Senior Director, Compound Development Team Leader, Neuropsychiatry
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Position Summary
The late development Compound Development Team Leader (CDTL) is responsible for development and execution of the compound strategy for a selected molecular entity, and operational implementation, delivered through the effective leadership of a cross-functional Compound Development Team (CDT). The CDTL is accountable for Phase 2b/3/3b/4 and post marketing clinical trials related to the compound development program and other required cross-functional activities related to lifecycle management. The CDTL leads the team to develop products in a timely and cost effective manner and is accountable for the execution of the compound strategy. Team leadership via matrix interactions includes individuals from TA strategy, GCSO, global regulatory affairs, project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, drug discovery, early clinical development, strategic marketing, CM&C, preclinical department and other scientific and business related disciplines.
Essential Functions
* Matrix Leader of Cross-functional Compound Development Team; Works with TA Leadership Team to develop compound strategy
* Leads the development and maintenance of the program plan and decision-making by providing relevant research, analysis, and expertise
* Manages successful cross-functional execution of the project plan through negotiating with Function heads about functional deliverables
* Aligns the CDT to achieve its goals through the networks of people/functions represented on the team
* Identifies critical risks and assumptions and transparently communicate them to the CDT, functions, TA & Pharma governance committees, and senior management
* Identifies issues and leads contingency planning
* Leads resolution of issues at the CDT, TA & Pharma governance committees and senior management levels
* Leads CDT problem-solving and provide decision-making tools and techniques
* Leads the communication of strategy and plans to the TA & Pharma governance committees, development partners, and other key stakeholders
* Responsible for review of medical publications emerging from the Team and its affiliates
* Accountable for the budget for the compound or program
* Works with Function heads to: Select CDT members; Set Goals and Objectives for CDT members; Mentor and guide CDT members; Provide input for performance evaluation of CDT members
* Execute the program and manage deliverables & financials
* May act, in concert with senior clinical personnel, as a company spokesperson regarding publication of clinical research findings and presentations to relevant health authorities (e.g. global health authority meeting related to NDA/MAA/BLA)
* Develop credible relationships with scientific leaders, key regulatory officials
Education And Experience
* Advanced Degree (Ph.D., M.D., M.B.A.) highly desirable
* A minimum of ten years of pharmaceutical industry or related experience overall and/or a minimum of five to seven years of drug development or related experience
* Experience in a leadership role within a multi-functional R&D organization
* Ability to integrate all cross functional disciplines into a successful strategy and project plan
* Understanding of requirements for successful commercialization of a new product
* Expert knowledge of the drug development process and the competitive environment
* Strong problem solving skills for developing creative solutions and meeting project objectives
* Demonstrated influence, negotiation and conflict resolution skills, including the ability to influence without clear reporting authority
* Significant work experience in a leadership position in a team matrix environment
* Strong planning and tracking skills
* Demonstrated ability of strategic thinking and contingency planning with respect for Johnson & Johnson Innovative Medicine objectives
* Fluent in written and spoken English
* Working knowledge of the use of Microsoft suite of software products including Excel and Word
* Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
Required Technical Knowledge And Skills
* Fluent in written and spoken English
* Working knowledge of the use of Microsoft suite of software products including Excel and Word
* Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Other
Industries
* Pharmaceutical Manufacturing
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