Manager, Clinical Pharmacology
Company: Bausch Health
Location: Brownsville
Posted on: January 20, 2023
Job Description:
Bausch Health is a global company that develops, manufactures
and markets a differentiated product portfolio across multiple
high-growth therapeutic areas including Gastroenterology, Generics,
Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry.
We are delivering on our commitments as we build an innovative
company dedicated to advancing global health. Each day, Bausch
Health products are used by over 150 million people around the
world.Our approximately 7,000 employees are united around our
mission of improving peoples lives with our health care
products.The Clinical Pharmacology Department is seeking an
experienced and talented individual to lead a clinical pharmacology
team that will enable and assist the early- and late-stage clinical
development of internal pipelines. As a subject matter expert, this
person will be responsible for the strategic planning and tactical
execution of clinical pharmacology, pharmacometrics, and
model-based approaches to support drug development. The ideal
candidate will represent their function on study and project teams
and will ensure the successful design and execution of development
plans that include characterization and prediction of the
pharmacokinetics, pharmacodynamics, and drug-drug interactions of
the drug candidates in clinical settings. Prior experience with
preparation and review of regulatory filing documents to support
IND, IB, FIH, CTA and NDA/BLA filings is essential. Knowledge of
ICH requirements for clinical pharmacology is essential. Experience
in dealing with global development and small molecules, peptides
proteins, recombinant molecules and biologic molecules is
preferred.PRIMARY RESPONSIBILITIES:
- Providing scientific leadership on clinical pharmacology to
support R&D and corporate strategy
- As Clin Pharm program lead, supports development project teams
across diverse therapeutic areas that containing small molecule and
protein therapeutics, contribute to the project strategies
- Supervising, developing, and mentoring junior level
scientists.
- Developing and implementing new clinical pharmacology tools and
technologies to drive smarter drug development for programs.
- Developing and maintaining collaborative working relationship
with colleagues within and outside the department.
- Design, execute, analyze, and present related data to internal
project teams and senior management.
- Developing clinical pharmacology plans, timelines, and
priorities to meet regulatory requirements across Phase 1 3
studies, Phase 4, or post marketing studies as well as
bioequivalence studies: ensuring proper design and flawless
execution of dedicated clinical pharmacology studies where
applicable
- Oversee and ensure the proper conduct of PK and PK/PD analyses,
and guide PK/PD modeling and simulation work as needed to for
various drug discovery and development programs
- Developing model-based justifications for optimal doses
selected for clinical studies including pediatric dosing
justification
- Providing effective communication with cross-functional groups,
working closely with clinical study team and due diligence
teams
- Authoring/reviewing/approving relevant sections of clinical
protocols, analysis plans, study reports and regulatory
submissions.
- Maintaining a high standard for good clinical practice,
compliance, and ethics
- Maintaining and establishing relationships and agreements with
contract vendorsQUALIFICATIONS:
- 5+ years experience in clinical pharmacology required
- Ph.D. or PharmD in Pharmaceuticals Sciences, Pharmacokinetics,
Drug Metabolism, or a related field required
- Experience in population modeling and simulations; manage
analysis, including population PK modeling, PK-PD modeling, and
simulation to support dose selection, exposure-response, and
exposure-safety analyses
- Has written and authored IND, NDA/BLA, global regulatory filing
sections related to clinical pharmacology and pharmacology
- Has experience with interaction with FDA and other regulatory
agencies
- Understanding and ability to apply appropriate regulatory and
ICH guidelines in the design, analysis, and interpretation of
clinical pharmacology studies
- Strong written, verbal, and interpersonal communications skills
including ability to communicate scientific information clearly and
effectively
- Demonstrated ability to work effectively with cross-functional
groups in a matrix team environment.
- Has experience evaluating and selecting vendors for clinical
pharmacology studies
- Has expertise in using modelling and simulation software
(GastroPlus. WinNonlin etc)
- Has experience in managing a group of scientistsAs required by
law, Bausch Health provides a reasonable range of compensation for
roles that may be hired in the US. Actual compensation is
influenced by a wide array of factors including but not limited to
skill set, level of experience, and specific office location. For
this role, the range of starting pay for this role is 170k
180K.Benefits package includes a Comprehensive Medical (includes
Prescription Drug), Dental, Vision, Health Savings Account with
company contribution, Flexible Spending Accounts, 401(k) matching,
3-weeks paid time off plus 6 days paid sick time (unless a state or
city-specific policy applies) to start (pro-rated for new hires),
Employee Stock Purchase Plan, tuition reimbursement, parental
leave, short-term disability, long-term disability, life insurance,
accidental death & dismemberment insurance, 12 paid holidays
(including floating holidays), Employee Assistance Plan, commuter
benefit, recognition awards, voluntary benefits (including Identity
Theft, Student Loan and Breast Milk Shipping), employee referral
bonuses and employee discounts.This position may be available in
the following location(s): [[location_obj]]All qualified applicants
will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, national
origin, disability, or veteran status.Job Applicants should be
aware of job offer scams perpetrated through the use of the
Internet and social media platforms.To learn more please readBausch
Health's Job Offer Fraud Statement
(https://valeant.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=224770&hashed=-1624416981)
.Bausch Health is an EEO/AA employer M/F/D/V.
Keywords: Bausch Health, Brownsville , Manager, Clinical Pharmacology, Healthcare , Brownsville, Texas
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