s) and development sub team(s)
- Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP)
- Lead the development of the Clinical Development Plan (CDP) for each indication being pursued, using the TPP as guidance
- Define the scientific rationale and design captured in the Clinical Study Outline for each study in the CDP
- Lead the discussions and oversee the writing of the study synopsis, study protocol and its amendments
- Review or oversee the review of the data input in the EDC for events of interest or needing further investigation
- Provide senior-level medical monitoring and safety oversight in cooperation with pharmacovigilance
- Collaborate with other departments in all topics related to the conduct and analysis of clinical study results
- Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings
- Support advisory boards, key opinion leader engagement, and external scientific collaborations
- Contribute to the development of relevant sections of regulatory documents such as amendments to protocols and responses to Health Authorities questions
Requirements:
- MD degree
- 10+ years of experience industry, clinical/medical practice or combination
- 5+ years of program management experience
- Experience from clinical practice in internal medicine/endocrinology
- Experience in designing, planning, and executing First-in-Human studies, Phase 2 proof-of-concept studies and preferably also global phase 3 trials
- Experience with application of biomarkers
- Experience interacting with the FDA and/or EU regulatory agencies is a plus
- Strong general knowledge of GCP, ICH guidelines and regulatory requirements and trial design
- Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials
Benefits:
- Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- Winter company shutdown
- Discretionary annual target bonus
- Stock options
- 401k match
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