Medical Director
SiteOne Therapeutics
Medical
United States
Posted on Feb 5, 2025
Job Title: Director/Sr. Medical Director – R&D Clinical Science
Purpose Of This Role
Working with the Chief Medical Officer, the Director/Sr. Medical Director will contribute to the overall clinical strategy for current and future assets as well as lead clinical development activities relating to the design, execution, and interpretation of clinical trials and the associated clinical development plans.
Major Responsibilities
The Director/Sr. Medical Director will be responsible for:
- Oversees all medical aspects of study design.
- Medical monitoring of clinical studies.
- Medical evaluation of pharmacovigilance and drug safety reports (pre- and post-marketing).
- Assists with execution of clinical studies to establish the safety, efficacy and commercial viability of new products.
- Actively participates in site selection and assists with providing oversight to assure investigator compliance with the study protocols, regulatory guidelines and company standard operating procedures.
- May assist with study vendors selection and education.
- Works with Clinical and Regulatory Affairs in the preparation of project- related documents and regulatory submissions, including Investigator's Brochures, Annual Reports, INDs and NDA's.
- Is responsible for medical monitoring portion of site initiation, site oversight and monitoring, on-site presentations, site close-out and especially understanding of adverse events.
- Communicates and interacts effectively with in-house personnel, clinical sites and outside contractors/CROs.
- Has a teaching role in investigator meetings.
- Participates in the formulation of overall clinical strategy.
- Functions as medical reviewer for PV department.
- Up to 30% travel may be required.
Profile (Skills, Experiences and Qualifications Required for The Job)
- The successful candidate will be a highly motivated self-starter with strong leadership skills who thrives on working in a team environment, applies independent thought and creativity in programs or projects, and skillfully influences and holds others accountable in achieving team goals.
- An MD degree from an accredited College or University. Board Certification preferred along with a minimum of 5-10 years of relevant clinical research experience in the U.S. biotech/pharmaceutical industry.
- Proven experience in design, conduct and data analysis of registration-track global clinical trials. Experience designing and conducting rare disease clinical trials is strongly preferred. Substantial experience as an academic principal investigator for industry-sponsored trials can be considered.
- Has and maintains thorough knowledge of own therapeutic area or disease specific information, keeps abreast of relevant scientific literature and competitor development programs, and applies this knowledge to advance projects or programs.
- Acts as a therapeutic area resource and leads or assists in scientific education of investigators, study execution team and cross-functional team members.
- May represent the Company at external meetings including investigator meetings, scientific association meetings, and partner discussions,
- Knowledge of regulatory requirements governing clinical trials and extensive experience in development of and writing of registration-track clinical trial protocols plus other trial related documents.
- Experience interacting with development operations (clinical operations, regulatory, QA) and clinical investigators.
- Previous experience in providing oversight to vendor activities including CRO
- Demonstrated experience managing complex projects, and polished skills in influencing, communicating, and working collaboratively with diverse stakeholders.
- Adaptable team player able to work independently, exhibit sound judgement, and hold self and team members accountable in meeting timelines.
- Effective and engaging scientific communicator, with excellent oral and written presentation skills.
- Travel to internal meetings, external meetings, clinical sites and scientific conferences (up to 25%).