Senior Director, Pharmacometrics (Remote)

at  Jazz Pharmaceuticals

REQUIRED EDUCATION, KNOWLEDGE, SKILLS, AND ABILITIES

• PhD in pharmaceutical sciences, engineering, statistics, mathematics, or a drug development-related field with 12+ years of experience in the pharmaceutical or biotechnology industry
• A broad understanding of drug development as evidenced by a track record of significant contributions to successful Regulatory Agency interactions, NDAs and/or BLAs, drug approvals, in-licensing deals, and peer reviewed publications.
• Proven ability to build and lead a pharmacometrics team, ideally with outsourcing components and including organizational design and the recruitment, development and retention of talented pharmacometricians
• Proficiency in quantitative analyses (including population PK, PK/PD, exposure-response, and disease modeling) using NONMEM, R and other common pharmacometrics software
• Prior experience in applying model-informed drug development in multiple therapeutic areas
• Extensive understanding of global regulatory requirements and significant experience in regulatory authority interactions
• Experience in managing people
• 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.
• Experience working in oncology is preferred.
• 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.

This position has varying responsibilities relating to clinical pharmacology, pharmacokinetics (PK), and pharmacodynamics (PD) but are not limited to:

• Planning, preparing and reviewing pharmacometrics-related drug development plans and regulatory filings. This includes determining scope, design planning and implementation of modeling & simulations, and exposure-response analyses. Responsibilities include describing results of these studies in various regulatory documents (IND, NDA, BLA, IB, etc.)
• Apply model-informed drug development principles to guide decision making
• 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 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 direct reports, oversee their deliverables, and uphold the highest scientific standards and encourage innovation
• Directs and ensures that the pharmacometrics 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
• Ensure high quality review and approval of pharmacometrics deliverables, including regulatory documents, publications, and data presentations
• Foster and ensure a culture of transparency
• Maintain up to date knowledge of regulatory agency pharmacometrics guidelines and maintain a command of relevant scientific literature and evaluate implications for internal projects
• Develop and administer budgets, resource plans, and performance objectives for the pharmacometrics staff
• Represent pharmacometrics as a subject matter expert and thought leader
• Represent Jazz in interactions with regulatory agencies and respond to regulatory inquires related to pharmacometrics
• Participate in the evaluation of potential in-licensing candidates
• Other responsibilities and duties, as required