Senior Director, Global Clinical Development

Company Overview
Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson’s disease and substance use disorder.   Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives. Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results.  Our patient-centricity guides our purpose, how we treat each other and what we work on every day.  The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role Summary We are seeking a Sr. Director of Global Clinical Development, who will provide clinical development, therapeutic area, and program leadership expertise to support the strategic design, leadership, execution, and interpretation of key early and late-stage clinical development programs.  The successful candidate will demonstrate the flexibility and capability to function at a high level across multiple trials or programs. The Sr. Director will serve as the program clinical development lead for one or more assets, managing matrixed cross-functional indication program teams, and responsible for designing, implementing, and overseeing clinical development and global product level strategy, goals, and vision, accountable for key deliverables, milestones, and budget. The individual who assumes this position will interact with multiple stakeholders within Cerevel, as well as external stakeholders in the medical community and global regulatory authorities. The individual will need to be skilled and fully engaged in the development of clinical trial design, execution, data review and interpretation, including development of clinical study protocols, reports, and regulatory submissions with a cross-functional team, as well as experienced in program leadership roles and responsibilities. 

Key Responsibilities

• Serve as the clinical development lead for one or more portfolio early and late stage development programs, providing clinical leadership that integrates the individual’s knowledge in in basic science, drug development, and the therapeutic area with input from the medical community around the world, participating in all aspects of trial execution as required, including presenting at clinical study investigator meetings, trial site selection, monitoring and reviewing incoming data, engaging with study physicians, reviewing final data outputs and other activities as needed
• Serve as clinical development team lead, managing one or more matrixed cross-functional product level strategy and oversight teams, accountable for designing, implementing, and overseeing global product level development strategy, plans, goals, and vision, accountable for key deliverables, milestones, and budget
• Designs and executes state of the art clinical research strategies, integrating scientific rationale, literature and landscape research, regulatory requirements, product development plans, and commercial goals to build a solid strategic framework in support of designing and executing the Clinical Development Plan (CDP)
• In collaboration with internal/external experts on biostatistics, clinical pharmacology, clinical operations, PVCS, and data management, contributes to the development of the plan to execute on trial design including, protocol design, CRF design, study plans and manuals, data review plan, statistical analysis plan, and CRA/SIV and Investigator meeting training materials
• Supports the development of program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals
• For MD candidates: provide ongoing medical expertise and medical oversight of clinical trials, including eligibility evaluation and adverse event management, in conjunction with external and internal partners
• Responsible for the scientific training of the clinical study team, and providing medical/clinical subject matter and therapeutic area expertise to internal and external stakeholders
• Contributes to clinical trial investigator identification and selection
• Collaborates with the program team on the review, analysis, and interpretation of study results and assures approp