Medical Director GI
Location: West Coast, Remote
Contact: info@bandishgroup.com
THE ROLE:
Medical Director GI | Established Biopharmaceutical Company
DESCRIPTION:
We have been engaged to identify a Medical Director for our biopharmaceutical client. One will typically lead multiple components of clinical trial programs in IBD/inflammation clinical development. This individual may also act as the Physician responsible on certain projects.
For the assigned projects, one is accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.
HIGHLIGHTS OF RESPONSIBILITIES:
Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
Coordinates the collection and assimilation of ongoing data for internal analysis and review.
Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
Presents scientific information at scientific conferences as well as clinical study investigator meetings.
DESIRED SKILLS AND QUALIFICATIONS:
MD or equivalent with 6+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
Board certification in Gastroenterology is preferred, including familiarity with IBD management or inflammatory disease management.
Experience in the biopharma industry is preferred.
Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
CONTACT:
To learn more about this role, contact a member of our team at 267-483-5233 or info@bandishgroup.com.
The Bandish Group, LLC
Life Sciences Executive Search
Greater Philadelphia Region
www.bandishgroup.com