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 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.
Your role: The Director of Signal Detection and Benefit Risk Assessment is accountable for the execution of signal detection and benefit-risk thinking and methodology. This is achieved through helping drug development teams to collect relevant information to build up a structured benefit risk approach that help increase the competitive advantage of the company products throughout products’ life cycle.
This adds value through enhanced and timely understanding of where our products fit on the map as compared to other products in the market, in effect leading to decision-making earlier in clinical development with better focused target indications and populations as well as increasing the chances for timely product approvals. The person will be an in-house expert for the execution of various qualitative and quantitative benefit-risk assessment methodologies, existing as well as emerging.
Who you are:
- Bachelor’s degree with 10 plus years of experience, Master’s degree with 5 plus years of experience, and PhD with 3 plus years required.
- MD with MPH, PhD (epidemiology/statistics), PharmD, RN/BSN, or MPH, with 5 years of industry experience in pharmacovigilance experience (including risk management activities and experience in Benefit-Risk evaluation) strongly preferred
- Advanced knowledge in epidemiology and statistics is a plus.
- Experience in providing tailored training on Benefit-Risk methodologies and approaches to stakeholders including safety staff, statisticians, clinicians, and early phase scientists.
- Experience in benefit-risk assessments for new product developments and post-marketing safety deliverables such as periodic benefit risk evaluation report (PBRER).
- Recognized external profile in pharmacovigilance, therapeutic or clinical development networks (e.g. speaker at professional conferences and workshops, representation on external policy-making or educational groups).
- Membership of the Innovative Medicine Initiative (IMI) is a plus.
- Experience in vendor management for outsourced activities, including development of scope of work, project milestones, timelines, deliverables, and budgets.
- Position requires both domestic and international travel up to 15% of the time.
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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.