Goldfinch Bio

Job Title: Director, Clinical Science

Job Number: 22662

Location: Cambridge, MA

Job Description

Goldfinch Bio is seeking a highly motivated and qualified individual for the position of Director, Clinical Science. This role reports to the Vice President of Translational and Clinical Nephrology and has matrixed responsibilities to a cross-functional team. This role will be primarily responsible for the timely development and implementation of clinical development strategy across multiple drug candidates and indications, as well as the interpretation of clinical study results. The Director, Clinical Science will act as a primary driver for each of our program’s clinical development plans and contribute significantly to their operational successes.

Responsibilities

  • Development and implementation of clinical development plans across multiple drug candidates and indications
  • Conducting research literature reviews in support of innovative, efficient and adaptable clinical programs suitable for regulatory submission and supporting the value of our innovations
  • Supporting the clinical team (including biometrics, operations, safety) by providing clinical guidance toward the design, development, and conduct of Phase 1-3 clinical trial protocols
  • Assisting in determining and optimizing subject inclusion/exclusion criteria, and endpoints appropriate to the trials’ customer (patient, prescriber, regulator, payor) oriented objectives
  • Selecting safety and efficacy measures based on available data and guiding selection of appropriate data collection parameters
  • Assessing and interpreting clinical safety and efficacy data and guiding medical writer’s preparation of sections of protocols, clinical study reports, clinical sections of INDs, Core Safety Data Sheets, Investigator Brochures, and other clinical documents
  • Supervising the assigned medical monitors toward safe and GCP-compliant implementation of clinical trials in collaboration with responsible Principal Investigators, Institutional Review Boards/Ethics Committees and Independent Data Monitoring and Endpoint Adjudication Committees
  • Interpreting and reporting the results of the research, including presentation to: (internal development teams; external therapeutic area experts, partners, investors and customers; global audiences, through publications and lectures)
  • Building strong KOL, Principal Investigator and regulator relationships
  • Serving as Goldfinch Bio’s representative to Principle Investigators, Sub-investigators and their site staff ensuring optimal sponsor-site relationships including at Investigator Meetings and clinical site visits
  • Participating in the preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) and responds to regulators’ questions as needed

Required Skills

Qualifications/Experience:

  • Minimum of a PhD, PharmD or equivalent. MD or MD/PhD training preferred. Advanced clinical research-focused background and training
  • At least 3 years of experience in a comparable clinical development role at a sponsor biopharma company or organization
  • Experience working in a matrix or direct personnel and project management experience preferred
  • Ability to thrive in a fast-paced, innovative work environment while remaining flexible, proactive, resourceful and efficient
  • A working knowledge of early drug development principles, including: application of medicinal chemistry, translational biology, pre-clinical toxicology and ADME and the latest standards for early clinical safety testing and development is required
  • Robust experience with, or understanding of, early-stage clinical development programs, including proof-of-concept, Phase 1, Phase 2, and through later development
  • Rare disease and First in Human Studies experience preferred
  • Nephrology Therapeutic Area experience strongly preferred
  • Excellent verbal, written and presentation communication skills are essential
  • Skilled in bidirectional translational medicine (i.e. bringing bench science discoveries into the clinic and clinical learnings back to the lab)
  • An innate understanding biopharmaceutical business strategy: i.e. the interdependence of scientific discovery and entrepreneurial business development
  • Good knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
  • Knowledge of applicable HHS and FDA standards for adequate provisions to protect the privacy ofsubjects and to maintain confidentiality of data
  • Ability to travel up to 25%

 

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