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Clinical Pharmacology
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Director, Clinical Pharmacology
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Director, Clinical Pharmacology
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Takeda Pharmaceuticals Boston, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's · Privacy Notice · and · Terms of Use . · I further attest that all infor ...
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Director, Clinical Pharmacology
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BioSpace Boston, United StatesJob Details · By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all inf ...
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Associate Director Clinical Pharmacology
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Clinical Pharmacology Director, Vaccines
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Kura Oncology, Inc. Boston, United StatesAre you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. · At ...
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Third Rock Ventures Boston, United StatesAs our clinical development portfolio evolves, Tango has an exciting new opportunity to join our team as a Director/Senior Director, Clinical Pharmacology. Reporting to our SVP, Pharmaceutical Sciences, you will be responsible for the design and implementation of clinical pharmac ...
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Vertex Pharmaceuticals Boston, United StatesJob Description · General Summary: · The Director, Modeling & Simulations (M&S) Pharmacometrics will be responsible for?independently determining, planning, and executing M&S analyses for an entire drug development program in close collaboration with cross-functional colleagues w ...
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Vertex Pharmaceuticals Boston, United StatesDirector Clinical Pharmacology Modeling and Simulations page is loaded · Director Clinical Pharmacology Modeling and Simulations · Apply · locations · Boston, MA · time type · Full time · posted on · Posted 2 Days Ago · job requisition id · REQ-20569 · Job Description ...
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Global Head of Preclinical Pharmacology
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PepGen Boston, United StatesPosition Summary · PepGen is seeking a highly motivated and innovative Principal Scientist to join the Preclinical Research and Development group in Boston, Massachusetts. We are looking for a senior scientist who brings enthusiasm, curiosity, scientific rigor, and a desire to tr ...
Senior Manager, Clinical Pharmacology - Boston, United States - Cerevel Therapeutics
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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 ResponsibilitiesResponsible 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 developmentIndependently 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
Required Qualifications
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
Education
Ph.
D., or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines
Phd with 3+ years of industry experience
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.