Senior Medical Director, Global Safety- Obesity and related conditions

Amgen • Full-time • Remote (United States) • $292.55k - $395.80k / year • 20h ago

oin 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.

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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The drug and patient safety professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 5 years of Global Drug Safety experience

Master’s degree and 9 years of Global Drug Safety experience

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.

Preferred Qualifications:

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

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. 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, based on eligibility, comprising of 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 that may include:

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. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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.

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