The Vice President, Nonclinical Development and Clinical Pharmacology will provide hands-on leadership for development and execution of Jazz Pharmaceuticals R&D-wide strategy for nonclinical development (nonclinical pharmacology, toxicology, nonclinical ADME, etc.) and clinical pharmacology. Responsibilities span all development stages, including marketed products (e.g., post marketing toxicology commitments, clinical pharmacokinetics for line extensions), development projects, as well as exploratory studies to support evaluation of potential pipeline expansions.
- Accountable for the design, execution, analysis and interpretation of nonclinical development and clinical pharmacology studies and data, to enable creative and timely regulatory submissions globally that satisfy regulatory expectations and requirements.
- Ensure the integration of nonclinical and early clinical findings with planned clinical programs; secure cross functional alignment and transparent discussion of opportunities and risks, with clear plans to further investigate, optimize, and track throughout development.
- Provide support to Tech Ops (Manufacturing/CMC) to problem solve real-time issues associated with commercialized products.
- Partner with the Global Molecule Teams and support their efforts to explore the validity and strength of potential pipeline expansions.
- Foster and maintain strong collaborative working relationships within R&D and with R&D partners (e.g., Franchise Teams, Global Molecule Teams, Corporate Development, Technical Operations) to shape strategy, develop creative yet viable scenarios, guide execution of deliverables, and proactively identify and address issues, and work in close partnership with multidisciplinary teams including, but not limited to, nonclinical, clinical and regulatory functions to advance preclinical and clinical projects and influence R&D decisions.
- Provide guidance on potential business development opportunities. Participate in ad hoc due diligence activities, and provide expertise from a nonclinical development and clinical pharmacology perspective to Corporate Development.
- Effectively and transparently manage multiple, at times conflicting priorities, and proactively seek creative yet viable solutions to resolve such conflicts.
- Appropriately balance the internal infrastructure and capabilities vs. outsourcing, while ensuring systems are in place to safeguard a GxP compliant environment.
- Hire, develop and retain key scientific and managerial talents and ensure adequate program, discipline and role-specific training is provided, and drive a high-performance, nimble operating culture throughout the function which emphasizes Jazz values. Mentor and supervise team members, uphold the highest scientific standards and encourage innovation.
- Directs and ensures that the activities of the department are in compliance with record management, resource management, vendor management best practices and fosters a culture of continued process improvement.
- Maintain an effective network of outside partners, collaborators and service organizations, and work with high-quality CROs that meet the highest standards scientifically and ethically.
- Contribute to the overall leadership of Jazz Pharmaceuticals, including being a proactive and accountable member R&D governance committees and the executive R&D leadership team.
- Ensure high quality review of key study documents, including protocols, study reports, regulatory documents, publications, and formal and informal presentations of study data.
- Foster and ensure a culture of transparency of progress against department infrastructural goals and various team goals, by modeling best practice for risk and issue identification, communication, and mitigation/management at the R&D Leadership Team.
- Maintain up to date knowledge of regulatory agency nonclinical/clinical pharmacology and toxicology regulations/guidelines, and maintain a command of relevant scientific literature and evaluate implications for internal projects.
- Represent nonclinical development and clinical pharmacology as a subject matter expert and thought leader. Develop and maintain relationships with KOLs, clinical researchers, and academicians.
- Develop and administer budgets, resource plans, and performance objectives for a functional area staff of ~ 15 employees.
- Other responsibilities and duties, as required.
- PhD (or MD) in a drug development-related disciple with 15+ years of experience in the pharmaceutical or biotechnology industry, with 10+ years of direct experience in nonclinical development. Clinical pharmacology expertise a plus.
- A broad understanding of drug development as evidenced by a track record of significant contributions to successful patents, INDs, Regulatory Agency interactions, NDAs, drug approvals, in-licensing deals, and peer reviewed publications. Global experience is strongly desired.
- Proven ability to build and lead an excellent nonclinical development / clinical pharmacology function, ideally with extensive outsourcing components and including organizational design and the recruitment, development and retention of first-rate personnel.
- Proven creativity in balancing project needs and department resources (Demand vs. Supply) in a unique, fit-for purpose model.
- Experience building and managing collaborations with scientists, contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations.
- Proven track record of being a strategic thinker and a tactical implementer. Ability to think critically and solve problems, possesses a quick and analytical mind, is a fast-learner and works well in an organization that places a high value on intellectual capacity.
- Excellent written and oral communication skills.
- Comfortable in an entrepreneurial organization, wherein all leaders must take a hands-on approach and the environment is fast-paced and challenging.
- Must embody and model Jazz Pharmaceuticals core values.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.