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.
Global Drug Safety Innovation provides integrated strategic medical and safety expertise to clinical development programs; performs active pharmacovigilance with rapid identification and analysis of safety signals, to define emerging drug safety profiles for assigned products and drive patient risk management.
The Senior Medical Director is the accountable individual who will drive a cross-discipline, matrixed team including, external specialized consultants, in the continuous management of the safety profile of an assigned portfolio of company’s products, setting the strategy and overseeing efficient signal detection, risk management, proactive risk minimization measures, and an ongoing evaluation of the benefit-risk profile of their product portfolio from pre-clinical development through the global approval and post-approval phases of drug development. This individual will lead the effective medical, analytical, technical and scientific review of the safety data collection, evaluation, and medical interpretation. The Senior Medical Director will be the lead spokesperson for communication of these safety data both internally within the company and externally with worldwide health authorities impacting the successful registration of the company‘s products globally. The role of the Senior Medical Director may include managing and mentoring other safety physicians within GDS PV Innovation.
The Senior Medical Director has a safety strategy leader role for a development compound/s with responsibility to:
- Lead the delivery of innovative, strategic safety expertise to ensure comprehensive, accurate and consistent safety medical assessments for assigned products with accurate and timely reporting of these data within Merck Biopharma/EMD Serono and to global health authorities
- Identify key safety issues associated with their portfolio of products
- Establish the medical safety strategic direction including appropriate escalation within the company in case of new significant safety signals or safety issues
- Deliver high quality safety contributions to the overall Clinical Development Plan, making sure that the Clinical Development Plan adequately addresses safety risks for each of the products in their portfolio
- Work with commercial colleagues to drive the development of the medical safety portion of the Merck Biopharma/EMD Serono compound Target Product Profile
- Provide consistent high-quality representation of GDS on cross-functional teams such as the Global Product Teams, Clinical Development Teams, Submission Teams, so that safety considerations reliably inform project decision-making, and all clinical development safety requirements are met
- Drive the safety data management and communication, including medical review of individual cases, periodic safety reporting, and safety signal detection, evaluation and management based on medical judgment and clinical experience
- Produce high quality documents owned by GDS such as periodic safety reports, signal evaluation reports, and risk management plans; delivery of high quality contributions to other product- and trial-related documents including, IMPD, IB, DCSI/CCSI, Briefing Books, PIP, concept sheet, clinical trial protocol/report, ICF
- Deliver senior expert contributions to benefit-risk evaluations, and go/no-go decisions at critical development and life-cycle stages
- Provide leadership of the Emerging Safety Issue process according to the SOP, ensuring appropriate urgency in the provision of medical safety assessment for medical or quality alerts which might impact the benefit-risk of a product
- Represent GDS in submission teams and delivery of high quality safety contributions to submission documents such as Integrated Summary of Safety, Summary of Clinical Safety, and safety sections of Clinical Overview, 90/120 Day-Safety Update Report, labeling document, Risk Management Plan and REMS as appropriate
- Work independently to deliver high quality representation of GDS at meetings with external experts including, SMCs/IDMC members, regulatory authority meetings, interactions with external advisers or opinion leaders, and collaboration with colleagues from partnership companies for co-development or co-marketing
- Deliver the accurate and timely safety data for Global Response Documents, Publications, Press Releases, Q&As, and other communication documents
- Lead the safety review for Company Due Diligence activities
- Deliver defined medical safety requirements for clinical trials
- Operationally manage 3rd party vendors and contractors
- Manage the training and development of matrixed and direct reports (as assigned)
- Support successful project execution through effective budget and resource planning for their portfolio of products
Who You Are:
- MD required (or international equivalent)
- Accredited fellowship and/or clinical experience in relevant therapeutic area is strongly preferred
- 10+ years’ experience pharmaceutical/biotechnology industry experience in global drug safety especially analysis & interpretation based on data, science, and the disease being studied and experience including drug development (pharmaceuticals, biotech, CRO)
- 10+ years’ clinical experience as a physician and relevant drug safety and pharmacovigilance experience, including training
- Comprehensive mastery of global regulatory requirements for drug safety and pharmacovigilance
- Thorough clinical knowledge of therapeutic area, patient population, and drug class
- Proficiency in signal detection and evaluation
- Basic understanding of continuous Benefit Risk Assessment
- Prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
- Fluency in written and spoken English
- Ability for 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.