Our vaccine client in Boston, MA is growing and looking to add a Medical Director to their team (Hybrid/Remote). Role will lead clinical development activities relating to the design, conduct, medical and safety oversight, and interpretation of clinical studies, working as part of a multi-disciplinary, multi-regional matrix team, and in collaboration with external partners including contract research organizations (CROs), principal investigators (PIs), clinical site personnel, and key opinion leaders (KOLs). Responsibilities include but not limited to:
Clinical Development Strategy
- Contributes to clinical strategy, shaping clinical development plans and the design of clinical trials critical to the licensure of the candidate vaccine.
- Proactively identifies clinical development challenges and prepares contingency plans to address them.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Leads the development/approval of clinical synopses, clinical protocols, informed consent forms and other clinical study documents in collaboration with internal team functions including biostatistics and medical writing.
- Oversees and facilitates clinical study implementation, including providing protocol-specific training for the internal study team, CROs, investigators and clinical site staff; and medical/clinical input for development of study plans and for risk assessment and mitigation planning to ensure clinical quality and protocol compliance, and to protect the safety and well-being of study subjects.
- Interprets clinical study data from an overall scientific standpoint, as well as within the context of the medical significance to individual patients. Responsible for delivery of a quality clinical study report in collaboration with the study statistician and medical writer.
Medical and Safety Monitoring
- Oversees medical monitoring activities, assessing issues related to individual and cumulative subject safety and to study conduct, and reporting to and interacting with independent Data Monitoring Committees.
- Assesses overall safety information for studies and vaccines in conjunction with Pharmacovigilance.
- Supports regulatory authority interactions by helping to author regulatory documents such as investigational new drug applications (INDs), regulatory briefing documents, investigational medicinal product dossiers (IMPD), common technical documents (CTD) as the basis for new drug applications (NDA) in the US and market authorization applications (MAA) in the EU.
- Contributes to presentations of clinical development plans and of clinical data to FDA, EMA and other regulatory agencies.
- Reviews literature and liaises with KOLs as needed to respond to clinical, scientific and programmatic questions.
- Co-authors abstracts, posters, presentations and publications.
- MD degree or internationally recognized equivalent plus 3-5 years of relevant experience in vaccine clinical development.
- Previous experience of successful contribution to clinical development activities, for example as part of clinical development team with responsibility for studies in multiple regions.
- NDA/MAA/regulatory submission experience preferred.
- Experience with and demonstrated ability to lead highly trained medical, scientific and technical professionals preferred.
- Superior communication, strategic, interpersonal and negotiating skills.
- Ability to proactively predict issues and solve problems.
- Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams.
- Therapeutic area knowledge relevant to mechanisms of action of vaccines in remit.
- Knowledge of regional/global regulatory requirements.
Licenses / Certifications:
- Must maintain minimum standards of education/certification in individual professional discipline.
- National / international travel based on business needs.