Director, Translational Research Lead, Immunology & Inflammation

The businesses of Merck KGaA, Darmstadt, Germany•Billerica, MA

About The Position

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: The successful candidate will play a pivotal role in bridging nonclinical research and clinical development, facilitating the translation of scientific discoveries into innovative therapeutic solutions. The Translational Research Lead will determine key research activities and priorities to support the program's development strategy, ensuring effective knowledge sharing and transfer between the Discovery Project Team (DPT) and the Global Project Team (GPT).

Requirements

PhD in immunology, cellular/ molecular biology, with at least 10 years of industry experience in Immunology and Inflammation (I&I)
Proven experience in early clinical and translational research in I&I (eg, dermatology, rheumatology) within the pharmaceutical or biotechnology industry.
Strong understanding of nonclinical and clinical trial processes, regulatory guidelines, and drug development.
Experience in writing the nonclinical sections for regulatory documents
Experience collaborating and managing external partners, including academic and Contract Research Organizations

Nice To Haves

Strategic thinking to support program vision and strategy development.
Effective communication skills for cross-functional & cross- hierarchical engagement.
Leadership skills to guide the Research Team.
Demonstrated thought leadership within research.
Comprehensive understanding of previous work conducted on the program.
Ability to translate complex scientific information for broader audiences.
Prioritize overall program success with an enterprise-wide perspective.

Responsibilities

Provide research and nonclinical expertise to support the Global Program Steering Team (PST) in developing the program vision and strategy.
Act as the Research Lead for the non-clinical/research team.
Support disease/target biology and interpret data from nonclinical and clinical studies to conceive and execute novel scientific research internally or externally to support advancement of the program strategy.
Maintain close interactions with Discovery Project Teams, PST members, PST sub teams and Global Product Heads (GPHs) to ensure transparency and transfer of program-relevant nonclinical knowledge, enabling a seamless transition from discovery phase to clinical development
Coordinate the writing of nonclinical reports/sections within a regulatory framework (eg, IND).
Analyze and contextualize nonclinical/translational data from competitors and support local teams in strategizing against potential competitive products.
Support internal and external communication campaigns related to research.
Drive nonclinical activities and contribute to the Integrated Evidence Plan (IEP) as a member of the Program Steering Team.
Maintain accountability and escalate activities and decisions impacting the overall program IEP, timeline, and budget to the PST/GPH.
Coordinate communication and decision-making on research-related topics within and outside of the GPT.
Seek engagement with Key Opinion Leaders (KOLs) regarding nonclinical/translational data
Conduct Due Dilligence of external opportunities.