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Senior Medical Director Oncology
143008
Posted:
11th
April 2024
- 330000 USD - 380000 USD
- Hayward, United States
- Permanent
.
Title: Senior Medical Director, Clinical Development
Description: The Senior Medical Director, Clinical Development is a vital contributor to clinical development programs, overseeing study-specific activities, collaborating with cross-functional teams, and supporting regulatory activities. Responsibilities include protocol design, data analysis, committee support, document authorship, stakeholder interaction, publication strategy, regulatory engagement, and literature reviews.
Responsibilities:
- Protocol Development: Lead the creation of study protocols for investigational products, ensuring compliance with regulations and operational feasibility.
- Clinical Study Oversight: Manage the execution of clinical studies, including data management, safety monitoring, and study closure.
- Committee Support: Facilitate Data Monitoring Committees and other data review committees, preparing updates and synthesizing data reports.
- Document Preparation: Author clinical study reports, investigator brochures, and other regulatory documents. Develop training materials for study teams.
- Stakeholder Engagement: Interact with internal and external stakeholders, providing guidance and support for program-level development strategy and clinical trial objectives.
- Clinical Expertise: Serve as a clinical expert for assigned programs, collaborating with Medical Affairs on Investigator-Sponsored Trials (ISTs) and publication strategy.
- Regulatory Collaboration: Work with Regulatory Affairs on submissions, investigator brochures, and communication with regulatory agencies.
- Publication Strategy: Contribute to publication strategy execution, including abstracts, posters, and presentations at scientific meetings and conferences.
- Literature Review: Conduct literature reviews to inform development strategy and scientific hypotheses. Stay updated on relevant literature for program development.
Qualifications:
- MD or MD/PhD with 3+ years (5+ without oncology training) in pharmaceutical or biotech as (Associate) Medical Director.
- Expertise in oncology or malignant hematology, with strong analytical skills REQUIRED!
- Desired experience in health authority interactions and regulatory submissions.
- Strategic thinker with excellent communication and decision-making abilities.
- Flexible and able to manage multiple projects independently.
Location: Remote
Martin Wenzel
Division Director