Amgen Intercontinental Medical Director, Oncology/Hematology and Biosimilars in Thousand Oaks, California

Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms - Bispecific T Cell Engagers (BiTEĀ®s), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules - across many targets and more than a dozen tumor types. For decades we've been delivering essential supportive care therapies for oncology patients and we believe the best is yet to come - and we need your help! We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules - and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

To support our efforts we are hiring a Intercontinental Region Medical Director and TA Head for Oncology/Hematology, Biosimilars. In this role you will drive the development and execution of TA medical strategies to maximize Amgen's value proposition of in-line and pipeline products in alignment with global medical and brand strategies. In this role, the TA Head will partner very closely with the Global Development organization and the commercial and access Oncology Regional Leads to prepare for the launches of new products, both in hematology and solid tumor, as well as establish a close partnership with the affiliate medical leads to ensure proper global to affiliate alignment for the commercial portfolio. The TA Head is a member of the leadership team for the Intercontinental Medical organization.

  • Accountable for the development and execution of regional TA medical strategies including launch support and lifecycle management, in collaboration with Product Team/Portfolio governance and alignment with Global Medical strategy

  • Ensure strategic alignment within regional Medical teams and cross functional stakeholders

  • Accountable for the development of regional evidence generation strategy and study execution across Oncology/Hematology TA

  • Provide Oncology/Hematology and Biosimilars medical expertise on clinical content and scientific messages across publications and materials

  • Partner with Global Regulatory Affairs and Safety (GRAAS) in risk management/minimization activities

  • Collaborate with cross functional leadership in the Brand Planning Process to ensure alignment

  • Provide strategic input into development of advocacy plans and strategies in partnership with internal stakeholders

  • Accountable for budget planning and execution within Oncology/Hematology and Biosimilars TA

  • Accountable for maintaining and initiating Tier 1 expert networks throughout the region with clear deliverables

  • Travel internationally 20-30% of time

Key Activities:

  • Accountable for delivery of regional inputs to Global Medical Strategic Framework(s)

  • Ensure development of stakeholder mapping and Scientific Engagement Plan strategy

  • Regional accountability for clinical trial conduct within Oncology/Hematology TA

  • Provide medical input into Global Development strategies

  • Develop and maintain relationships with external healthcare community, including interactions with opinion leaders, payers and societies for scientific exchange

  • Provide strategic input into regional medical communication and education activities

  • Provide strategic input into data interpretation, analysis and communication

  • Medical input into label and regulatory interactions

  • Recruitment, retention, coaching, mentoring and developing departmental staff

  • Provide Oncology/Hematology and Biosimilar medical training

  • Ensure Oncology/Hematology TA compliance adherence

  • Ensure close collaboration and partnership with Site Management

  • Ensure patient-centered focus across all activities

  • Member of Regional Medical Leadership Team to help drive regional medical vision and strategy

  • Gather and synthesize insights to inform Regional and Global Strategy

Basic Qualifications:

  • MD or PhD with proven track record of leading teams

  • Two (2) or more years of clinical research experience and/or basic science research

  • Two (2) or more years in clinical research/medical affairs experience in biopharmaceutical industry (biotech or pharmaceutical)

Preferred Qualifications:

  • MD plus accredited fellowship in Oncology/Hematology, board certified or board eligible

  • Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities

  • Five (5) or more years of clinical research/medical affairs experience in the biopharmaceutical industry (biotech or pharmaceutical)

Experience :

  • Experience with clinical study management and conduct

  • Experience with developing and executing Medical Affairs strategies

  • Familiarity with health care compliance considerations

  • Experience with opinion leader interactions

  • Experience with payer and provider organizations

  • Broad and formal leadership experience including staff management

Knowledge:

  • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

  • Familiarity with concepts of clinical research and clinical trial design, including biostatistics

  • Deep medical knowledge in Oncology/Hematology

  • Sound scientific and clinical judgment

  • Familiarity with regulatory organizations, guidelines, and practices

  • Knowledge of Good Clinical Practices (GCP)

  • Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication

  • Demonstrated ability as a medical expert in a complex matrix environment

  • History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues

  • Knowledge of pharmaceutical product development, product lifecycle and commercialization process with advanced understanding of other functions; including, but not limited to, Clinical Operations, Commercial, Regulatory, and Medical Affairs

  • Network of clinical contacts in Oncology/Hematology

  • Finance and budgeting experience, resource management experience

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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.