Vice President of Clinical Development

Verastem•Boston, MA

66d

About The Position

We are looking for a VP Clinical Development to drive Clinical strategy for a key Verastem Oncology program, and build a team to support multiple clinical trials! Reporting to the Chief Medical Officer, the position provides medical, and scientific, expertise and direction to expedite clinical development and works closely with the Clinical Operations Team to support and execute clinical trial conduct. This individual may also serve as the lead MD or Clinical Research Scientist on one or more specific studies or programs within our portfolio and may serve as Clinical Lead on cross-functional program level teams.

Requirements

Medical Degree required, MD/PhD a plus, Oncology Board Certified preferred
10+ years of experience in Oncology is required with clinical trials, including at least 2 trials as Medical Monitor
Relevant therapeutic area experience in PDAC, lung or CRC strongly preferred
Demonstrated experience to build develop and motivate a team of clinical development professionals
Demonstrated experience in clinical trial safety monitoring, Adverse Event reporting, and data review, and related regulatory interactions/response
Knowledge of current Good Clinical Practices (cGCP); comprehensive knowledge of clinical trial design; understanding of the overall global drug development process
Knowledge of current external regulatory environment, e.g. FDA, EMA requirements, related to clinical development
Ability to work independently and the exercise of good medical, clinical judgment in resolving critical problems not always covered by existing standards, policies and procedures
Strong interpersonal, verbal communication and influencing skills
Demonstrated ability to develop and cultivate relationships with key internal, and external, partners and stakeholders
Outstanding written communication skills, and strong analytical and presentation skills: effective at summarizing and presenting the key considerations and decision-points
Comfortable working in fast paced entrepreneurial environment, with a flexible mindset to be successful in a biotech corporate culture
Proven ability to work independently and in a team setting
Ability to travel up to 20%

Responsibilities

Responsible for the strategy and execution of a clinical development plan for an exciting Oncology program. Will lead a small team of clinical development professionals across several therapeutic indications to develop and conduct registration- directed clinical trials
Initially will serve as primary medical / safety contact for assigned clinical trials, ensuring protocol adherence by internal and external investigators and study teams
Serve as the primary contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, ensuring consistent protocol interpretation and clarification
Oversee and monitor clinical trials to ensure participant safety, data accuracy, and protocol compliance, addressing medical issues as they arise
Responsible for study-related review, assessment, escalation, documentation, and reporting of identified adverse events (AEs), serious adverse events (SAEs), and other safety-related events
Supports the clinical development of assigned programs and participates and supports the design and implementation. Provides strategic clinical science support for assigned studies and programs
Lead conference calls with investigators to discuss inclusion/exclusion criteria and provide support for site selection and patient recruitment
Support the design and execution of assigned clinical trial and/or program and works closely with clinical operations study lead and additional cross functional study team members within the assigned project to execute activities associated with the conduct of the clinical trials. May be assigned to one or one or more trials or programs based on experience
Supports the clinical/medical monitoring and associated documentation; attends and represents the clinical sciences organization on various sub-teams or other appropriate forums, act as primary point-of-contact for clinical study or program for clinical science related activities, conduct ongoing medical/safety data reviews in concert with Clinical Sciences team, and providing clinical science inputs into study reporting
In partnership with Clinical Operations study lead, may co-lead or lead study team meetings Interact on a regular basis with key internal and external partners and stakeholders, including; cooperative groups, key opinion leaders (KOLs), clinical investigators, clinicians, scientists as well as multidisciplinary internal groups
Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required
In collaboration with Data Management/Programming develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with assigned protocols
Develops and/or provides input for clinical presentation slides and other materials for internal/external meeting
Provide clinical input to internal documents and presentations for assigned studies; including clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission); as well as external publications (abstracts, posters, manuscripts)
Stays current and maintains a high level of scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment