Senior Director, Pharmacometrics (Remote)

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: May 7, 2024

Job Description:

If you are a Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

Brief Description:

This position will provide a strategic leadership in design, oversight, analysis and reporting of pharmacometrics programs to support small and large molecule compounds in oncology from discovery through registration and post-marketing.

Essential Functions

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

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.

FOR US-BASED CANDIDATES ONLY

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.

For this role, the full and complete base pay range is $220,000-$330,000. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.

At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits

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