Senior Medical Director, Clinical Research, Endocrinology

This is a fully remote position, open to applicants in California.

📋 Description

• Serve as the clinical leader for one or more endocrinology programs, playing a key role in the development of clinical strategies and plans.

• Participate as a member of global project teams and development sub-teams.

• Act as the Clinical Research expert in the creation and ongoing updates of the Target Product Profile (TPP).

• Direct the formulation of the Clinical Development Plan (CDP) for each pursued indication, utilizing the TPP as a guiding framework.

• Establish the scientific rationale and design outlined in the Clinical Study Outline for each study included in the CDP.

• Facilitate discussions and supervise the drafting of the study synopsis, study protocol, and any amendments.

• Review or manage the examination of data entered into the EDC regarding events of interest or those requiring further investigation.

• Provide senior-level medical monitoring and safety oversight in collaboration with pharmacovigilance.

• Work in conjunction with other departments on all matters related to the execution and analysis of clinical study results.

• Utilize findings and additional analyses to contribute to trial-related advisory boards, lead investigator meetings, and protocol training sessions.

• Assist in advisory boards, engage with key opinion leaders, and foster external scientific collaborations.

• Play a role in developing relevant sections of regulatory documents, including protocol amendments and responses to inquiries from Health Authorities.

⛳️ Requirements

• MD degree.

• Over 10 years of experience in the industry, clinical/medical practice, or a combination of both.

• More than 5 years of program management experience.

• Background in clinical practice in internal medicine/endocrinology.

• Experience in designing, planning, and executing First-in-Human studies, Phase 2 proof-of-concept studies, and ideally global phase 3 trials.

• Familiarity with the application of biomarkers.

• Experience in interacting with the FDA and/or EU regulatory agencies is advantageous.

• Strong foundational knowledge of GCP, ICH guidelines, regulatory requirements, and trial design.

• Extensive knowledge and high-level expertise in daily medical monitoring of clinical trials.

🏝️ Benefits

• Comprehensive health insurance plans for employees and their families, covering medical, dental, vision, and basic life insurance.

• 20 days of paid time off (PTO).

• 10 paid holidays.

• Company-wide shutdown during winter.

• Discretionary annual target bonus.

• Stock options available.

• 401(k) matching.