Associate Director of Clinical Pharmacology
2 days ago
Key Responsibilities :
- Lead and contribute to the clinical pharmacology strategy, ensuring alignment with overall development plans and therapeutic goals.
- Design and oversee clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), dose optimization, and biomarker strategies.
- Interpret and analyze clinical pharmacology data, providing actionable insights to inform clinical development, regulatory submissions, and dosing strategies.
- Collaborate with internal teams, including clinical, regulatory, non-clinical, and project management, to drive the development and execution of clinical trials.
- Serve as the clinical pharmacology representative in cross-functional teams and meetings with regulatory agencies, ensuring that clinical pharmacology data supports clinical trial design and regulatory submissions.
- Lead the preparation and review of clinical pharmacology sections of regulatory documents, such as Investigational New Drug (IND) applications, Clinical Study Reports (CSRs), and New Drug Applications (NDAs).
- Stay current with emerging trends in clinical pharmacology, including new methodologies, technologies, and industry best practices.
Qualifications :
- PhD, PharmD, or equivalent degree in pharmacology, pharmaceutical sciences, or a related field.
- Minimum of 7-10 years of experience in clinical pharmacology or a related area within the pharmaceutical or biotechnology industry.
- Strong understanding of pharmacokinetics, pharmacodynamics, and the application of these principles in clinical drug development.
- Proven experience in designing, analyzing, and interpreting clinical pharmacology studies.
- Expertise in regulatory requirements and experience with regulatory submissions (e.g., INDs, NDAs).
- Ability to work effectively in a team-oriented environment and across multiple therapeutic areas.
- Strong communication and interpersonal skills with a demonstrated ability to collaborate with cross-functional teams and external partners.
-
Director, Clinical Pharmacology
2 days ago
Paramus, NJ, United States SK Life Science Full timeDirector, Clinical Pharmacology Job Locations: US-NJ-Paramus ID: 2024-1840 Category: Clinical Operations Type: Regular Full-Time Overview The Clinical Pharmacology, Director role will effectively provide support for the design, execution, interpretation, and reporting of clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This individual will...
-
Director of Clinical Pharmacology
2 days ago
, GA, United States EPM Scientific - Phaidon International Full timeWe have a current opportunity for a Director of Clinical Pharmacology on a permanent basis. The position is fully remote. Key Responsibilities: Lead the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction (DDI) studies. Develop clinical...
-
Director, Clinical Pharmacology Lead
3 days ago
Boston, MA, United States Organon & Co. Full timeOrganon & Co. Director, Clinical Pharmacology Lead Boston, Massachusetts Apply Now This position can be 100% remote in the US The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical development & translational medicine development strategy supporting development assets...
-
Director Clinical Pharmacology
3 days ago
King of Prussia, Montgomery County, United States CSL Behring Full timeCSL Behring Director Clinical Pharmacology King of Prussia, Pennsylvania Apply Now CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in...
-
Director, Clinical Pharmacology
3 days ago
Foster City, CA, United States Dren Bio, Inc. Full timeDren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune and other serious diseases. The Company's management team and scientific advisors have profound expertise covering the discovery and development of engineered antibodies designed to...
-
Principal Scientist
4 weeks ago
Cambridge, MA, United States Delphia Therapeutics Full timePrincipal Scientist / Associate Director, In vivo PharmacologyAbout Us:Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation. Together, we are working to advance first-in-class targeted cancer...
-
Director, Clinical Pharmacology
2 days ago
, MS, United States Immunovant, Inc. Full timeOrganizational Overview: Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Role: The Clinical...
-
Waltham, MA, United States GlaxoSmithKline Full timeSite Name: Durham Blackwell Street, Upper Providence, WalthamPosted Date: Nov 13 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human...
-
Senior Manager, Clinical Pharmacology
2 days ago
Waltham, MA, United States Deciphera Pharmaceuticals, Inc Full timeDeciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by...
-
Clinical Pharmacology, Modeling and Simulation
3 months ago
Billerica, MA, United States Parexel International Corporation Full timeParexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally!We currently havetremendous opportunities available to join this extremely collaborative and super friendly team! If you're looking for an opportunity to...
-
South San Francisco, CA, United States IDEAYA Biosciences Full timeWhat you’ll do: Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development, including authoring clinical protocols, study reports, data analysis (exposure/efficacy/safety) to supporting development and registration of IDEAYA products. One of the key roles of this position is to apply...
-
Associate Director of In Vivo Pharmacology
2 days ago
Piscataway Township, NJ, United States Tbwa ChiatDay Inc Full timeAssociate Director of In Vivo Pharmacology Piscataway, New Jersey, United States Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including...
-
Director, Clinical Pharmacology
2 days ago
Durham, NC, United States IQVIA Argentina Full timeThis position is Full-Time and Remote-based anywhere in the United States or Canada. Why DSSS? Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global...
-
Billerica, MA, United States Parexel International Corporation Full timeParexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally!We currently havetremendous opportunities available to join this extremely collaborative and super friendly team! If you're looking for an opportunity to...
-
Collegeville, PA, United States GlaxoSmithKline Full timeSite Name: Durham Blackwell Street, Upper Providence, WalthamPosted Date: Nov 13 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human...
-
Associate Director, Clinical Pharmacology
3 days ago
Lincoln, NE, United States Allergan Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...
-
Scientific Associate Director, GI, Inflammation,
1 month ago
Boston, MA, United States Takeda Pharmaceutical Full timeBy 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 information I submit in my employment application is true to the best of my knowledge. Job...
-
Scientific Associate Director, GI, Inflammation,
3 weeks ago
Boston, MA, United States Takeda Pharmaceutical Full timeBy 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 information I submit in my employment application is true to the best of my knowledge. Job...
-
Expert/Director of Preclinical Research
4 weeks ago
Boston, MA, United States Qilu Pharmaceutical Full timeJob responsibilities:Deeply understand the development goals and clinical value orientation of the project, as well as competition/clinical research/supervision/intellectual property/transformation and other cross-professional collaborative research needs, and deeply analyze the competition in the field of disease and positioning strategy of the project from...
-
Boston, MA, United States Takeda Full timeJob Description About the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible to bring life-changing therapies to patients worldwide. Join...