Senior Medical Director, Global Safety- Obesity and related conditions

Amgen • Thousand Oaks, CA

1d

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Senior Medical Director, Global Safety What you will do Let’s do this. Let’s change the world. In this vital role you will establish the strategy, direction, and priorities of global safety activities and are accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

Requirements

• Doctorate degree and 5 years of Global Drug Safety experience OR Master’s degree and 9 years of Global Drug Safety experience OR Bachelor’s degree and 11 years of Global Drug Safety experience
• In addition to meeting at least one of the above requirements, you must have at least 5 years of experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
• Your managerial experience may run concurrently with the required technical experience referenced above.

Nice To Haves

• Fluent knowledge of the Obesity and related condition landscape (either by experience or individual study)
• Medical Doctorate and board certification.
• Adaptable to varied matrix and ways of working in a fast-paced environment that requires fast turnaround for key deliverables
• Capable of working under high pressured environments
• Experience in people management

Responsibilities

• Serve as the safety expert of the assigned product(s) and or setting the strategy, direction, and priorities of pharmacovigilance activities in the dynamic field of obesity and related conditions at Amgen which includes insight into safety strategy as well as medical assessment of safety concerns for internal assets as well as summary of competitive obesity landscape and related data (e.g. competitive labels, publications, AERS and FAERs databases and the like).
• Accountable for Amgen position on safety concerns unique to the obesity franchise and capable of presenting these positions to senior leadership
• Manage Safety Directors, Associate Safety Directors, and/or Global Safety Professionals.
• Accountable for providing strategic oversight, direction and authorship for all major regulatory safety submissions, 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 datasheet, 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 asset(s) across all indications in the portfolio including early development programs from pre-clinical, FIH and Ph1-3 studies as well as post-approval studies.
• 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 for evidence generation, data review and regulatory documents and responses.
• Capable of independently authoring concise presentations summarizing safety concerns in the Amgen franchise with supporting data of topics in Obesity literature, competitive landscape and mitigation strategies
• 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.

Benefits

• A 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
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees