Medical Director

Actalent - San Diego, CA

Full-time - Senior

San Diego, CA

10,001+ employees

Administrative and Support Services

About the position

The Medical Director for Clinical Development and Operations at Actalent is responsible for overseeing the medical aspects of clinical programs, particularly in oncology. This role involves working closely with clinical project teams to ensure high-quality execution of clinical trials, optimizing study designs, and effectively communicating clinical data to stakeholders. The position requires a strong background in clinical development, particularly within the biopharmaceutical industry, and emphasizes collaboration with various internal and external partners.

Responsibilities

• Serve as a Study Medical Monitor, authoring clinical trial documents including protocols, investigator brochures, ICFs, training materials, and DSURs.
• Provide clinical development support and scientific opinion to study teams.
• Contribute to the development and optimization of clinical trial study designs.
• Work closely with Clinical Operations to execute clinical trials with high quality, deliver results and meet target timelines.
• Drive contribution of clinical content for deliverables in support of regulatory submission activities and ensure flow and accuracy of key data for clinical module sections of the IND.
• Provide medical input for the clinical database build, CRFs, monitoring plan, data management plan, safety monitoring plan and statistical analysis plans.
• Contribute to the ongoing scientific review of clinical trial data and assist with query generation/resolution and data analysis.
• Work closely with PV, Data Management, and other vendors to ensure appropriate review and documentation of clinical trial data.
• Maintain scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Stay abreast of internal and external developments, trends, and other dynamics relevant to the work to maintain a fully current view.
• Develop and maintain relationships with a variety of internal and external partners and stakeholders, including clinical investigators, study coordinators/CRAs, and KOLs.
• Review and manage clinical development budgets and provide forecasts to the clinical development and finance team members.

Requirements

• Medical Degree (MD or DO) preferably board certified in medical oncology.
• 5+ years' experience in clinical development with at least 2 years in the biopharmaceutical industry.
• Solid understanding of GCP/ICH/IRB and local regulatory authority drug research and development guidelines and regulations.
• Proven ability to interact and work with external partners (PIs and consultants) with regards to clinical development functions.
• Solid understanding of the clinical trial processes, such as study start up, patient recruitment and safety, non-compliance, management, and monitoring of investigative sites.
• Excellent problem-solving skills, a strong sense of urgency and keen attention to detail.
• Well organized with the ability to effectively manage multiple priorities in a dynamic, cross-functional teamwork environment under time and resource pressures.
• A proven track record of successfully working within a collaborative team environment and building positive relationships as an individual contributor is required.
• Excellent oral and written communication skills and strong organizational skills are required.
• Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes.

Nice-to-haves

• Experience in translational medicine/early phase oncology clinical trials is a plus.