Backed by Atlas Venture.
About the role
The Senior Director, Clinical Development will lead the clinical strategy and study execution of our I&I development programs. Working closely with internal and external stakeholders, this individual will drive clinical development plans, provide medical leadership across clinical studies, and contribute to study design, protocol development, safety reviews, data interpretation, regulatory submissions, publications, and presentations.
What they're looking for
- M.D. required, significant I&I or rare disease clinical development experience strongly preferred
- Minimum of 8+ years of relevant experience with a demonstrated track record of success in clinical research and drug development within academia, biotechnology, and/or the pharmaceutical industry
- Demonstrated experience designing and executing clinical programs across multiple phases and geographic regions
- Experience with phase 1/2 clinical studies is required
- Strong knowledge of GCP, ICH guidelines, global regulatory requirements, and the drug development process
- Experience building and leading a team of direct reports and contractors
More about this role
COMPANY INTRODUCTION
Triveni Bio is breaking new ground in the identification of novel disease targets – working at the convergence of human genetics, best-in-class antibody design, and precision medicine. We are pioneering a Mendelian genetics-informed precision medicine approach to develop functional antibodies for the treatment of immunological and inflammatory (I&I) disorders. Our lead antibody program (TRIV-509) targets kallikreins 5 and 7 (KLK5/7) to directly impact skin barrier function, inflammation, and itch – providing a meaningful and much needed potential treatment option for patients with atopic dermatitis and other barrier disorders. In all the work we do, we adhere to our core values: patient impact, bold and rigorous science, open collaboration, kindness & respect.
The Senior Director, Clinical Development will lead the clinical strategy and study execution of our I&I development programs. Working closely with internal and external stakeholders, this individual will drive clinical development plans, provide medical leadership across clinical studies, and contribute to study design, protocol development, safety reviews, data interpretation, regulatory submissions,...
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