Executive Medical Director, Global Safety, Hematology/Oncology

About this role

Job Title: Executive Medical Director, Global Safety, Hematology/Oncology
Job Location: Thousand Oaks, California, United States
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
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.
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

What we expect of you
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.
Basic Qualifications:

MD or DO degree from an accredited medical school AND

Five (5) years of industry or academic research experience AND

Six (6) years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

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…