Director or Senior Director, Translational Medicine (Bioanalytical)
Location: Somerville, Massachusetts, 02143, United States
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.
Finch Therapeutics is seeking a member of the Translational Medicine Group focusing on assay development, qualification/validation of the methods for our first in human (FIH), proof of concept (POC), Ph I-III investigational studies in various diseases. The ideal candidate for this position will have experience in bioanalytical methods development, qualification and validation across technologies. The incumbent will serve as a primary contributor to Finch’s Translational Medicine team, working closely with the Translational Medicine Leads, Research and Clinical Development organizations to develop 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 small-company environment.
- Oversee the design, development, qualification/validation, and implementation of the quality pharmacokinetic, pharmacodynamic, pharmacogenomic, patient selection (where appropriate), biomarker assays to support the advancement of Finch preclinical programs into the clinic.
- Assist in managing the 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 develop novel assays across technologies.
- Assist in all methods’ relevant aspects of biomarker sections including IND applications and clinical Reports, study procedural manuals, 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.
- Contribute to the clinical studies biomarker data generation, interpretation, and communication. Review and analyze assay data for quality assurance and consistency, oversee implementation plans for clinical sample operations, management, and analysis according to GCP guidelines.
- Partner with biostatisticians and bioanalytical laboratories (Vendors) 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.
- Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas.
- PhD, PharmD, or MSc, with minimum 10 years of relevant work experience, including a minimum of 5 years in translational medicine and biomarker methods development during clinical stages of drug development.
- Experience in bioanalytical assay development and methods qualification to support PK and biomarkers including technology transfer, implementation at CROs including quality oversight is a strong plus.
- Strong scientific background in a relevant field (Molecular Biology, Microbiology, Biochemistry, Immunology, Autoimmunity, Infectious Diseases, Neuroscience, other).
- Good understanding of the biopharmaceutical environment, drug development relevant areas of biostatistics, new biomarker identification and validation framework, regulatory and clinical pharmacology.
- Knowledge of biomarker development and implementation process in early stage of drug development to support clinical assay development, qualification and validation for mechanism of action, proof of biologic activity, proof of concept, patient stratification and response prediction markers. Relevant skills include understanding of relevant techniques such as PCR, NGS, LC-MS/(MS), immunoassays, gene expression, etc. Experience with the development of precision medicine approaches as laboratory developed tests (LDT) or companion diagnostics (CDx) is a plus.
- Experience and working knowledge of GxP guidelines (GCP, GMP, GLP) as well as contracting with, overseeing and managing external vendors to implement bioanalytical assay development and ensure execution excellence and data analysis integrating different data modalities in support of clinical studies.
- 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 discretionary and flexible paid time off policies. Should you choose to start or expand 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, fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox.. 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.
*Though only facility-dependent employees are currently working onsite in Somerville, Ma, we all plan to return to the office when it’s safe to do so.
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.