Associate Medical Director/Senior Clinical Scientist

Goldfinch Bio - Cambridge, MA (30+ days ago)


Goldfinch Bio is a biotechnology company that is singularly focused on discovering and developing precision therapies for patients with kidney disease. Just as the goldfinch has long been a symbol of healing and renewal and was a prominent figure of the Renaissance, Goldfinch Bio is leading a new age of therapeutic discovery to transform the treatment paradigm for people with kidney disease. Goldfinch was launched in 2016 by Third Rock Ventures, and is headquartered in Cambridge, Mass. For more information, please visit www.goldfinchbio.com. The Associate Medical Director/Senior Clinical Scientist (AMD/SCS) will be part of an inter-disciplinary team responsible for translating genetic discoveries into precision medicines for molecularly defined patient populations. The AMD/SCS will contribute to the development of clinical strategies and operational implementation of clinical programs. This role will also be responsible for data review and interpretation from a robust drug discovery engine and a growing patient registry to optimize clinical targets. Contribute to clinical development plans across multiple drug candidates and indications
Conduct research literature reviews to support clinical programs
Assist with the design, protocol writing, and conduct of Phase 1-3 clinical trials
Assist in determining subject inclusion/exclusion criteria, and appropriate endpoints
Select safety and activity measures and appropriate data collection parameters
Assess clinical safety and efficacy data, and write clinical study reports, clinical sections of INDs, sections of protocols, Investigator Brochures, and other clinical documents.
Participate in the interpretation and reporting of the results of the research
Present pre-clinical and clinical data to internal development teams and external therapeutic area experts
Build strong KOL, Principal Investigator relationships, with a focus on presenting pre-clinical and clinical data
Participate with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships including Investigator Meetings and clinical site visits
Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
Attend scientific conferences as needed Advanced degree (PhD or Pharm D required; MD preferred)
3-5 years experience in Clinical Scientist or Medical Director role at a Sponsor company in a development setting
A working knowledge of the key areas of early drug development, including chemistry, biology, toxicology and early clinical development is required
Robust understanding and experience with 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 and written communication skills are essential
Ability to apply translational medicine aspects going into the clinic and learning from the clinic back to the lab
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
A detailed understanding of overall strategic direction, interrelationships and business needs
Ability to travel up to 25%