Director, Translational Research Lead, Neuroscience & Immunology

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

About The Position

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 neuro-immunology or immunology, with at least 10 years of industry experience in neuro-immunology
Proven experience in early clinical and translational research in I&I (eg, ischemia-reperfusion injury, ischemic stroke) 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.