Executive Director, Clinical Development Program Lead (Neuropsychiatry)
Scorpion Therapeutics, Madison, New Jersey, us, 07940
Role Summary
Executive Director, Clinical Development Program Lead (Neuropsychiatry) leads the clinical development strategy for assets or indications in Neuropsychiatry. The role sits within Clinical Development, a global function dedicated to the effective design and execution of drug development, including strategy, design, execution and interpretation of clinical trials. The role directly supervises multiple Clinical Development Leads who supervise individual Clinical Trial Physicians, supports disease/indication strategy across the franchise, and guides transitions from Phase I expansion through registrational execution. It reports to the Head of Clinical Development and is a core member of the Therapeutic Area clinical development executive leadership team. Responsibilities
Strategy and Execution: Create and communicate a vision for designing, conducting and executing innovative clinical development plans; supervise the development, monitoring, analysis and interpretation of clinical trials and oversee the clinical components of regulatory filings; contribute to disease/indication strategy with a franchise-wide view; provide strategic insights; lead due diligence for business development and advise the strategic transactions group; chair governance forums as required; build a franchise reputation to attract innovators to BMS. Drug Development Experience: Develop a Clinical Development strategy to extend programs beyond commercialization and into lifecycle management. Leadership and Matrix Management: Lead and develop a group of Clinical Development professionals (up to 50 direct and indirect reports) focused on a disease area; recruit, develop and retain talent; mentor; establish an ethical, diverse, collaborative culture; oversee budget and headcount. Stakeholder Engagement and Communication: Collaborate with colleagues across Research, Development, Regulatory, Medical, Commercial and other functions; cultivate external relationships with thought leaders, physicians and patient advocacy groups; ensure seamless transition from early development to late-stage trials (Phase II-III). Governance Participation and Signature Authority: Participate in governance ad hoc as designated; serve as PRC Chair as needed; manage signature authority for CSRs, Health Authority Briefings, DMC Charters, unblinding requests, and other clinical documents as delegated. Skills
Proven track record in managing complex clinical programs leading to regulatory submissions Deep understanding of biology, targets and translational science Extensive experience working with health authorities at all levels Proven ability to manage across the full spectrum of development including registrational and non-registrational trials Proven ability to execute the BMS R&D People Strategy and lead a matrix team Able to collaborate with Commercial, Medical and all research functions from Research through Regulatory Comfortable working with cross-functional drug and product development teams in a matrix environment Skilled at external interactions and speaking engagements Skilled at attracting, developing and retaining talent Education
MD (PhD or other high level degree optional) Qualifications
The ideal candidate will be a clinical development leader with more than 10 years of extensive clinical trial, drug development, and regulatory experience, and a strong scientific background Management experience supervising MDs, PhDs or PharmDs with clinical research experience Understanding of early-stage drug development; extensive experience designing and conducting Phase I–III trials and successful regulatory filings Global experience in oncology development across multiple geographies is a plus Experience interacting with business development and licensing to evaluate in-licensing opportunities that shape oncology clinical development strategy Additional Requirements
Domestic and international travel may be required
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Executive Director, Clinical Development Program Lead (Neuropsychiatry) leads the clinical development strategy for assets or indications in Neuropsychiatry. The role sits within Clinical Development, a global function dedicated to the effective design and execution of drug development, including strategy, design, execution and interpretation of clinical trials. The role directly supervises multiple Clinical Development Leads who supervise individual Clinical Trial Physicians, supports disease/indication strategy across the franchise, and guides transitions from Phase I expansion through registrational execution. It reports to the Head of Clinical Development and is a core member of the Therapeutic Area clinical development executive leadership team. Responsibilities
Strategy and Execution: Create and communicate a vision for designing, conducting and executing innovative clinical development plans; supervise the development, monitoring, analysis and interpretation of clinical trials and oversee the clinical components of regulatory filings; contribute to disease/indication strategy with a franchise-wide view; provide strategic insights; lead due diligence for business development and advise the strategic transactions group; chair governance forums as required; build a franchise reputation to attract innovators to BMS. Drug Development Experience: Develop a Clinical Development strategy to extend programs beyond commercialization and into lifecycle management. Leadership and Matrix Management: Lead and develop a group of Clinical Development professionals (up to 50 direct and indirect reports) focused on a disease area; recruit, develop and retain talent; mentor; establish an ethical, diverse, collaborative culture; oversee budget and headcount. Stakeholder Engagement and Communication: Collaborate with colleagues across Research, Development, Regulatory, Medical, Commercial and other functions; cultivate external relationships with thought leaders, physicians and patient advocacy groups; ensure seamless transition from early development to late-stage trials (Phase II-III). Governance Participation and Signature Authority: Participate in governance ad hoc as designated; serve as PRC Chair as needed; manage signature authority for CSRs, Health Authority Briefings, DMC Charters, unblinding requests, and other clinical documents as delegated. Skills
Proven track record in managing complex clinical programs leading to regulatory submissions Deep understanding of biology, targets and translational science Extensive experience working with health authorities at all levels Proven ability to manage across the full spectrum of development including registrational and non-registrational trials Proven ability to execute the BMS R&D People Strategy and lead a matrix team Able to collaborate with Commercial, Medical and all research functions from Research through Regulatory Comfortable working with cross-functional drug and product development teams in a matrix environment Skilled at external interactions and speaking engagements Skilled at attracting, developing and retaining talent Education
MD (PhD or other high level degree optional) Qualifications
The ideal candidate will be a clinical development leader with more than 10 years of extensive clinical trial, drug development, and regulatory experience, and a strong scientific background Management experience supervising MDs, PhDs or PharmDs with clinical research experience Understanding of early-stage drug development; extensive experience designing and conducting Phase I–III trials and successful regulatory filings Global experience in oncology development across multiple geographies is a plus Experience interacting with business development and licensing to evaluate in-licensing opportunities that shape oncology clinical development strategy Additional Requirements
Domestic and international travel may be required
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