Global Safety Medical Director Immuno-oncology
Global Safety Medical Director Immuno-oncology
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$ 319267 - 319267
1 Vacancy
Job Description
Career Category
SafetyJob Description
Join Amgens Mission of Serving Patients
At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.
Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 awardwinning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Safety Medical Director
What you will do
Lets do this. Lets change the world. In this vital role you will serve as the safety expert of the assigned product(s) within the Rare Disease portfolio.
You will establish the strategy direction and priorities of pharmacovigilance activities and are accountable for the overall safety profile and all productrelated decisions and deliverables for assigned products.
You will also lead the Safety Analysis Team (SAT) Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC).
Serve as a member of the Evidence Generation Team and other relevant crossfunctional teams and will be assigned as delegated for the Therapeutic Area Head (TAH).
Work in a fastpaced environment with a dynamic team of safety physicians and scientists dedicated to bringing important therapies to patients in need.
Key activities:
- Validate safety signals and lead safety signal assessments
- Develop and maintain Core Safety Information (core data sheet core risks in informed consent forms etc.
- Prepare/review core and regional risk management plans including additional risk minimization measures
- Prepare/review safety sections of periodic aggregate reports
- Provide safety input to protocols statistical analysis plans and clinical study reports
- Prepare/review safety sections of new drug applications and other regulatory filings
- Serve as safety expert on Evidence Generation Team for assigned products
- Inspection Readiness
- Domestic and International travel up to 10
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:
- Product safety in the bio/pharmaceutical industry or regulatory agency
- Expertise in Rare Disease therapeutic area or clinical training.
- Experience with marketed product safety; risk management
- Experience with phase 13 clinical trials safety assessments and analyses
- Drug Submission experience
- Leadership experience of the safety profile of products assigned with crossfunctional team members.
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 wellbeing. From our competitive benefits to our collaborative culture well 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 salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans
- Flexible work models including remote and hybrid work arrangements where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen
In any materials you submit you may redact or remove ageidentifying 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.
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.
.Salary Range
243245.00 USD 319267.00 USDRequired Experience:
Exec
Employment Type
Full-Time
