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Director/Senior Director (Translational Medicine Lead), Translational Medicine

Company: Finch Therapeutics
Location: Somerville
Posted on: January 15, 2022

Job Description:

Director/Senior Director (Translational Medicine Lead), Translational Medicine Somerville , Massachusetts , United States - Translational Medicine - Full-time Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs. - With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch's lead candidate, CP101, is in late-stage clinical development for recurrent -C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn's disease, respectively. Position Summary Finch Therapeutics is seeking a member of the Translational Medicine Group focusing on our -first in human (FIH), proof of concept (POC), Ph II-III investigational studies in various diseases. The ideal candidate for this position will have experience in developing strategy and implementation of biomarkers and relevant translational medicine activities. The incumbent will serve as a primary contributor to Finch's Translational Medicine team, working closely with the Clinical Development and Research organizations to develop, validate and implement biomarkers in clinical studies. - This role embraces the principles of a translational medicine mindset, with a focus on scientific rigor and operational excellence. The ideal candidate will have a passionate desire to help transform current treatment paradigms while working in an innovative and fast-paced company environment. - Responsibilities

  • Manage the design and implementation of biomarker analysis in clinical trials, ensuring operational execution by partnering with biomarker labs and data management according to GCP guidelines.
  • Work with and interface closely with a cross functional team (including Molecular Microbiology, Analytical Development, Quality, Regulatory, and Clinical Development) to ensure early definition of, and agreement on TM strategy and workplans in line with the overall program, clinical development and regulatory requirement.
  • Partner with the Research Team to address translational medicine questions to advance clinical program(s) and elucidate Mechanism(s) of Action through preclinical in vivo studies and clinical trials.
  • Responsibility for the biomarker aspect of clinical protocol design and writing, as well as authoring the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, study procedural manuals and consent forms, program documents, regulatory submissions and responses (INDs/CTAs) in collaboration with the clinical team.
  • Co-author, assist and support the development of publications, abstracts, and presentations according to the publication strategy.
  • Interact with clinical sites and partners to ensure accurate and appropriate clinical sample collection to support the biomarker strategy.
  • Lead efforts for clinical studies biomarker data generation, interpretation, and communication. Oversee implementation plans for clinical sample operations, management, and analysis according to GCP guidelines.
  • Partner with biostatisticians and bioanalytical laboratories (Vendors and internal partner(s)) to establish biomarker analysis plans to ensure delivery of high-quality data to support analysis, interpretation and reports of clinical biomarkers for internal decision-making and Health Authority submissions.
  • Represent Translational Medicine in cross-functional project teams and prepare data presentations and relevant updates.
  • Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas. Qualifications
    • PhD, PharmD, or MSc, with minimum 7 years of relevant work experience, including a minimum of 5 years in translational medicine and biomarker strategies during clinical stages of drug development.
    • Strong scientific background in a relevant field (Molecular Biology, Microbiology, Biochemistry, Immunology, Autoimmunity, Infectious Diseases, Neuroscience, other).
    • Experience managing CROs in the implementation of biomarker strategies and working knowledge of GxP guidelines (GCP, GMP).
    • Good understanding of the biopharmaceutical environment, drug development relevant areas of biostatistics, regulatory, clinical pharmacology and new biomarker identification and validation framework.
    • Knowledge of biomarker development and implementation process in early stage of drug development to support clinical assay development, qualification and validation framework for mechanism of action, proof of biologic activity, proof of concept, patient stratification and response prediction markers. Experience with the development of precision medicine approaches as laboratory developed tests (LDT) or companion diagnostics (CDx) is a plus.
    • Strong interpersonal skills and demonstrated ability to establishing effective collaborative relationships with internal and external teams and work successfully in a fast-paced, team-oriented environment.
    • Strong oral, written and presentations communications skills with the ability to represent the Translational Medicine within the organization. More About Finch Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we'll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
      • Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer generous paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
      • We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team. *Only facility-dependent employees are working on-site in Somerville until further notice. Equal Opportunity Employer We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.

Keywords: Finch Therapeutics, Somerville , Director/Senior Director (Translational Medicine Lead), Translational Medicine, Executive , Somerville, Massachusetts

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