Senior Medical Director

Description:

We are seeking a Senior Medical Director to join our Clinical Development team. The Senior Medical Director is responsible for providing medical direction, management and review of clinical trials and product development. Specific tasks may include design of clinical development program plans, as well as clinical protocol development, medical monitoring of clinical trials, and analysis of study data and preparation of trial reports and related regulatory documents. The individual may also serve as a Development Project Leader for a specific asset and will interact with most functions to ensure the successful progress of projects and clinical trials. This individual will have a solid understanding of all phases of clinical drug development with particular expertise in late development, excellent written and effective verbal communication skills, ability to influence across functions and levels, and flexibility/adaptability to work in a fast-paced environment are essential.

This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.

Reporting to: Senior Medical Director, Late Clinical Development

Job Description What you’ll do:

• Applies disease knowledge to clinical research trial development
• Drives protocol development for clinical studies in collaboration with Clinical Operations and other clinical sub-team functions
• Drives preparation of clinical development plans in partnership with cross-functional team
• Works collaboratively with Regulatory Affairs; drafts clinical scientific documents such as NDA,, Investigator Brochures, Annual Reports (DSUR), and other FDA/HA submissions
• Contributes to CSR preparation and finalization
• Contributes to development of CRFs and data review plans
• Monitors, and reviews safety and efficacy data in ongoing studies
• Serves as primary clinical point of contact (eligibility questions, AE management…) for clinical trial sites
• Develops clinical abstracts, and/or presents data at scientific meetings, SIVs, and conducts protocol training
• Develops and participates in advisory boards
• Acts as a clinical representative in cross-functional teams,
• Serves as clinical partner to Business Development

Requirements

• Medical degree required;
• Experience in Phase 3 trial conduct, design, and execution.phase development preferred
• Thorough understanding of oncology clinical trial design, P1-P3.
• Experience and understanding of clinical trial data monitoring and all aspects of drug development
• Knowledge of GCP and ICH guidelines
• A proven self-starter and team player with strong interpersonal skills who establishes & nurtures highly effective relationships with colleagues and key stakeholders to support and advance project goals and objectives
• Critical thinker with a solutions-oriented mindset
• Self-motivated to work effectively in a dynamic environment
• Possess strong organizational skills and conflict resolution abilities