Visionary Life Science Talent Solutions

The Associate Medical/Medical Director, Clinical Development will be an essential contributor to the scientific, clinical, and operational scope of clinical development programs with an emphasis on program-specific activities. The Associate Medical/Medical Director, Clinical Development will drive the design, planning, and implementation of study protocols for assigned investigational products and will play a key role in supporting related regulatory activities. This role will work on cross-functional program development and study management teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. This individual may also help support internal process improvement initiatives within the clinical department

Job Duties and Responsibilities
Responsibilities may include, but are not limited to:
• Partner with cross-functional program- and study-level teams with minimal oversight by senior clinicians to oversee the design and conduct of clinical studies, including operational feasibility, data management deliverables, preparation of meeting materials, communication plans, safety and medical monitoring, preparation of status update reports, and study close-out activities.
• Perform medical and related safety/efficacy data reviews with minimal oversight by senior clinicians. May be responsible for analytical support of clinical trial data, including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations.
Analyze information to assess issues relating to protocol conduct and/or individual subject safety. Prepare and communicate a clear overview of trial results.
• Provide organizational support for Data Monitoring Committees and other applicable data review committees including operationalizing the charter, preparing updates and data reviews, execution of meetings and adjudications, and communication of synthesized data reports.
• Author protocols and contributes to authoring of clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents.
• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of program-level development strategy as well as clinical trial objectives; responds to or triages questions for appropriate escalations.
• Interact closely with Medical Affairs in support of ISTs and publication strategy and plan, acts as owner of clinical data as member of publication team. Write and/or review collaborative abstracts, posters, and content for scientific meetings, conferences and publications. Support publication strategy execution including collaboration with investigators, KOLs, and other internal/external stakeholders. Present at investigator meetings and scientific conferences.
• Interact closely with the Regulatory group and regulatory agencies, taking part in regulatory submissions, investigator brochure authorship and communication with US and international regulatory agencies
• Conduct literature reviews as needed.
• Line management of junior members of the clinical team.
Qualifications
Education/Experience:
• At least 3-5 years of experience at a pharmaceutical, CRO or biotechnology company as a medical director or related role – title will be commensurate with experience.
• MD or MD/PhD with experience in patient care at the graduate medical level and beyond.
• Experience in oncology or immunotherapy clinical trials preferred. Early drug development experience highly desirable.
• Experience with data analysis and interpretation as an understanding of safety and pharmacovigilance principles required.
• Experience with health authority interactions preferred.