- Responsible for planning and executing state-of-art Clinical Pharmacology program and M&S strategy to support Cerevel portfolio including Go/No-go decision making and dose finding strategies
- Oversee the design and protocol writing of clinical pharmacology studies (e.g., food effect, human ADME, drug-drug interactions, QTc, and hepatic/renal impairment)
- Lead or Co-lead all quantitative pharmacology activities to support both regulatory filings and internal decision-making (e.g., Exposure-Response, QTc prolongation risk assessment, population PK/PD analysis) by working closely with internal colleagues (i.e. DMPK, toxicology, biology, clinical, statistics) and external vendors to advance programs from Phase I to late-stage development
- Independently formulate clinical pharmacology strategy to support regulatory submissions
- Establishing tools and methods which create opportunities for novel solutions
- Anticipates potential multi-discipline problems and proposes innovative mitigation strategies
- Manage external contract research organizations
- Draft clinical pharmacology components of protocols, INDs, investigator's brochure and other regulatory documents
- Provide ad-hoc support to other programs as needed
- Experience supporting small molecule programs
- Effective verbal and written communication skills are essential for the role
- Hands-on experience in performing population PK and PKPD modelling using NONMEM/R or similar software is preferred
- Ph.
- Phd with 3+ years of industry experience
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Senior Manager, Clinical Pharmacology - Boston, United States - Cerevel Therapeutics
Description
Company OverviewCerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases.
We are tackling neuroscience diseases with a differentiated approach that combines expertise in neurocircuitry with a focus on receptor selectivity.
Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders, including schizophrenia, epilepsy, Parkinson's disease and substance use disorder.
Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people's lives.
Cerevel aspires to develop and nurture a culture characterized by trust, respect, courage, curiosity, and compassion, with a relentless focus on mission and results.
The successful candidate will bring their own unique thinking and approach to Cerevel while sharing our core values and convictions.
Role SummaryIn this highly visible, impactful role, this person will lead clinical pharmacology and pharmacometrics activities to support Cerevel's portfolio. You will have the opportunity to present clinical pharmacology plans, updates, and results to project teams and senior management.
This role will be responsible for planning clinical pharmacology components of clinical programs and studies (protocol drafting; study oversight, and reporting).
Strong quantitative pharmacology skills are necessary and hands-on experience in the implementation of common software tools (e.g., NONMEM, R) for PK and PK/PD analyses is preferred.
Self-motivation, strong scientific reasoning and communication (both verbal and writing) skills, and the ability to function effectively in a team environment are highly desirable.
Key Responsibilities
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
