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EMD Serono, Inc. · 1 day ago

Director, Translational Research Lead, Immunology & Inflammation

Billerica, MA

Full-time

Onsite

Director/Executive

10+ years exp

EMD Serono, Inc. is a global leader in healthcare and life sciences, dedicated to innovating solutions that improve lives. The Director, Translational Research Lead, Immunology & Inflammation will bridge nonclinical research and clinical development, facilitating the translation of scientific discoveries into therapeutic solutions while supporting the program's development strategy.

BiotechnologyHealth CareHealth Diagnostics

Work & Life Balance

No H1B

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 Diligence of external opportunities

Qualification

PhD in ImmunologyTranslational ResearchClinical Trial ProcessesRegulatory GuidelinesWriting Regulatory DocumentsCollaboration with PartnersThought LeadershipTranslating Scientific InformationStrategic ThinkingEffective CommunicationLeadership Skills

Required

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