A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
The focus of GPS Innovation is on providing integrated strategic safety expertise to our pipeline products.
The role of the Medical Director, GPS Innovation is to ensure the delivery of effective proactive medical safety strategies for the assigned development compounds or defined indications including safety risk management and benefit-risk evaluation.
The role includes the identification and evaluation of safety signals, the definition, implementation and evaluation of risk mitigation strategies, preparation of risk management plans, periodic safety reports, and other regulatory documents as well as the delivery of medical safety input to clinical development activities.
Who you are:
- Bachelor’s degree with 10+ years of experience, master’s degree with 5+ years of experience, or PhD degree with 3+ years required
- Medical degree plus accredited residency preferred
- Accredited fellowship or clinical experience in relevant therapeutic area specialty is preferred
- Broad industry experience and 5 years of medical experience as a physician preferably in clinical development and pharmacovigilance strongly preferred
- Mastery of global regulatory requirements for drug safety and pharmacovigilance
- Clinical knowledge of therapeutic area, patient populations and drug class
- Proficiency in signal detection and evaluation as well as benefit-risk management
- Great at communication (written and oral presentations), data analysis, and scientific leadership
Position requires both domestic and international travel up to 15% of time.
This role can be located at our Rockland or Billerica, MA, location.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.