Goldfinch Bio

Job Title: Director, Clinical Science

Job Number: 20953

Location: Cambridge, MA

Job Description

Goldfinch Bio is seeking a highly motivated and qualified individual for the position of Director, Clinical Sciences (AMD/SCS).  This person reports to the Vice President of Translational and Clinical Nephrology with matrixed responsibilities to an inter-disciplinary team. They are responsible for translating biologically validated genetic discoveries into precision medicines for patients with kidney disease. Goldfinch Bio believes genetic insights are critical to discovering and developing drugs which will safely provide clinically-relevant benefits desired by patients. The AMD/SCS is the key stakeholder of each of our program’s clinical development plan and contributor to its operational success. The AMD/SCS supports the collection, review and interpretation of clinical, genetic and biological data from Goldfinch Bio’s drug-discovery engine (the Kidney Genome AtlasÔ). 

Responsibilities

Job Responsibilities Include:

  • Responsible for development and implementation of clinical development plans across multiple drug candidates and indications
  • Conducts research literature reviews in support of innovative, efficient and adaptable clinical programs suitable for regulatory submission and supporting the value of our innovations
  • Supports team (including biometrics, operations, safety) by providing clinical guidance toward the design, development, and conduct of Phase 1-3 clinical trial protocols
  • Assists in determining and optimizing subject inclusion/exclusion criteria, and endpoints appropriate to the trials’ customer (patient, prescriber, regulator, payor) oriented objectives
  • Selects safety and efficacy measures based on available data and guides selection of appropriate data collection parameters
  • Plans purposeful acquisition of high-quality data guided by the principles of Goldfinch Bio’s product engine: the integration of clinical, genomic and biologic data toward developing precision medicines for patients with kidney disease
  • Assesses and interprets clinical safety and efficacy data and guides 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.
  • Supervises 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
  • Interprets and reports 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
  • Builds strong KOL, Principal Investigator and regulator relationships
  • Serves as Goldfinch Bio’s representative to Principal Investigators, Sub-investigators and their site staff ensuring optimal sponsor-site relationships including at Investigator Meetings and clinical site visits
  • Participates in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) and responds to regulators’ questions as needed

Required Skills

Qualifications/Experience:

  • Advanced clinically- and research-oriented degree and training (life-sciences PhD, PharmD Masters degree at a minimum, research-experienced MD or MD/PhD training preferred) 
  • At least 3 years of experience in a comparable clinical development role at a pharmaceutical or biologics-oriented Sponsor company or organization
  • 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 of subjects and to maintain confidentiality of data
  • Ability to travel up to 25%

 

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