Senior Director, Clinical Development
Location: Northern, CA or Seattle, WA
Contact: info@bandishgroup.com
THE ROLE:
Senior Director, Clinical Development Liver | Research-based biopharmaceutical company
DESCRIPTION:
We have been engaged to identify a highly qualified individual to serve as a Clinical Development Lead and Physician responsible for clinical trial programs in the Inflammation and Fibrosis therapeutic area.
Clinical development activities include molecules/products targeting primary biliary cholangitis (PBC), other cholangiopathies, and metabolic dysfunction-associated steatohepatitis (MASH).
The ideal candidate would have a strong clinical background in hepatology, along with experience in drug development. As Clinical Development Lead, you will be accountable for the design, conduct, evaluation, close-out, and reporting of clinical trials for the assigned molecules /products. One may take the lead on the development, implementation, and execution of the clinical development strategy for the assigned molecules/products, which will include constructing Clinical Development Plans and contributing to Target Product Profile development.
ADDITIONAL INFORMATION ABOUT THIS COMPANY AND ROLE:
One should have expert-level knowledge of drug development, as evidenced by a proven track record in setting short- and long-range drug development strategies and plans.
Have a thorough understanding of pharmaceutical regulatory requirements and their impact on the development and execution of clinical trials.
Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives, and steering committees. Able to distill complex matters into a clear business case and roadmap for execution.
Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
HIGHLIGHTS OF RESPONSIBILITIES:
Integrates with a team providing matrix leadership that ensures execution of innovative, highly proficient, and feasible strategies for drug development specific to a portfolio of therapeutics targeting inflammatory & fibrotic diseases.
Seeks to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem-solving.
Will serve as a scientific and clinical resource with the liver fibrosis organization.
Works closely with cross-functional leaders and teams to develop, implement, and oversee the clinical development strategy for the assigned molecules/products.
Routinely represents the assigned molecules/products in cross-functional steering and /or governance committees.
May lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.
May lead the Global Development Team for assigned molecules; providing scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
May act as a core team member on the Program Strategy Team, which is responsible for the full lifecycle management of the assigned products.
Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules/products.
Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
Will be part of a team responsible for the preparation/review of regulatory documents including but not limited to IND annual reports, IND safety reports, investigator brochures, and development plans, as well as managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
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 hepatology and/or gastroenterology is preferred, including a strong familiarity with chronic liver diseases including various cholangiopathies.
Experience in the biopharma industry is strongly preferred.
Multiple years’ experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting, or academia.
Extensive experience taking the lead on study concept and protocol design, regulatory filings, clinical publications, and presentations.
Multiple years’ of line management (direct reports) experience is preferred.
Experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
Demonstrated excellence leading large and complex teams in life sciences, healthcare, consulting, or academia.
CONTACT:
For additional information 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