Executive Medical Director, Global Development (GDL) Bone

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-31475
The Bone and Nephrology Therapeutic Area is looking for a Global Development Leader (GDL) to contribute to the development of the global product strategy as the authority of clinical medicine and science. The GDL will lead the global development strategy from Phase 2 and beyond.
This position may be located in:
Thousand Oaks, California
Cambridge, Massachusetts
or South San Francisco, California
Key activities and responsibilities include the following:
Provide deep medical insights in disease biology, product attributes, and clinical trial design into the development of Product Team strategic options and Global Product Strategy
As a core member of the Product Team, contribute to the Global Product Strategy and represent the unified, cross-functional Evidence Generation Team (EGT) voice in program strategic options.
Lead the design and implementation of the Total Evidence Generation Plan (EGP), through the effective leadership of the Evidence Generation Team.
Lead the EGT in the development, implementation, and interpretation of the total evidence package to define and evolve the product profile throughout the lifecycle of the asset (e.g., registrational, non-registrational, real world evidence).
Lead the design and execution of novel and adaptive evidence generation techniques that balance innovation with cost-disciplined science.
Collaborate cross functionally / regionally to ensure the EGP balances multiple stakeholder needs with product attributes and delivers globally-relevant data throughout the product lifecycle.
Lead development of study documents (e.g., Outlines, Protocols, Risk Assessment, Data Management Plans) for global clinical studies.
Partner with Global Development Operations and Amgen country organizations to ensure timely delivery of high quality global clinical data.
Support the Global Medical Team in capturing and translating local / regional data gaps into actionable EGPs, in alignment with global product strategy and global EGP.
Partner with Global Regulatory Affairs, Global Safety and Global Value and Access to define and maintain product benefit/risk profile and facilitate global registration and reimbursement. Provide medical / scientific leadership and input into:
Key regulatory/safety deliverables (e.g., core labeling documents, global regulatory submissions, and periodic safety update reports).
Regulatory responses; Represent all clinical and development aspects during regulatory authority meetings (e.g., advisory committee meetings, label negotiations).
Health authority queries and benefit/risk assessments throughout the product lifecycle.
Global Value Dossier and payer negotiations.
Partner with Global Medical organization and contribute to:
Global evidence communication through development of Global Publication Plans.
Global Core Content (e.g., disease state, clinical trial letters) creation.
Share total evidence and biologic insights with: internal stakeholders to inform their strategies/deliverables; external stakeholders to seek expert advice to inform development strategies.
Manage relationships with alliance partners to ensure alignment and execute on development strategy and evidence generation plans:
Provide strategic medical input into Licensing and Business Development strategies.
Manage a high performing Evidence Generation Team and develop staff:
Mentor, coach, and oversee the performance of direct reports, provide feedback on EGT members.
As the clinical expert on the product, communicate the total evidence and biologic insights with internal stakeholders to align & inform their strategies, and with external stakeholders (KOLs / investigators, regulators, and payers) to shape the practice of medicine.
In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale.
In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials.
Medical knowledge in the relevant therapeutic area.
Sound scientific and clinical judgment.
Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups.
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements.
Understanding of new drug commercialization and business practices.
Understanding of resourcing and budgeting.
Proven ability to lead, manage, and motivate others in a complex, multi-functional matrix environment.
Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication.
Demonstrated ability to organize and lead expert Clinical Research Advisory Panels.
History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
Superior analytical and problem solving.
Strong written and verbal communications.
Influence and negotiation.
Management of budget, processes and people.
Coaching and mentoring and developing scientific talent.
Learning agility, flexibility, creativity and innovation based on program constraints.
Five (5) or more years of clinical research experience and/or basic science research experience.
Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company).
MD plus accredited residency in relevant sub-specialty, board certified or equivalent.
Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities.
Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company).
Previous management experience.
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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