- Lead and oversee the development of clinical pharmacology strategies at different stages of drug development.
- Design and contribute to the development of clinical trial protocols, specifically focusing on the clinical pharmacology aspects.
- Prepare and review the clinical pharmacology sections of IND application documents, including relevant reports.
- Analyze and interpret safety, efficacy, and pharmacokinetic data from a clinical pharmacology perspective.
- Develop and utilize quantitative pharmacology tools to support PK/PD analysis and interpretation.
- Ensure compliance with NMPA/FDA/EMA regulations and guidelines in the design and execution of clinical pharmacology studies.
- Collaborate with cross-functional teams to provide clinical pharmacology expertise and support to clinical trial design.
- Provide professional responses to inquiries related to clinical pharmacology from regulatory authorities such as CDE.
- Manage and coordinate activities with external vendors, including pre-clinical teams and testing CROs.
- Master's or Ph.D. degree in Clinical Pharmacology or related field.
- Minimum of 8 years of experience in clinical pharmacology within the pharmaceutical or biotech industry.
- Strong knowledge of pharmacokinetics and pharmacodynamics, with experience in drug development processes and regulatory interactions.
- Proficient in designing and leading clinical pharmacology studies, including PK-related designs for innovative drugs.
- Familiarity with quantitative pharmacology and bioanalysis techniques.
- Excellent communication, leadership, and collaboration skills.
- Strong understanding of NMPA/FDA/EMA regulations and guidelines related to drug metabolism, pharmacokinetics, and clinical trial design.
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Clinical Pharmacology
6 days ago
The Bandish Group Boston, United StatesClinical Pharmacology Director, Vaccines · Location: Greater Washington DC Area · Contact: Jackie Bandish, · THE ROLE: · Clinical Pharmacology Director, Vaccines | Leading Global Biopharmaceutical Company · DESCRIPTION: · This Clinical Pharmacology Director search is being condu ...
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Director, Clinical Pharmacology
1 week ago
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 Takedas Privacy Notice and Terms of Use . I further attest that all information I submit ...
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Director, Clinical Pharmacology
2 weeks ago
Takeda 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'sPrivacy Noticeand Terms of Use. I further attest that all information I submit ...
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Director, Clinical Pharmacology
1 week ago
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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Clinical Pharmacology, Associate Director
1 week ago
Mason Harding Boston, United StatesClinical Pharmacology, Associate Director - AI Drug Discovery · Boston, MA - hybrid · Mason Harding is proud to be supporting a biotech trailblazer within the field of next-gen artificial intelligence (AI) platforms to accelerate drug discovery and development; significantly cutt ...
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Clinical Pharmacology, Associate Director
1 week ago
Mason Harding Boston, United StatesClinical Pharmacology, Associate Director - AI Drug Discovery · Boston, MA - hybrid · Mason Harding is proud to be supporting a biotech trailblazer within the field of next-gen artificial intelligence (AI) platforms to accelerate drug discovery and development; significantly cu ...
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Clinical Pharmacology Director, Vaccines
6 days ago
The Bandish Group Boston, United StatesClinical Pharmacology & Pharmacometrics Director · Location: Boston, MA · Contact: Janene Cleary, · THE ROLE: · Clinical Pharmacology & Pharmacometrics Director | Leading Global Biopharmaceutical Company · DESCRIPTION: · This Clinical Pharmacology & Pharmacometrics Director sear ...
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Senior Manager, Clinical Pharmacology
1 week ago
Cerevel Therapeutics Boston, United StatesCompany Overview · Cerevel 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 p ...
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Tango Therapeutics Boston, MA, United StatesCompany Overview · Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. · Using an approach that starts and ends with patients, Tango leverages the genetic p ...
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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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director/sr. director, clinical pharmacology
1 week ago
Scorpion Therapeutics Boston, MA, United StatesScorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most ad ...
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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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VP, Early Clinical Development
6 days ago
Astria Therapeutics, Inc. Boston, United StatesAstria is seeking a creative, integrative thinker who is driven to use cutting edge approaches to advance early development, particularly clinical pharmacology and translational medicine. Reporting into the CMO, this individual will provide scientific leadership to develop and ex ...
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Postdoctoral Research Fellow, Psychiatry
1 week ago
Brigham and Women's Hospital Boston, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · We are seeking a highly motivated and dedicated Postdoctoral Research Fellow to join our research lab focused on NIH-funded clinical and translational research related to substance use disorders. The successful candidate will work collaborat ...
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VP, Early Clinical Development
1 week ago
Astria Therapeutics, Inc. Boston, United StatesAstria is seeking a creative, integrative thinker who is driven to use cutting edge approaches to advance early development, particularly clinical pharmacology and translational medicine. Reporting into the CMO, this individual will provide scientific leadership to develop and ex ...
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Vice President, Toxicology
1 week ago
HireMinds Boston, United StatesOur start-up client is building their scientific leadership team and seeking an experienced Toxicologist to join them In this role, you will lead the development and execution of the toxicology profiling of the companies drug candidates, including risk assessment /mitigation, and ...
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Clinical Development, Medical Director
1 week ago
Vertex Pharmaceuticals, Inc Boston, United StatesJob Description · General Summary: · The Clinical Development Medical Director will serve as the Surgical Lead for clinical trials, working with cross-functional teams on Surgical and trial strategy, design, execution, and reporting. In addition to oversight and accountability fo ...
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Partners Healthcare System Boston, MA, United StatesGENERAL SUMMARY/ OVERVIEW STATEMENT: · The substance use disorder (SUD) Bridge Clinic provides rapid assessment, treatment initiation, and stabilization for patients with substance use disorder, with a specific focus on equitable care which seeks to eliminate any disparities in a ...
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Physician - Hospitalist
4 days ago
Bluefox Healthcare LLC Boston, United StatesMedical Doctor - Hospitalist · Our company is looking for a Hospitalist to join our team to work with our esteemed clients. · Responsibilities: · • Develop treatment plans based on scientific rationale, standards of care, and professional practice guidelines. · • Collaborates ...
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Principal Scientist, Clinical Biomarkers
1 day ago
Meet Boston, United StatesOur client is a clinical stage biotechnology company dedicated to developing groundbreaking therapeutics that target neuromuscular disease and other hard to treat conditions. Their mission is to make a profound impact on patients' lives by pioneering first-in-class biologics and ...
Director of Clinical Pharmacology - Boston, United States - Invenia Group
Description
Invenia Group is partnered with an exciting AI powered clinical stage biotech company, headquartered in the US, who are seeking an (Associate) Director of Clinical Pharmacology to oversee and lead the clinical pharmacology team. This position requires a strong scientific background, exceptional leadership skills, and a thorough understanding of the drug development process.
Essential Job Functions:
Qualifications:
