Medical Director, Early Stage Clinical Development

Work Requirement

This role will be based out of our San Francisco office and is hybrid with a minimum of 3 days per week onsite. 

Key Responsibilities

Reporting into the Vice-President, Global Clinical Development, the Medical Director, Early Stage Clinical Development:

• Provides medical/scientific, strategic and operational expertise and support for the planning and execution of IND filings and early stage clinical trials.
• Provides expert opinion on the pathophysiology and diagnosis of disease, existing and emerging treatments and unmet medical needs to inform key medical and business decisions. 
• Conducts medical monitoring of clinical trials; writes protocols, informed consent documents; responds to questions from regulatory agencies, institutional review boards and ethics committees; reviews clinical data, case report forms and ensures final accuracy of clinical trial data for clinical study reports.
• Conducts safety monitoring, oversees conduct of clinical sites for adherence to both company standards, and government/industry regulations (GCP/ICH); supports development of investigator brochures; trains investigators and travels to clinical sites to build relationships with investigators and study teams in support of study enrollment.
• Institutes and continuously improves operating procedures ensuring best practices.
• Establishes appropriate strategic partnerships with centers of excellence, advocacy groups and KOLs in the areas of scientific interest.
• Collaborates closely with key stakeholders to ensure tight strategic integration of product development plans and strategies. Plans and develops content for advisory meetings with opinion leaders and for medical symposia.
• Participates in review of  medical materials to ensure content is medically appropriate and compliant with internal and external requirements.
• Oversight of partnered clinical research operations (CRO) vendors. 
• Keeps up to date on current relevant therapeutic areas through familiarity with literature, attendance at meetings, conventions and professional associations.
   

Qualifications and Experience

• MD, PharmD or equivalent
• Minimum 10+ years of combined clinical practice and industry experience with 3-5 years of biotech or pharmaceutical experience in oncology drug development.
• Oncology fellowship training and ABIM Oncology certification preferred

Skills and Abilities

• Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
• Strong leadership skills and the ability to lead through example. 
• Strong understanding of clinical trials process with demonstrated ability to have designed and implemented programs and initiatives directed towards defined strategic objectives.
• Early stage development and regulatory experience preferable.
• Excellent organizational skills with the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
• Strong problem-solving skills with the ability to think and act strategically, anticipate roadblocks and map out next steps.
• Demonstrated high level of integrity, ethics and professionalism.
• Knowledge of scientific methods, research design and medical practices and procedures.
• Excellent writing and oral presentation skills. Demonstrated ability to communicate scientific results.
• Ability to travel.