Position Code: 23061-19B
The Developmental Sciences Department is dedicated to strategies that bridge preclinical research and clinical development. Reporting to the CMO, this position will lead a team of scientists and/or physicians in defining and implementing translational initiatives. The incumbent will work cross-functionally to establish and implement research collaborations with other functional areas within the Company including clinical pharmacology, predictive biomarkers, pharmacodynamic biomarkers, and pharmacovigilance. This work will impact project level decision making and will require effective communications across a broad range of constituencies.
- Work with Team members and key partner functions (including Regulatory, Commercial, Nonclinical Development, etc.) to define biomarker strategies
- Oversee the discovery and development of development and provide guidance to potential partners for co-development of companion diagnostics
- Collaborate with colleagues in research and other departments to advance internal research and early development projects
- Manage, mentor, advise and foster the career development of a diverse group of development sciences team professionals
- Contribute to the Translational Medicine Team’s mission to understand the mechanism(s) of action
- Provide Translational Medicine support to partner functions; this may include providing input into clinical protocols, informed consents, sample collection manuals, investigator brochures and regulatory documents; helping to resolve biomarker-related questions from regulatory agencies; reviewing and interpreting clinical study outcomes, and overseeing the presentation of relevant results in clinical study reports and other study documents
- Maintain a strong understanding and awareness of emerging medical and diagnostic developments
- Develop models, both preclinical and clinical, to ensure robust decision making on developability of drug molecules in various therapeutic areas of interest
- Design proof of concept studies and full development for various therapeutic area programs
- Contribute to and review the clinical section of documents including, but not limited to, Protocols, the Investigator Brochure (IB), Case Report Forms (CRFs), Annual IND Safety Updates/EU Annual Reports, Clinical Study Reports, patient narratives, and submission related documents such as the Clinical Summary of Efficacy and Safety and the Clinical Overview
Education & Experience
- A minimum of an M.D. or Ph.D. with at least 10 years drug development experience in a biopharmaceutical environment
- Demonstrated experience in development, implementation and execution of clinical development strategies for novel drug candidates, from preclinical development through clinical proof-of-concept
- Successful track record with biomarkers in the clinical space including development and implementation of biomarker strategies required
- Hands-on experience establishing clinical, molecular and cellular diagnostics
- Working knowledge of GCP and FDA regulations
- Advanced knowledge of immune-oncology and emerging therapies in oncology.
- Detail-oriented with the drive and ability to prioritize workload with limited supervision
- Strong interpersonal skills and the ability to function in a team environment
- Excellent written communication and oral presentation skills
- Phase 3 clinical development experience desired
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to [email protected].