Executive Medical Director, Global Safety

Amgen • Thousand Oaks, CA

22d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Therapeutic Area Head, Safety – Hematology/Oncology What you will do Let’s do this. Let’s change the world. In this vital role 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 are accountable for the safety strategy and major safety deliverables for each product. You will lead the Heme-Onc safety teams and are accountable for staff management and resource planning/allocation. You will serve as a member of Global Patient Safety Leadership team and will support the Head of Therapeutic Area Safety (TAS) in the establishment of 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.

Requirements

• 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

Nice To Haves

• 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 the accomplishment of 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 behaviors with their staff
• They will also embody the Amgen leadership attributes which are: Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

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 (TA) 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

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree