Sr. Vice President, Clinical Development, Transplant

LifeMine•Watertown, MA

About The Position

Reporting to the Chief Medical Officer, the SVP of Clinical Development, Transplant will provide strategic and operational leadership to ongoing and new clinical development programs. The SVP of Clinical Development, Transplant will act as the primary clinical lead on assigned trials, supporting protocol development, study management, analysis and interpretation of data, completion of study reports, and documentation preparation and review. The SVP of Clinical Development, Transplant will provide clinical and medical insights and input as a member of cross-functional development teams and will partner effectively internal and external partners and stakeholders. This person will be responsible for developing relationships with sites and Key Opinion Leaders in the Transplant community.

Requirements

Experience with Transplant in either an academic and/or biotechnology/pharmaceutical setting
Biotechnology/pharmaceutical and/or academic relevant experience leading clinical drug development (early-stage development through approval), including developing clinical protocols, study design and successful regulatory approval (INDs, BLAs, NDAs) with US and international regulatory agencies
Proven clinical development experience designing, implementing and conducting clinical trials, with emphasis on translational strategies and early clinical development including proof-of-concept and first-in-human studies
A history of strong collaboration and personal interaction with all levels of internal stakeholders including, Regulatory Affairs, Clinical Operations, Research, and Product Development
Demonstrated success working with and influencing key external stakeholders (KOLs, investigators, researchers) including presenting/responding to the FDA and other regulatory authorities
Understanding of global pharmacovigilance regulatory requirements and guidance documents and proven ability to influence decision making around multifaceted issues involving medical safety
Outstanding leadership skills; comfortable working in a flexible, dynamically changing and challenging environment
Excellent strategic planning, organizational and communication skills
Highest level of scientific integrity
Expertise and consistent success in scientific research and/or clinical practice, as evidenced by appropriate higher qualifications, publication and/or relevant specialist accreditation
Strong computer skills including MS Office Suite (Word, Excel, PowerPoint, Outlook, MS Project) and in the use of industry-standard software (e.g., electronic data capture systems) and proficient in data analysis software and data presentation
Willingness to travel ~25%, with international travel at times

Responsibilities

Lead and design translational medicine and clinical development strategies for one of more clinical programs.
Lead efforts to develop strategic partnerships with Key Opinion Leaders and engage with the Transplant community
Lead activities related to phase 1-4 clinical trials (e.g., develop protocols, investigator brochures, and clinical study reports; review clinical trial documents, CRO management, clinical support of regulatory interaction, and study analysis and reporting).
Partner with Biology and Biomarkers & Precision Medicine to development translational biomarker plans that are integrated into clinical trials
Partner with Quality Assurance, Regulatory Affairs, and Project Management to ensure timely and effective clinical and scientific input into overall program.
Lead investigator meetings and site initiation visits with clinical trial investigators, and partner with Clinical Operations in driving enrollment into the clinical studies
Represent the company at scientific meetings, patient advocacy events and presentations, as well as other public relations opportunities, as directed by the CMO and Clinical Development
Study Data Review and Analysis
Provide clinical input into statistical planning and lead data analysis and interpretation
Perform ongoing review and analysis of study data
Provide medical leadership as needed for scientific issues that may arise during clinical trial execution
Provide medical leadership and support for publication of data (e.g., manuscripts, posters) and disease or technology related scientific publications
Define, plan and provide Medical Monitoring to clinical development studies
Review adverse events, monitor safety, and prepare analysis and regulatory submission.
Conduct thorough medical review of individual case safety reports (ICSRs)