Clinical Development Executive Director GI
Location: Cambridge, MA
Contact: Janene Cleary, firstname.lastname@example.org
Clinical Development Executive Director GI | Expanding Biopharmaceutical Company
This search is being conducted on behalf of our global biopharmaceutical client that is built around an innovative model for drug development that combines the operating efficiency of a small company with the funding of a large R&D organization. We seek an individual with Phase I/II experience in GI.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
- This company offers a unique business model that is very different from large pharma and the typical biotech.
- The environment is very entrepreneurial.
- One must Possess self-motivation, creativity and a willingness to take a “roll-up the sleeves”.
- Reports into the Chief Medical Officer.
Location: This company is located in the Cambridge, MA area.
HIGHLIGHTS OF RESPONSIBILITIES:
- Leads clinical programs in partnership with a Clinical Operations Lead of development assets from the IND-enabling stage through Phase 2 proof-of-concept.
- Designs and implements clinical research strategies and is accountable for the development and execution of clinical research programs for novel agents in a variety of therapeutic areas and disease states.
- Directs study design, protocol development and implementation of clinical studies.
- Defines in partnership with a Clinical Operations Lead clinical study parameters, deliverables, and resource needs.
- Reviews and evaluates clinical research results to inform development strategy, operational tactics and future marketability.
- Serves as the medical monitor for a set of portfolio assets.
- Oversees evaluation of adverse events for overall assessment of benefit-risk.
- Contributes to the preparation of submission documents for INDs and CTAs to regulatory agencies.
DESIRED SKILLS & QUALIFICATIONS:
- MD or MD-PhD with 6+ years industry experience, preferably within both large pharma and biotech environments.
- Demonstrated knowledge of and history of success in clinical development of novel agents, either small molecule or biologics, preferably within the Gastrointestinal Disease therapeutic area.
- Prior experience with preclinical or clinical asset evaluation as part of scientific due diligence in the therapeutic area is strongly preferred.
- Thorough knowledge of clinical research concepts, practices, and GCP & ICH guidelines.
- Experience working with internal and outsourced matrix-structured clinical development teams.
- Analytical mind-set with excellent technical and problem-solving skills.
- Proven experience in contributing to the overall strategic direction of an R&D organization.
Janene Cleary, Director Life Sciences Recruiting
Phone: 267-483-5233 x 103
The Bandish Group, LLC
Life Sciences Executive Search
1432 Easton Road, Warrington, PA 18976