SR. MANAGER/ASSOC DIR, CLINICAL PHARMACOLOGY

SR. MANAGER/ASSOC DIR, CLINICAL PHARMACOLOGY Job Description:Company Information:Breakthrough Careers!A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.Position Summary:The clinical pharmacologist designs, analyzes, interprets and reports clinical pharmacokinetic and PK/PD elements of oncology clinical development programs and projects.Duties and Responsibilities:Serve as clinical pharmacologist on oncology drug development projects.Be responsible for the design, analysis, interpretation and reporting of all clinical pharmacokinetic and PK/PD elements of clinical development programs and contribute to their integration into the overall clinical development plan and dossier.Contribute to the design of First-in-Human studies, assessments of drug-drug interactions and food effects, evaluation of pharmacokinetics in special populations, evaluation of effects on QTc, and population PK and PK/PD characterization consistent with Good Clinical Practices and Millennium Standard Operating Procedures.Be at the forefront of scientific literature in the discipline of applied clinical pharmacology, including the pharmacokinetic and PK/PD sciences, human drug metabolism, drug-drug interactions, biopharmaceutics, and pharmacometrics.Maintain current knowledge of the regulatory landscape as it pertains to clinical pharmacologic and biopharmaceutic evaluation in drug development, including issues specific to oncology drugs.Prepare Clinical Pharmacology and Biopharmaceutics elements of summary documents for regulatory submissions and contribute to the preparation and maintenance of Investigator Brochures, external presentations and publications.Qualifications:Basic Qualifications:Doctoral degree in Pharmacology, Pharmacokinetics, Pharmaceutics or related field (Ph.D. or Pharm.D) and minimum of 2-5 years of related experience; Masters Degree with a minimum of 8 years of related experience.Academic and/or pharmaceutical industry experience as a clinical pharmacologist in the oncology therapeutic area is desirable.Strong theoretical background in the pharmacokinetic, PK/PD and drug metabolism sciences.Demonstrated technical hands-on experience and fluency with the use of WinNonlin for noncompartmental PK and PK/PD analysis and reporting in clinical studies with a high level of independence.Understanding of population PK and PK/PD concepts, principles of model-based analyses and their interpretation, and applications in drug development.Preferred Qualifications:Technical hands-on experience with population PK and PK/PD analyses using NONMEM and ancillary tools (e.g., S-PLUS) is desirable but not required.Functional knowledge of Good Clinical Practices and regulatory guidelines relevant to clinical pharmacology issues in drug development.Excellent interpersonal skills, written and oral communication skills, and ability to work in a dynamic cross-functional team-oriented setting.Click here to immediately applyWant to learn more about us? Years of Experience Required: 3-5 YearsExpected Travel Time: None Searchable Keywords: SAS / gj-moExpected Travel Time: None Company: Millennium Pharmaceuticals, Inc. Contact: Recruiter Email: Apply by Email Address: 02454 Reference Code: 14467.26412.5457BR Company: Millennium Pharmaceuticals, Inc. Status: Full Time, Employee Job Category: Biotech/R&D/Science