This is a newly created position for a clinical research function to support a rapidly expanding Infectious Disease clinical portfolio of promising therapeutics. This position will play a key role in the implementation, and execution of the clinical development plan. In this role, the candidate is expected to bring an understanding of medical, regulatory and scientific foundation to work across the drug development teams in support of the program.
The Associate Medical Director/Medical Director will be involved with multiple facets of new and ongoing clinical studies/program. You will work in a matrix organization across Clinical Operations, Regulatory, and Biometrics teams to ensure clinical trial conduct and timelines for associated key deliverables.
- Primary Responsibilities:Provide medical and scientific leadership to the clinical study team.
- Collaborate closely with Regulatory, Clinical Operations, and Biometrics to ensure tight strategic integration, implementation, and execution of clinical trials/program.
- Provide medical leadership to cross-functional workstreams.
- Responsible for the preparation, analysis, interpretation, and presentation of safety data.
- Be accountable to relevant timelines and deliverables associated to clinical research and operations plans at the clinical trials/program level.
- Responsible for medical monitoring activities, including evaluating issues related to study conduct, and individual subject safety.
- Interact frequently with investigators, site staff, CROs, and site monitors to optimize study engagement, maintain enthusiasm, and support further enrollment for ongoing and future clinical studies.
- Responsibility for major written deliverables (e.g., regulatory submissions, responses to questions from IRB/EC, congress abstracts, original articles) and presentation materials.
- Responsible for initial review with respect to controlled study/program documents including study synopses, study protocols/amendments, IB, informed consent forms, and clinical study reports.
- Maintain and analyze literature and competitive information for trial designs and results for assigned therapeutic area.
- Comply and adhere to ICH, GCP, and relevant regulatory guidelines.
- Qualifications and Requirements:A highly driven, dynamic, engaged, and accomplished physician or physician-scientist with experience and insight will thrive in this role. Specific qualifications include:
- MD or DO.
- Completion of a , clinical research experience, or focused training in Infectious Diseases or Gastroenterology a plus, but not required.
- 3+ years of industry experience or equivalent clinical academic experience a plus.
- Early-stage development and regulatory experience preferred.
- Exposure to and management of significant accelerations and challenges in clinical programs.
- Ability to work across all levels and other external audiences such KOLs and regulatory bodies.
- Excellent presentation and writing skills with a track record of publications.
- Ability to thrive in a highly entrepreneurial biotech environment, with some prior experience in a small/medium size company an advantage.
- Excellent analytical, problem-solving and strategic planning skills.
- Strong interpersonal skills commensurate with the need to work closely with KOLs, CROs, investigators, consultants, and team members across functions.
- Ability to thrive in a fast-paced environment.