VP, Clinical

3 weeks ago

Boston, United States Vigil Neuroscience, Inc. Full time

Vigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to rapidly deliver precision-based therapies to improve the lives of patients and their families. Reporting directly to the CMO, the VP, Clinical and Medical Sciences will oversee the clinical sciences of all Vigil’s clinical stage programs with particular focus on rare disease and Alzheimer’s disease. This is a critical role within the company, having a significant impact in defining the clinical development strategy at a high level. The outstanding individual sought will need to be of the highest caliber medically and scientifically, with exceptional leadership capacity and interpersonal skills and the ability to work in a dynamic company that is growing rapidly. This means agility, flexibility, taking initiative, thinking “on the fly” and “being budget mindful”; a desire to be very hands-on, decisive, and self-assured are critical. More specifically, the VP will be responsible for providing clinical/medical leadership and support for Vigil’s Alzheimer’s disease and rare CNS indications programs as well as working closely with the CMO to further develop the early pipeline. There are several regulatory interactions globally on the horizon; this individual will provide leadership and guidance throughout the process. Close collaboration with the external environment and with Vigil’s clinical development operations, discovery, preclinical functions, and executive management will be critical. The clinical development department is highly team oriented. Trust and respect are paramount, voicing opinions and thinking outside the box in a professional and appropriate scientific/medical/clinical manner is encouraged. Decisions are made as a team and the group’s culture is one that understands there is no “only” way to do things. Hard work, critical thinking, and exceptional people skills are highly valued and expected. Key Responsibilities: Provide robust, innovative Clinical and Medical leadership for Vigil Neurosciences Clinical Development function (phases 1 through 3b). Lead the design and contribute to the execution of the clinical development programs and provide direct oversight and management of clinical and medical aspects of clinical trials. Provide medical monitoring support of ongoing and future clinical trials and act as the company’s safety physician. Responsible for protocol development, interpretation of results, and authoring of key clinical documents. Lead interactions and maintain strong, close, and collaborative relationships with Key Opinion Leaders, Investigators, and other clinical stakeholders in support of clinical development programs in lockstep with corporate strategy. Interface effectively with other departments, including Clinical Development Operations, Biometrics, Clinical Pharmacology in design and conduct of the clinical programs. Lead/participate in project teams and relevant cross-functional sub-teams to ensure tactical alignment and execution; and work with external contract research organizations (CROs). Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as VIGIL's SOPs. Present scientific information at scientific conferences as well as clinical study investigator meetings. Create and maintain a positive and productive work environment and exhibit exceptional leadership capabilities by creating trust and respect with other colleagues in Vigil. Support critical evaluations and recommendations of business development opportunities. Candidate Profile: The ideal candidate will demonstrate the following qualifications and competencies: Board Certified M.D., (Neurology, Psychiatry, etc.), or an MD, PhD with a minimum 10 years of experience in clinical development functions within a biotech or pharmaceutical company. Small company experience is a critical advantage. Outstanding, proven track record leading new medicines through all stages of CNS clinical development to marketing authorization and approval. Experienced in and knowledgeable about relevant FDA regulations and guidelines as well as those of the EU and other health authorities with sophisticated approaches to regulatory filings. Ability and willingness to travel 20% of the time (international and domestic). Well-developed leadership skills with the ability to influence, able to make decisions and stand by them. This individual will be highly visible at all levels of the organization and must be able to build trust and credibility walking in the door. Exceptionally sharp thinker: ability to push innovation and creative thinking. Strategic thinking, accountable and forward-looking; able to see larger business picture; agile. Flexible, work in a fast-paced environment and be open to change or the unknown. Collaborative and proactive, with a hands-on, roll-up-the-sleeves style and attitude. Outstanding people manager and developer with genuinely strong listening skills. Excellent interpersonal, presentation and communication skills. #J-18808-Ljbffr

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