Exec/Sr Medical Director - Oakland, United States - Meet Recruitment

Description

The Executive/Senior Medical Director, Clinical Development will play a vital role in shaping the scientific, clinical, and operational aspects of our client's clinical development programs, focusing on study and program-specific activities. This position will lead the design, planning, and implementation of study protocols for assigned investigational products, supporting related regulatory activities. Working closely with cross-functional teams, including clinical science groups and partner organizations, they will oversee the design, execution, and medical monitoring of clinical trials, ensuring effective communication with internal and external stakeholders. Additionally, they will support internal process improvement initiatives within the clinical department.

Responsibilities:

• Partner with cross-functional teams to oversee the design and conduct of clinical studies, ensuring operational feasibility, data management deliverables, and communication plans.
• Perform medical and safety data reviews, analyze trial results, and communicate clear overviews for internal presentations, publications, and regulatory purposes.
• Provide organizational support for data review committees and author clinical study documents, including protocols, clinical study reports, and regulatory documents.
• Interact with internal and external stakeholders to support program-level development strategy and clinical trial objectives.
• Act as a recognized clinical expert for assigned programs, supporting Medical Affairs, regulatory interactions, and publication strategies.
• Interact closely with regulatory agencies, support regulatory submissions, and conduct literature reviews as needed.

Qualifications:

• MD or MD/PhD with 3+ years of experience (for board eligible or certified oncologists) or 5+ years (for those without formal oncology training) in pharmaceutical or biotechnology companies.
• Experience in oncology or malignant hematology, with a strong understanding of clinical research, safety, and efficacy.
• Familiarity with pharmacovigilance, statistical principles, and regulatory requirements.
• Ability to think strategically and tactically, with excellent communication and decision-making skills.
• Proficiency in working effectively in a fast-paced, team-based environment, handling multiple projects, and adapting to changing needs.