Sr Director, Clinical Research - Gastroenterology (MD)

Title: Sr Director, Clinical Research - Gastroenterology FTE/Direct Hire Opportunity Location: Foster City California 94404 (Remote during Covid) Start Date: ASAP No C2C/Corp-to-Corp Must be authorized to work in US without restriction or sponsorship Responsibilities:

• You will oversee scientific and medical studies involving internal assets targeting inflammatory bowel disease.
• You will provide input and direction on strategic development of internal assets from the drug discovery stage through product registrations worldwide.
• You will report to a more senior member of the inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
• Conceptualizing, planning and executing clinical trials.
• Preparation and review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
• Medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Manage the preparation and/or review of data listings, summary tables, study results, study reports, and clinical modules for filings.
• Prepare presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
• Develop manuscripts for publication in peer-reviewed journals.
• Provide scientific and clinical guidance to Biology, Toxicology, Clinical Operations, Biometrics, Global Drug Safety, Regulatory, and Project Management functional areas
• Assist in the clinical evaluation of business development opportunities. Skills:
• MD or equivalent. Gastroenterology fellowship or experience in gastroenterology preferred.
• 3+ years' experience in drug development. Experience in drug development for IBD or other inflammatory diseases preferred.
• Experience in the oversight and design of clinical research studies with understanding of Good Clinical Practice.
• Ability to understand and communicate scientific concepts related to drug pharmacology, pharmacokinetics and toxicology.
• Experience with developing relationships and collaborations with external experts in discussions related to study design, study conduct, and interpretation of clinical results.
• Strong leadership skills with an ability to set vision, lead change, and mentor others.
• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue.
• Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
• Excellent scientific written and oral communication skills.
• Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (10% travel expected).