Senior Director, Global Clinical Development

Company: Cerevel Therapeutics, Inc.
Location: Boston
Posted on: March 20, 2023

Job Description:

Senior Director, Global Clinical DevelopmentPosted: 02/15/2023Company OverviewCerevel 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, as well as the co-lead of the product development team, 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 product development team co-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 oversight of clinical trials, 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 appropriate data review and accurate data reporting
• Identifies study issues and program issues by reviewing and monitoring emerging clinical data related to safety, efficacy and PK/PD. Develops sound, strategic solutions to issues and collaborates with the clinical study team and medical monitors to facilitate issue resolution. Conducts literature reviews as needed for the interpretation of study data and development of next steps. Responsible to work with external experts to interpret trial data
• Develops credible relationships with opinion leaders, medical directors, clinical investigators, and key stakeholders
• Develops presentations and communicates clinical program strategy and study data results to colleagues internally and to external audiences as required
• Supports and/or leads the development of clinical/medical advisory panels and steering committees
• Develop and maintain relationships with other functional areas and program team members, such as Research, Pre-Clinical/Toxicology, Regulatory, Clinical Operations, Clinical Pharmacology, Biostatistics, PVCS, Pre-Clinical, CMC, Medical Affairs, HEOR, Commercial/Marketing
• Contribute to the development of strategic initiatives, specific Business Development activities, and various organizational initiatives in Clinical Development
• Supports and/or leads health authority interactions
• Critically reads and evaluates the relevant medical literature; know the status and data from competitive products; and keeps updated with medical and other scientific developments relevant to the product
• Must ensure adherence to all requirements of good study conduct and standards of Good Clinical Practice
• May have one or more direct reports and/or oversee activities of contract medical personnelRequired Qualifications
  • Minimum of 5 years of clinical development experience in designing, planning, executing, reporting, and publishing clinical studies within the pharmaceutical industry. CNS preferred, but not required
  • Experience in leading cross-functional global program teams in early or late stage development is required
  • Thorough understanding of the drug development process from pre-IND through registration and post-registration required
  • Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization)
  • Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms to apply knowledge to support a robust clinical development strategy
  • Understanding of trial design and statistics to apply knowledge to the design of clinical protocols
  • Successful track record for the ability to interpret, analyze, and present clinical data, including aggregate data analyses, to inform decision-making and set clinical strategy
  • Detailed knowledge of GCP, ICH Guidelines and current health authority regulations
  • Excellent interpersonal skills, ability to influence and drive in a cross-functional environmentEducation
    • MD, DO, or PhD required
    • The Company requires all employees to be vaccinated against COVID-19, including to have received a booster dose of a COVID-19 vaccine if eligible to receive one. In connection with your onboarding process, all new employees will need to provide documentary evidence of vaccination. The Company is an equal opportunity employer and will provide reasonable accommodations to those individuals who are unable to be vaccinated consistent with federal, state and local lawCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.Open positionsCerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.

Keywords: Cerevel Therapeutics, Inc., Boston , Senior Director, Global Clinical Development, Healthcare , Boston, Massachusetts