Our client is a growing oncology-focused biopharmaceutical company that is dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products. It has an exciting and well-balanced pipeline of anti-cancer agents being tested in late stage clinical development. The company is currently seeking a talented, dedicated, and collaborative Associated Director of Clinical Pharmacology to join their team in Boston, USA.
- Develop and execute oncology-specific modeling and simulation strategy for both small and large molecule anti-cancer compounds from pre-IND to regulatory submission.
- Work closely with other scientific leaders to shape and expand the current and future portfolio in developing effective oncology agents.
- Contribute to the planning of integrated safety/efficacy/PK studies and the execution in the analysis and interpretation of data throughout clinical development.
- Analyze PK and PD data, and perform modeling and simulation.
- Participate in the writing of clinical pharmacology sections of all regulatory and clinical documents including Investigator Brochures, protocols, summaries, and submissions. Take a lead role in writing and reviewing PK/PD queries from regulatory agencies.
- Provide PK/PD expertise to the program and project teams.
- Interact with CRO's to coordinate, design and monitor population PK and Exposure-Response analyses.
- Represent the company as a PK/PD expert. Critically review and edit CRO PopPK reports, analyze and interpret data (e.g., Clinical Pharmacology and Pharmacometrics) and coordinate report finalization.
- Interact with regulatory agencies with a focus on PK/PD matters.
- Contribute to the scientific society with external presentation and peer-reviewed publication.
- Maintain a current understanding of the literature and leading edge knowledge in the modeling and simulation field, and the trend in the oncology drug development.
Education, Skills and Experience:
- PhD in Pharmacokinetics, or related field.
- Minimum of 5 years of experience in working in the pharmaceutical/biotechnology industry with an emphasis on pharmacokinetics and PK/PD modeling.Â
- Experience in both small and large molecule development for anti-cancer indication and combination therapy is highly preferable.
- Extensive PK/PD and population PK/PD modeling experience using NONMEM, S-Plus, R, WinNonlin, Phoenix/NLME, PLT, PsN, ADAPT
- Hands-on experience with Pharsight clinical trial simulator, Monolix, MATLAB
- Skilled in statistical analysis (SAS, SigmaPlot)
- A proven record of scientific contribution in the field with peer-reviewed publications.
- Experience in choosing, guiding, monitoring, and reviewing CRO study is preferable.
- Ability to synthesize and interpret diverse and multidisciplinary data sets.
- Experience in participating drug development teams and IND/NDA submissions.
- Thorough knowledge with FDA and ICH guidance documents including GLP regulations.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matt Tong on +1 646 768 9726 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.