AD/Director of Clinical Pharmacology
We are seeking a motivated Associate Director/Director of Clinical Pharmacology to lead strategic clinical pharmacology initiatives for a mid-size biotechnology company focusing on oncology therapies. Key responsibilities: Develop and execute clinical pharmacology strategies for the company's pipeline. Design and lead clinical pharmacology study design and analysis for Phases 1-3. Assist with Pharmacometrics applications. Act as a SME during regulatory interactions and submissions. Oversee external CRO management. Qualifications PharmD or PhD in Pharmacology, Pharmaceutical Sciences, or a related field. 5+ years of industry experience in Clinical Pharmacology. IND/NDA/BLA experience. Hands on expertise with software such as Phoenix WinNonLin, NONMEM, R.
US$180000 - US$200000 per year
United States of America
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Associate Director of DMPK
I am partnered with a growing biotech company located in San Francisco who is looking for an Associate Director of DMPK to join their team! This company currently has 8 candidates in their preclinical pipeline and 2 clinical candidates across metabolic, neuro, ophthalmology, and cardio areas. This is an exciting opportunity to become a DMPK representative and work with the DMPK and cross-functionally at a closely collaborative, and fast paced company. Role: Lead all small molecule discovery efforts for the DMPK team Collaborate cross-functionally with multiple teams withing the company to design and execute studies directly targeted toward DMPK questions and relationships. Manage relationships between company and CRO for selected studies Mentor scientists and eventually build out your own team of DMPK Scientists Requirements- PhD with 6 years of industry experience Small molecule background on the discovery side of DMPK Prior experience with human PK predictions and PK Modeling using WinNonLin Study design and data interpretation experience for DMPK studies LCMS experience is a plus
US$185000 - US$225000 per year
San Francisco
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Director/Senior Director of Pharmacometrics
Join a dynamic, fast-paced biotechnology company based in South San Francisco dedicated to advancing oncology therapies! We are seeking a highly skilled and experienced Director/Senior Director of Pharmacometrics to contribute to the success of the company's drug development programs. Responsibilities: Develop and implement pharmacometrics methodologies to support drug discovery. Drive clinical pharmacology and pharmacometrics strategies across the clinical development pipeline. Collaborate cross-functionally with clinical development, DMPK, and other relevant departments. Contribute to preparation of regulatory documents (INDs, NDAs, etc.) Manage external CROs to support pharmacometrics analyses and timelines. Qualifications: PhD or PharmD with 10 years of relevant industry experience in Clinical Pharmacology and/or Pharmacometrics. Extensive experience with PopPK exposure-response analysis. Hands-on expertise with software such as NONMEM, R, Phoenix WinNonLin, and other similar tools.
US$220000 - US$270000 per year
San Francisco
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Director, DMPK
We have a current opportunity for a Director, DMPK on a permanent basis. For further information about this position please apply. As the Director of DMPK, you will supervise ADME scientists locally in Boston who provide drug discovery and development support for our diverse portfolio including; small molecules, biologics, nano-medicines and PROTACs. In addition, the selected individual will also have the opportunity to provide input into drug discovery and development across the global Oncology portfolio. Responsibilities: Supervising and managing a team of ADME scientists by mentoring and challenging them, as well as providing expert advice and context for the interpretation of complex data. Developing and implementing state-of-the-art technologies in the field of drug metabolism and transporters. Leading DMPK-related compound design activities to ensure project ADME challenges are thoroughly assessed and resolved from HTS work-up to candidate nomination through risk mitigation and/or structural modification. Applying an expert understanding of DMPK, physico-chemical property assays and/or biotransformation reactions to discovery project chemistry and data. Requirements: PhD or equivalent degree in Pharmaceutical Sciences, Molecular Biology, Chemistry, Biochemistry or Pharmacology with experience in drug discovery, or a higher degree in a research area relevant to DMPK science. At least 8+ years of relevant industry experience in ADME/Project Representation or a MS degree with at least 13+ years of relevant industry experience. Strong technical knowledge of DMPK science with a proven ability to delineate the impact of chemical structure on measured properties.
£200000 - £220000 per year
Massachusetts
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Director/Sr. Director, Clinical Pharmacology and PMx
We are partnered with a growing precision medicine oncology biotechnology company based in San Francisco on an exciting Director/Senior Director opportunity! You will be providing guidance on all Clinical Pharmacology related programs such as authoring protocols, CSRs, data analysis, etc. A key role in this position is to provide PK/PD modeling and simulation expertise, especially PopPK exposure-response analyses. Requirements: PhD in Pharmaceutical Sciences or a related field, or PharmD 10 years of industry experience in Clinical Pharmacology, or related field Hands-on Pharmacometrics experience using software like NONMEM, R, Python, etc. Experience managing or collaborating with external CROs
US$280000 - US$310000 per year
San Francisco
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Quality Assurance Project Manager
We are currently searching for a QA Project Manager for one of our clients, a global bio-pharmaceutical company located in Switzerland. As the QA Project Manager, you will play a crucial role in providing daily oversight, tactical, and strategic leadership for a team of QA Project Managers supporting both internal and external customers. Your key responsibilities will include: Providing general leadership, guidance, and support to ensure QA Project Managers meet key milestones during tech transfer, process validation, material assessments, and other critical areas. Ensuring staff meets QA objectives on time and in full compliance, including addressing issues related to tech transfer, process validation, deviations, change controls, regulatory compliance, and quality agreements. Leading the identification, defense, and resolution of Quality issues with necessary decision-making and supporting documentation. Setting the model for superior customer service, acting as a point of escalation for QA staff and customers. Overseeing training, mentorship, and development in Quality principles. Conducting objective setting and regularly scheduled sessions with team members for feedback and guidance. Serving as the QA Project Manager for a client project when required. More Specific Duties: Quality deliverables (e.g. sterility assurance assessments) are met for key milestones during tech transfer (TT) and process validation, material assessments, issues related to tech transfer are addressed and brought to resolution, process validation execution, TT production issues, deviations, change controls, regulatory compliance issues, quality agreements, and mange and track key Performance Indicator metrics for internal and external customers. Supporting the site as senior QA on higher risk change controls and Deviations from the areas of MSAT, Engineering, QC, Validation, SC, and Manufacturing. For further information about this position, please apply with your CV. *Please note, only those with the right to work in Switzerland can apply!
Negotiable
Schweizer-Reneke
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