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Medical Director
3 weeks ago
Scienta is partnering with life science organizations to optimize their hiring process and identify the best talent.
Position OverviewWe are seeking an experienced Medical Director specializing in Oncology to lead our global clinical development programs. The successful candidate will provide medical and scientific leadership, overseeing the design, execution, and interpretation of clinical trials, ensuring alignment with regulatory standards and company objectives.
Key Responsibilities:
- Clinical Development Leadership: Manage the direction, planning, execution, and interpretation of clinical trials or research activities across one or more clinical development programs. Ensure that clinical trials are conducted in compliance with applicable regulations, guidelines, and company policies.
- Clinical Document Development: Contribute to the creation and review of essential clinical documents, including trial synopses, protocols, medical monitoring plans, investigator brochures, eCRF-related documents, safety reports (e.g., DSUR/PSUR/RMP), and data monitoring committee materials.
- Regulatory Strategy and Submissions: Develop and implement clinical regulatory strategies globally, contributing to submissions and engaging in interactions with Health Authorities to facilitate product approvals.
- Product Lifecycle Support: Provide medical and scientific input into key documents supporting product registration, market access, and commercialization efforts.
- Scientific Publications and Disclosures: Strategically plan, author, and review publications and other scientific data disclosures to disseminate research findings and support the company's scientific reputation.
- Stakeholder Engagement: Establish and maintain relationships with external stakeholders, including partners, academic institutions, Key Opinion Leaders (KOLs), investigators, and consultants. Plan and conduct global advisory boards to gather insights and guide clinical development strategies.
Qualifications:
- MD Educated or equivalent.
- A minimum of 7 years of experience in clinical development within the biotechnology or pharmaceutical industry, focusing on oncology.
- Essential to have prior experience interacting with regulatory agencies such as the FDA or EMA.
- Proven track record in designing and executing clinical trials, with a deep understanding of regulatory requirements and clinical development processes.
