Goldfinch Bio

Job Title: Medical Director, Clinical Development

Job Number: 23822

Location: Cambridge, MA

Job Description

Goldfinch Bio seeks a highly motivated and qualified individual for the position of Medical Director, Clinical Development. 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 plans across multiple drug candidates and indications, as well as the interpretation of clinical study results. The Medical Director, Clinical Development 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, indications and phases
  • Leverage his/her comprehensive understanding of the drug development process in early and late stage
  • Work as part of an integrated team
  • Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports’
  • Collaborate with others to write protocols, investigator brochures, regulatory filings and present data in a concise, consistent, and compelling manner
  • Provide support to advisory boards, consultant meetings and investigator meetings (including preparation and delivery of presentations)
  • Collaborate with the clinical development team on the review, analysis, and interpretation of clinical and non-clinical study data
  • Responsibilities also include adverse event reporting and safety responsibilities monitoring
  • Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products
  • Ensures the development and implementation of clinical program strategy and directs those systems and programs in order to meet Company goals and objective
  •  Participating in the preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) and responds to regulators’ questions as needed

Required Skills

  • MD or MD/PhD training preferred. Minimum of a PhD, PharmD or equivalent
  • Advanced clinical research-focused background and training
  • Minimum of 3 years of experience in a comparable clinical development role at a sponsor biopharma company or organization
  • Nephrology Therapeutic Area experience strongly preferred
  • Experience working in matrix or direct personnel
  • Ability to thrive in a fast-paced, innovative work environment while remaining flexible, proactive, resourceful and efficient
  • Robust experience with, or understanding of early-stage clinical development programs, including proof-of-concept, Phase 1, Phase 2, and through later development
  • 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 of subjects and to maintain confidentiality of data
  • Ability to travel up to 25%

 

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