Reporting to the Vice President of Clinical Development, the Senior Medical Director, is responsible for strategic planning and execution of the assigned clinical program(s) from an end-to-end clinical development perspective, covering phases from IND preparation to approval.

You will have experience in the drug development process, particularly early phase clinical trials, protocol writing and study conduct, data review and reconciliation, and what it takes to lead teams successfully. This position offers the opportunity for growth and development while working in a vibrant environment.

Responsibilities:

• Establish clinical development plans and deliver on program milestones, in partnership with clinical leadership.
• Work effectively with in a matrix environment with other functions.
• As a senior member of the clinical study physicians team, provide leadership, mentorship, and guidance to other team members.
• Serve as the Medical Monitor on one or more studies.
• Author and review clinical documents required for the conduct of clinical studies, such as clinical protocols, amendments, informed consent documents, investigator brochures.
• Author and review clinical sections of regulatory documents, including INDs, annual safety reports and briefing packages.
• Lead clinical engagement with IRBs and Ethics committees.
• Work closely with internal teams and CROs in execution of trials, and provide ongoing guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategies.
• Serve as medical point of contact with sites: answer site questions about patient eligibility, enrollment and provide clinical input into patient safety assessment and management.
• Participate in ongoing clinical data cleaning and review and contribute to clinical study report drafting and/or review.
• Lead ongoing data review, analysis, and interpretation to understand safety and efficacy profile.
• May act as a core member of the Safety Management Team (SMT), supporting overall program safety interpretation and reporting in collaboration with Pharmacovigilance team members.
• Present clinical program at Site Initiation Visits, Investigator’s Meetings, and scientific conferences.
• Prepare presentation materials for internal and external meetings, such as clinical team meetings, Scientific and Clinical Advisory Boards and Board of Director meetings.
• Identify and build collaborative relationships with key opinion leaders and institutions to assure incorporation of latest methods and guidelines into clinical development plans.
• Lead all aspects of planning and management of investigator meetings, advisory boards and other scientific committees.
• Co-author and present abstracts, posters, and oral presentations for scientific and clinical meetings.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
• Work effectively with in a matrix environment with other functions.
• Provide clinical input into discovery initiatives and for business development activities.
• Manage a team of Medical Directors.
• Some Travel required.