San Francisco, CA, USA
Competitive Salary and Bonus
about 1 month ago
The Medical Director, Medical Affairs performs activities associated with management and implementation of late stage hGH drug development and life-cycle management activities for marketed product(s). The Medical Director is a scientific and clinical lead in the human Growth Hormone treatment area, leading key strategic, cross-functional projects.
The Medical Director assists the VP, Medical Affairs in the development and implementation of the Company’s medical strategy for product development and works closely with multiple cross-functional teams. They are responsible for building and managing long-term relationships and strategic partnerships, and will develop and oversee phase IV clinical programs and patient registries and provides oversight of investigator-sponsored trials (ISTs) and compassionate use programs. The Medical Director coordinates clinical monitoring process in accordance with GCP’s and global SOP’s to access the safety and efficacy of post-marketed products, and will represent medical affairs at internal and external meetings of all levels, scientific conventions, and corporate liaison boards.
The position reports to the Vice President of Medical Affairs and is based in Palo Alto, CA.
• With the Chief Medical Officer and Vice President, Medical Affairs, the Medical Director, hGH Medical Affairs
helps to define strategy and develop and refine Medical Affairs policies and procedures and SOPs, to ensure
and maintain excellence in standards and practices.
• Build and manage relationships and strategic partnerships, and interact regularly with Key Opinion Leaders,
clinical investigators, healthcare customers, strategic alliance partners, vendors, professional societies and
organizations, and patient advocacy groups. Contribute into KOLs mapping. Develop KOLs engagement plans.
• Work closely with internal stakeholders including Commercial, Legal, Regulatory, Clinical Development,
Clinical Operations, Pharmacovigilance, Biometrics, Global Communications, and other functional group
contributors to ensure successful management of Medical Affairs projects.
• Work closely with Commercial and Clinical Development in designing and implementing launch strategies
and tactics, and life cycle planning.
• Provide assessments of product opportunities and threats.
• Designing and implementing medical strategies and tactical plans while providing thought leadership and
tactical execution for medical publication planning, medical education, medical information system
• Serve as a clinical and scientific expert for Medical Affairs projects within hGH program
• Develop strategic imperatives and tactical plans to enhance healthcare practitioner education to improve
• Provide leadership to the Medical Affairs team and actively participate in design and conducting Phase IIIB/IV
trials and medical materials review; serve as a Medical Monitors for these studies.
• Oversee investigator-sponsored trials (ISTs) and compassionate use programs.
• Lead the development, management and execution of US Advisory Boards.
• Foster research relationships with key research centers in the US.
• Provide medical expertise, and collaborate with Commercial, Legal, and Regulatory for development and
review of Labeling, advertising and promotional materials.
• Drive MA scientific publication plan as an author (manuscripts, abstracts, presentations) and reviewer.
• Develop and deliver presentations on MA projects to both internal and external audiences within legal,
compliance and regulatory guidelines.
Knowledge, Skills and Experience
• M.D. degree required
• At least 5 years of industry or academic experience
• Extensive knowledge in basic and clinical science, endocrinology (preferred)
• Strong track record of scientific and clinical inquiry
• Demonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic
• Demonstrated strategic and critical thinking
• Excellent communication skills (oral and written) and excellent organizational skills.
• The ability to lead directly and by influence, including strong problem solving, conflict resolution, and
• Multi-task while remaining organized and attentive to detail
• Work hard, be a trustworthy and collaborative team player
• Take initiative and solve complex problems
• Demonstrate sound judgement in terms of handling complex, confidential, and regulated information
• Ability to travel up to 50% of the time domestically and internationally