Executive Medical Director, Global Safety, Hematology​/Oncology

Therapeutic Area Head, Safety Hematology/Oncology

As the Therapeutic Area Head, Safety Hematology/Oncology (Executive Director), you will serve as the safety expert for Amgen’s Heme‑Onc products globally and own the safety strategy and major safety deliverables for each product. You will lead the Heme‑Onc safety teams and be responsible for staff management and resource planning/allocation.

In this vital role, you will act as the safety expert for Amgen’s Heme‑Onc products worldwide and support the Global Patient Safety Leadership team. You will help establish a highly effective global safety organization in full compliance with worldwide regulations, reporting to the AVP Head of TAS in the Global Patient Safety organization.

• Serve as the safety expert in Hematology/Oncology.
• Provide strategic oversight and direction for all regulatory safety responses or strategic deliverables, including safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs.
• Lead the safety strategy and Benefit/Risk Management Process for the assigned portfolio and ensure TA staff provides ongoing monitoring of safety profiles for Amgen products worldwide.
• Chair and participate in safety governance meetings per SOPs and manuals.
• Oversee Hematology/Oncology input to contractual agreements with Business Partners and CROs.
• Work cross‑functionally with Development and Regulatory TA Heads to propel Heme‑Onc portfolio goals.
• Provide safety oversight, strategy, and guidance to therapeutic areas and other groups within Clinical Development, Medical Affairs, Regulatory, and the commercial organizations.
• Manage the Hematology/Oncology safety teams, providing direction and prioritizing resources to achieve goals.
• Recruit and retain talented safety professionals and provide coaching, mentoring, and development of staff.
• Ensure staff are compliant with Amgen corporate and departmental training.
• Contribute to Global Patient Safety goals.
• Participate in budget and headcount planning.
• Lead or sponsor significant cross‑functional projects, initiatives or training.
• Maintain inspection readiness.
• Represent and serve as the point of contact for Health Authority Inspection and Internal Process Audits within the remit of the role and responsibility.

We are all different, yet we all use our unique contributions to serve patients. The Executive Director/TA Head we seek is an experienced leader with the following qualifications.

• MD or DO degree from an accredited medical school.
• Five (5) years of industry or academic research experience.
• Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

• PhD with 15 years of directly related experience.
• Clinical experience in either an accredited academic setting or private practice (including hospital‑based) setting.
• Previous product safety experience and knowledge of clinical trials and drug development.
• Knowledge of Hematology/Oncology patient populations and drug classes.
• Proven history of effective leadership with a matrix organization.
• Issue and crisis management.
• Strategic leadership ability and capable of managing global teams and multifunctional teams to accomplish complex interdepartmental & international programs and projects.
• Understanding of international drug safety regulations, global pharmacovigilance, and product safety processes.
• Knowledge of general medicine, clinical care, and principles of epidemiology.
• Influencing skills with capability to present strategies, policy & work processes to diverse audiences, geographies, departments, and organization levels.
• Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives.
• Resolving critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting.
• Identifying diverse, qualified successors for key positions.
• Ensuring that direct reports who also lead people consistently demonstrate these same…