The Biosimilars Executive Medical Director will serve as Global Development Leader (GDL) for clinical development of key assets and oversee the inflammation biosimilars portfolio, as well as the head of the biosimilars scientific affairs team.
The GDL represents the unified global medical voice and is the single point of accountability for evidence generation and scientific communication. The GDL is also responsible for developing and executing the global scientific/medical evidence plan, collaborating cross-functionally and globally to integrate broad medical, scientific, and commercial input into the program and approving medical and scientific content of Regulatory, Safety, Scientific Affairs, and Commercial outputs.
Key Activities include the following:
- Oversee activities related to planning for studies across the product lifecycle for Biosimilars inflammation portfolio
- Interpret and integrate the results of research programs (e.g. study data, competitor data, publications) into the overall program strategy
- Provide input to regulatory and safety groups for queries from regulatory agencies and negotiate with these groups
- Provide medical and scientific input into key deliverables (e.g., regulatory filings and interactions, protocols, clinical study reports, publications and reimbursement submissions)
- Provide strategic medical input into all aspects of the Commercialization process (pre-clinical through launch)
- Approve medical/scientific components of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial materials and outputs
- Communicate current safety and efficacy/effectiveness status of the product internally and externally
- Review, approve, and execute product specific publication plan as development lead
- Oversee the Biosimilars Scientific Affairs team responsible for global scientific affairs and publication plan
- Oversee the development and execution of global Biosimilars medical plan and regional partnerships
- Oversee the development and execution of global publication plan
- Provide medical support for licensing activities and support partner relationships as needed
Leadership, Collaboration and Management
- Lead Global Development Team and represent the team in Multidisciplinary and Senior Management Interactions
- Collaborate on multidisciplinary product team with the Commercial Lead, Regulatory Lead, and Operations Lead
- Mentor, coach, and oversee the performance of direct reports
- Provide oversight and ensure alignment between clinical development and development operations.
- Provide medical/scientific support to other functions as appropriate
- Support regional needs for medical/scientific evidence generation
- Develop key relationships with global opinion leaders
- Proven success in development and execution of clinical trials
- Excellent knowledge of disease states in therapeutic area
- Familiar with investigators or institutions in therapeutic area
- Knowledge of regulatory affairs and drug safety
- Proven track record in publications
- Proven track record in commercialization and business practices
- Documented success leading, managing and motivating staff in a complex, multi-functional matrix environment
• MD plus accredited residency
• Five (5) + years of either industry or academic research experience
• Accredited fellowship in relevant specialty or sub-specialty (eg, internal medicine, Rheumatology, gastroenterology), board certified
• Eight (8) + years of industry research experience
• Previous management experience
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO Company)
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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