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BioSpace Thousand Oaks, United StatesJob Details · HOW MIGHT YOU DEFY IMAGINATION? · At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over ...
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Executive Director, Global Safety Head, Obesity - Thousand Oaks, United States - BioSpace, Inc.
Description
HOW MIGHT YOU DEFY IMAGINATION?At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives.
Our shared missionto serve patientshas driven our status as one of the worlds preeminent biotechnology companies, reaching over 10 million patients worldwide.
Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.
Executive Director, Global Safety Head, ObesityLive
What you will do
Lets do this. Lets change the world.
In this vital role as the Executive Director, Global Safety Head, you will serve as the safety expert for Amgens obesity products globally and are accountable for the safety strategy and major safety deliverables for each product.
You will lead the obesity safety teams and are accountable for the staff management and resource planning/allocation.You will serve as a core member of Global Patient Safety Leadership team and will support the Head of Global Patient Safety (GPS) in the establishment of a highly effective global safety organization in full compliance with worldwide regulations.
This role reports into the Head of Global Patient Safety.Responsibilities:
Serve as Safety expert in Obesity
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 Obesity Safety input to contractual agreements with Business Partners and CROs
Works cross-functionally with Development and Regulatory TA Heads to reach issue resolution
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 Obesity 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 in development
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
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Executive Director we seek is an experienced leader with the following qualifications.
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
Basic Qualifications:
MD or DO degree from an accredited medical school AND
Five (5) years of industry or academic research 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 Obesity patient populations and drug classes
Proven history of effective leadership with a matrix organization
Issue and crisis management
Strategic leadership ability and capable to manage 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 organizations 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
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.
The annual base salary range for this opportunity in the U.S. is $317,452 - $360,254.In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
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 planStock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Amgens Commitment to Our Staff
At Amgen, our mission is serving patients.
Our staff are dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses.
Central to achieving this mission is our people-first philosophy.We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.
We equip all our staff members to live well-rounded, healthy lives.Most recently, Amgen added benefits for transgender employees and continues to pride itself on industry-leading, family-friendly offerings for families of all compositions.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.#J-18808-Ljbffr
