Director / Senior Director, Pharmacology

Director / Senior Director, Pharmacology Company Address : 301 Binney Street, 4th Floor, Cambridge, Massachusetts 02142, USAbout Generation Bio Generation Bio is innovating genetic medicines to provide durable, redosable treatments for people living with rare and prevalent diseases. The company’s non-viral platform incorporates a novel DNA construct called closed-ended DNA, or ceDNA; a unique cell-targeted lipid nanoparticle delivery system, or ctLNP; and a highly scalable capsid-free manufacturing process that uses its proprietary cell-free rapid enzymatic synthesis, or RES, to produce ceDNA.Job Description Generation Bio is a biotechnology company changing what is possible for people living with T cell-driven autoimmune diseases. The company is developing novel therapeutics leveraging its T cell selective cell-targeted lipid nanoparticle (ctLNP) to deliver siRNA in vivo, enabling modulation of T cell activity that causes inflammation and auto-reactive tissue destruction. By selectively modulating T cells that drive disease pathology, ctLNP-siRNA therapeutics could potently block target function with sequence-level specificity while sparing the broader immune system. This potent new modality is designed to reach targets that are poorly drugged by other approaches, opening a broad indication space of T cell-driven autoimmune diseases.We are a thriving, collaborative, creative community of 100 people with diverse talents, beliefs, and experiences headquartered in Cambridge, Massachusetts.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 reinforce 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, ExemptEEOC Statement : Generation Bio believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race (to include traits historically associated with race including, but not limited to, hair texture, hair type, hair length, and protective hairstyles such as braids, locks, twists, hair coverings, and Bantu knots), color, gender, religion, national origin, gender identity, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Generation Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.#J-18808-Ljbffr