- Serve as the safety expert of the assigned product(s) and or setting the strategy, direction, and priorities of pharmacovigilance activities.
- Manage Medical Directors, Associate Med Directors, and/or Global Safety Physicians (GSP).
- Accountable for providing strategic oversight, direction for all major regulatory safety responses or strategic deliverables including but not exclusive to Safety sections of NDA submissions, RMPs, PSURs, PBRERs, DSURs, DILs.
- Accountable for the Development and maintenance of core reference safety information (e.g., Development Core Safety Information [DCSI], Core safety information portions of Core Data Sheet [CDS])
- Lead the safety strategy and Benefit/Risk Management Process for assigned portfolio.
- Contribute to the strategic discussion on clinical trial design and developing core clinical trial related documents including but not limited to Informed Consent (ICF), Protocol, and Investigator Brochure (IB)
- Safety representative to cross functional meetings in providing strategic input.
- Act as Chair or participate in safety governance meetings per Standard Operating Procedures and Manuals for assigned products.
- Lead and contribute to functional projects for process improvement as needed.
- Can act as delegate for the TAH (Therapeutic Area Head) as needed.
- Experience in Oncology
- Experience in people management
- 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
- Flexible work models, including remote work arrangements, where possible
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Sr Director Global Safety, Oncology - Washington, United States - BioSpace
Description
Job DetailsHOW MIGHT YOU DEFY IMAGINATION?
If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.
Senior Director Global Safety
Live
What you will do
Lets do this. Lets change the world. In this vital role you will establish the strategy, direction, and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
MD or DO degree from an accredited medical school
AND
Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Preferred Qualifications:
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 expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $275,636.00 to $335, Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
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:
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
