Executive Director, Clinical Development IBD (MD)

Proclinical is seeking an Executive Director of Clinical Development for a global biotechnology company located in San Francisco, CA. As the Clinical Development Executive Director, you will lead a portfolio of clinical trial programs in inflammation clinical development for the inflammatory bowel disease (IBD) therapeutic area. You may act as or oversee other Clinical Development Leads across the assigned project portfolio.

Job Responsibilities:

• Leads or otherwise oversees and directs the development of the Target Product Profile and Clinical Development Plan for assigned molecules / products.
• 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 Global Development Team (GDT) for assigned molecules and / or assign GDT leadership to direct reports to ensure clinical development project deliverables and timelines are consistently met.
• May act as a core team member on the Program Strategy Team or assign this role to direct reports to ensure appropriate clinical development input and direction into the full lifecycle management of assigned products.
• Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for assigned molecules / products.
• In general, serves as the lead for communications, both written and oral, with health authorities.
• Provides or oversees ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Leads or otherwise oversees and directs the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
• Oversees and directs as needed the collection and assimilation of ongoing data for internal analysis and review and 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. Where applicable, takes a lead on authoring scientific publications.
• May assist in the clinical evaluation of business development opportunities.
• Develops thought leader and other external relationships that can guide short- and long-range clinical development strategies and direction for multiple molecules, the disease or therapeutic area overall.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as SOPs.
• Typically manages a team of direct reports.

Skills and Requirements:

• MD or equivalent with 8+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment. Prior experience in IBD is strongly preferred.
• Board certification in gastroenterology is preferred.
• Regarded as a thought leader in IBD.
• Extensive experience leading high-complexity cross-functional drug development strategies and plans in life sciences, healthcare, consulting or academia, including short- and long-range strategic planning, governance and oversight.
• Multiple years' line management (direct reports) experience is preferred.
• Extensive experience interacting with and presenting to executives and managing large-scale budgets and other resources is strongly preferred.
• Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences, healthcare, consulting or academia.
• Has an expert-level of knowledge of drug development, as evidenced by proven track record in setting short- and long-range drug development strategies and plans.
• Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.
• When needed, ability to travel.

If you are having difficulty in applying or if you have any questions, please contact Cyrus Nazari at (+1) 619-754-8724 or c.nazari@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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