Amgen

Executive Medical Director, Biosimilars

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Mar 22, 2019
Ref
R-70932
Required Education
Doctorate/PHD/MD
Position Type
Full time
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen helped to develop the science used in making biologic medicines, and we remain a leader in designing and manufacturing new biologics. This expertise is now being applied to the challenge of making high-quality oncology biosimilars.

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:
  • Scientific
    • 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
    • Deliver 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)
    • Issue 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
    • Manage the development and execution of global Biosimilars medical plan and regional partnerships
    • Guide 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.
    • Supply medical/scientific support to other functions as appropriate
    • Support regional needs for medical/scientific evidence generation
    • Develop key relationships with global opinion leaders
  • Knowledge
    • Development and execution of clinical trials
    • Experience with chronic disease states in a variety of therapeutic areas
    • Familiar with investigators or institutions in various therapeutic areas
    • Experience with regulatory affairs and drug safety as well as publications, commercialization and business practices
    • Leading, managing and motivating staff in a complex, multi-functional matrix environment


Basic Qualifications:
  • MD or DO degree from an accredited medical school AND
  • Five or more years of either industry or academic research experience AND
  • Previous management experience


Preferred Qualifications:
  • Accredited fellowship in relevant specialty or sub-specialty (eg. internal medicine, Rheumatology, gastroenterology), board certified
  • Eight (8) + years of industry research experience
  • Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO Company)