Director / Senior Director, Pharmacology

SUMMARY: 

Generation Bio seeks an energetic and highly motivated (Sr) Director to join the preclinical team and lead our pharmacology function. This highly visible position will lead a team of scientists to drive platform and translational pharmacology research. This role will develop and execute a pre-clinical strategy to advance our ctLNP platform, and work closely with our discovery research and program teams to develop translational models and bioassays to advance our pipeline of T cell siRNA programs.

The ideal candidate will have a strong background in research and development of immune-modulating therapies, with experience developing bioassays and biomarkers to characterize drug pharmacology in early development. The successful candidate will move seamlessly between managing in-vivo studies as well as demonstrating a strong commitment to leading and developing a team of scientists performing lab-based work to develop animal models, biomarkers, and new bioassays.  The position will partner closely with cross-functional colleagues across Research, Analytical Development, and Non-Clinical Development to deliver on the company objectives. 

 
RESPONSIBILITIES:  

• Build, support, and lead a team of scientists to design and execute mechanistic and translational studies as well as develop assays to characterize siRNA mediated inhibition and associated immunological effects in T-cells.
• Develop, characterize, and evaluate animal disease models.
• Work with non-clinical development and regulatory teams to optimize, validate and transfer key bioassays for IND-enabling and clinical studies
• Collaborate with internal and external partners to provide strategic pharmacology guidance, plan, and execute studies to support preclinical and clinical drug development.
• Serve as a subject matter expert to project teams via functional representation, and advise on regulatory submissions, and author regulatory documents from FIH through registrational filing.
• Interface externally with CRO(s), collaborators, and potential research partners.
• Summarize studies in written reports and oral presentations.
• Review literature to identify relevant technologies and models.
• Participate in due diligence and business development activities as needed.

QUALIFICATIONS:  

• Ph.D. in Pharmacology, Immunology, Molecular/Cell Biology, or related field, with a minimum of 7 years of relevant experience. M.Sc. with a minimum of 10 years relevant experience, industry experience is required 
• Experience in autoimmune diseases and T-cell biology or a background in tumor immunology.
• Demonstrated leadership capabilities and the ability to lead and motivate team members and reinforces a positive and inclusive team culture that encourages growth and development.
• Proven ability to develop strong relationships with internal and external partners to deliver on key objectives while nurturing a collaborative, innovative, and inclusive work environment.
• Excellent lab technique and the ability to work independently to design experiments and analyze, interpret, and present data.
• Proficient in protein and DNA/RNA detection and quantification (ELISA, western, RT-qPCR), cell-based imaging/flow cytometry (IHC, FACS), and activity assays (T-cell activation/killing assays, co-culture).
• Proficient in in vivo/ex vivo sample and tissue preparation for flow cytometry/IHC based characterization.
• Proactive thinking and ability to multi-task to support multiple projects across platform and disease biology pharmacology.
• Demonstrated ability to analyze complex situations, identify critical issues, and develop proactive strategic solutions.
• Experience authoring regulatory submissions and responses preferred.
• Ability to work in a highly collaborative, team-based environment, with the ability to influence change across different stakeholder groups to drive business objectives.
• Excellent written and verbal communication skills.

POSITION: Full-Time, Exempt