Title: Sr Director, Clinical Research - Gastroenterology
FTE/Direct Hire Opportunity
Location: Foster City California 94404 (Remote during Covid)
Start Date: ASAP
Must be authorized to work in US without restriction or sponsorship
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.
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).