Senior Director, Clinical Development (Vaccines) - REMOTE

Our pharmaceutical vaccine client in Boston, MA is growing and looking to add a Sr. Director, Clinical Development (Vaccines) to their team!

This role will lead the development and support the clinical development strategy taking into consideration medical, safety and scientific, regulatory and commercial aspects.

Primary Responsibilities:

The Sr. Director will be responsible for all medical and safety aspects of asset(s), Medical and safety monitoring; development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan and apply clinical/medical decision making to clinical development issues.

• Provides scientific expertise on the clinical development for assigned vaccines and takes accountability to the creation of regulatory documents such as investigational new drug applications (INDs), regulatory briefing documents, investigator’s brochures, 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, IND annual reports, EMA/ CHMP documents (other authorities and related documents as applicable), and scientific white papers. Leads/supports clinical part of interactions with the FDA, EMA and other regulatory agencies, particularly in the area of clinical development and clinical research; contributes to presentations of clinical data and assures accuracy of data in regulatory documents.
• Establishes and drives development team strategy and deliverables producing the development strategy, clinical development plan and clinical protocols. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
• Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
• Drives clinical development activities relating to the preparation / approval of synopses, protocols, other relevant documents (e.g. investigator’s brochure) and the conduct of clinical studies.
• Serves as an advisor to other clinical development team members involved in these activities and is accountable for the successful design and interpretation of clinical studies.
• Presents study conclusions to Management and determines how individual study results impact the overall vaccine strategy.
• Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual subjects.
• Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.
• Assesses overall safety information for studies and vaccines in conjunction with pharmacovigilance.
• Oversees non-medical clinical programs and trial team members with respect to assessment of these issues.
• Makes decisions regarding study conduct related to scientific integrity.
• As assigned, directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned vaccines, and the preparation of relevant documents and/or direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.
• Lead roles will also be taken on the incorporation of advice/recommendations received into the design of clinical studies/programs as appropriate, accountable to senior leadership for the successful completion of related objectives.

Requirements:

• Medically-qualified candidates: MD or internationally recognized equivalent plus 12-15 years’ of relevant experience, preferably within the vaccines industry.
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
• NDA/MAA/regulatory submission experience preferred.
• Management experience.
• 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.
• Diplomacy and positive influencing abilities across multinational business cultures.
• Therapeutic area knowledge relevant to mechanisms of action of vaccines in remit.
• Regional/global regulatory requirements.
• GCP/ICH.
• Emerging research in designated therapeutic areas.

Licenses / Certifications:

• Maintain minimum standards of education/certification in individual professional discipline.

Travel Requirements:

• National / international travel based on business needs.