Medical Director (LN20-251)
The Medical Director will provide medical and strategic leadership for Catalyst Biosciences clinical development program, including oversight of ongoing clinical studies in inherited bleeding disorders and complement related disorders, design and execution of new clinical studies, work with cross functional partners and collaborate with external thought leaders. This position will report to the Vice President of clinical development. As one of only three physicians in the company, the medical director/senior medical director will have the opportunity to play an integral role in shaping the future clinical development path of Catalyst's clinical assets.
About Catalyst Biosciences
Catalyst is a clinical-stage biopharmaceutical company focused on developing novel medicines to address important unmet medical needs in patients with rare bleeding and complement related disorders. Catalyst currently has compounds in discovery and development phases that span the value chain from the early discovery stage to late stage clinical trials with the intent of commercialization.
- Oversee medical monitoring and interpretation of data in ongoing clinical studies
- Contribute to study start up activities, eCRF development, study plans, TLFs, SAPs
- Participate in cross-functional teams with internal and external partners, KOL's, investigators
- Develop scientifically sound clinical trial protocols that are feasible to execute
- Contribute to interactions with regulatory authorities and regulatory submissions (US and ex-US)
- Author and review clinical sections of regulatory documents for global submissions, such as protocols, Investigator Brochures, CSRs, clinical elements of an IND, BLA, and MAA
- Participate in investigator meetings, advisory boards, data safety monitoring committees, and other external collaborations
- Collaborate with study investigators in the preparation, submission, and presentation of data, either oral or posters, at scientific meetings and congresses (~10-20% travel)
**Title/Level will commensurate with education and experience.
- MD/DO or equivalent
- 3-7+ years of clinical development experience in the pharmaceutical or biotechnology industry
- Knowledgeable in current GCP guidelines in the US and Europe
- Must have previous medical monitor experience and/or protocol development experience in the pharmaceutical or biotechnology industry
- Excellent communication skills (oral and written)
- Track record of effective collaboration with thought leaders and investigators
- Strong decision-making skills
- Ability to work in a fast-paced, small-company environment and prioritize with competing responsibilities
- Excellent written and oral communication skills
- Previous NDA/BLA and or MAA experience a plus
- Experience in rare disease a plus