Senior Director, Pharmacometrics (Remote)
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: May 7, 2024
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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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Keywords: Jazz Pharmaceuticals, Santa Cruz , Senior Director, Pharmacometrics (Remote), Executive , Palo Alto, California
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