A career with EMD Serono is an ongoing journey of discovery: our 51,000 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 Head of Experimental Medicine is a strategic, scientific and clinical role, driving experimental and mechanistic medicine capabilities, thereby to drive the translation of assets from research into development. The incumbent will enable a ‘bench-to-bedside and bedside-to-bench’ approach in a highly collaborative fashion with other relevant R&D functions. This will create a data-driven, in-depth scientific culture, capable of researching, developing and commercializing innovative new medicines for patients.
- Furthermore, the role holder will be accountable ensuring alignment of the biomarker strategy with the needs of clinical development and submission.
- The role encompasses the creation and curation of the company’s brand around Experimental Medicine within diverse global clinical and scientific therapeutic communities and will require active engagement with external bodies engaged in the regulation and delivery of healthcare advancing the company’s activities and visibility within this arena.
- Contribute to the strategy for a biomarker-based patient selection across the related therapeutic areas together with the clinical development under the leadership of the TIP. This will involve working with stakeholders to ensure the optimal application of less-invasive, longitudinal, high-throughput, multi-dimensional to increase the likelihood of a successful drug development with well-defined Go/No Go-criteria
- Oversees, design and contribute to the interpretation methodological studies (Phase 0), clinical biomarker studies and proof of mechanism/experimental medicine studies assigned to the department.
- Contributes to design of proof of concept studies, and, if applicable, medical device studies
- Contributes to and reviews clinical sections of documents including, but not limited to, Protocols, the Investigator Brochure (IB), Clinical Study Reports, patient narratives, and submission related documents
- Lead clinical R&D efforts involving reverse translational research in close collaboration with TIP with the bioinformatic group and quantitative pharmacology.
- Propose new concept and drug target via Bioinformatic group and Exp. Medicine associates
- Work to drive the adoption of cutting-edge biomarker technology platforms and balance this with discovery and clinical research needs.
- Attends/presents at Investigator Meetings, Scientific Advisory Boards and health authority meetings
- Leverages CROs with GCO as well as academic collaborations to effectively deliver on program goals.
- Establish and maintain strong relationships with key opinion leaders in the respective therapeutic areas with an emphasis on building active relationships with clinical centers highly competent for Expl. Medicine research and early development.
- Responsible to review and give advice on licensing opportunities as assigned by Translational Medicine.
- Represent the Expl. Medicine as a SME at senior governance committees
- Potential to lead large critical cross-functional improvement projects in the area of experimental and mechanistic medicine, building change management and communication plans aligned with the overall R&D strategy
- Ensures the long-term success of the company by driving the successful transition of high-quality candidate drugs into pivotal trials from research into an early clinical proof of concept.
- Facilitates important learning from the clinical data (bedside) back into research (bench side).
- Represents the company at internal and external committees/bodies to build the scientific reputation of the company with respect to Exp. Medicine
Who You Are:
- MD or PhD degree
- Board certificate specialization in relevant medical field is a plus
- Fluent in written and spoken English
- Minimum 15+ years of significant contribution to early clinical development.
- Proven track-record of a leading role in translational medicine in a relevant discipline
- Demonstrated experience in cellular biomarker analysis or protein-based biomarker analysis, or molecular BM analysis, designing exp. medicine studies and quantitative sciences e.g bioinformatics
- Experience of contribution to global project teams
- Strong understanding of the operational considerations in executing experimental and mechanistic medicine studies
- Possesses a large external network in translational medicine at least in one core area.
- Sound knowledge of the pharmaceutical business (market and competitors) and trends in the industry.
- Position may require both domestic and international travel up to 30% of 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 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.