Executive Medical Director, Global Safety, Hematology/Oncology

Role Summary

Executive Director, Therapeutic Area Head for Safety – Hematology/Oncology, serves as the safety expert for Amgen’s Hematology/Oncology products globally and is accountable for the safety strategy and major safety deliverables for each product. You will lead the Heme-Onc safety teams and are responsible for staff management and resource planning/allocation. You will be a member of Global Patient Safety Leadership team and support the Head of Therapeutic Area Safety in establishing a highly effective global safety organization in full compliance with worldwide regulations. This role reports to the AVP Head of TAS in the Global Patient Safety organization.

Responsibilities

• Serve as Safety expert in Hematology/Oncology
• Accountable for providing strategic oversight and direction for all regulatory safety responses or strategic deliverables, including but not exclusive to Safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs
• Leads the safety strategy and Benefit/Risk Management Process for assigned portfolio and ensures Therapeutic Area staff provides ongoing monitoring of safety profiles for Amgen products worldwide
• Chairs and participates in safety governance meetings per Standard Operating Procedures and Manuals
• Oversee Hematology/Oncology input to contractual agreements with Business Partners and CROs
• Works 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
• Management of the Hematology/Oncology safety teams providing direction and allowing appropriate prioritization of 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
• Leads or sponsors significant cross-functional projects, initiatives or training
• Inspection Readiness
• Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

Qualifications

• Required: MD or DO degree from an accredited medical school
• Required: Five (5) years of industry or academic research experience
• Required: Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
• Preferred: PhD with 15 years of directly related experience
• Preferred: Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
• Preferred: Previous product safety experience and knowledge of clinical trials and drug development
• Preferred: Knowledge of Hematology/Oncology patient populations and drug classes
• Preferred: Proven history of effective leadership with a matrix organization
• Preferred: Issue and crisis management
• Preferred: Strategic leadership ability and capable of managing global teams and multifunctional teams to the accomplishment of complex interdepartmental and international programs and projects
• Preferred: Understanding of international drug safety regulations, global pharmacovigilance, and product safety processes
• Preferred: Knowledge of general medicine, clinical care, and principles of epidemiology
• Preferred: Influencing skills with capability to present strategies, policy and work processes to diverse audiences, geographies, departments, and organization levels
• Preferred: Assisting staff with preparing for roles of growing responsibility and identifying new opportunities that expand their skills and align with their overall career objectives
• Preferred: Resolving critical gaps in the organization’s internal capabilities and skillsets, including strategic external recruiting
• Preferred: Identifying diverse, qualified successors for key positions
• Preferred: Ensuring that direct reports who also lead people consistently demonstrate these same behaviors with their staff