Associate Director, Clinical Pharmacology

Celgene

(Summit, New Jersey)
Full Time
Job Posting Details
About Celgene
Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.
Responsibilities
* Assume (with guidance) strategic responsibility for the Clinical Pharmacology components of development from development candidate nomination through lifecycle management post approval. * Contribute to early compound development by generating an Early Drug Development Plan before compounds enter Phase I --, revising and updating later as appropriate. * Share cross-functional responsibility for assessing safety, tolerability, and pharmacokinetics (PK) in study participants, Help identify and address cross-functional issues. * Contribute to regulatory filings and dossiers;, maintain currency of program reporting requirements (e.g., safety updates, annual reports). Collaborate with counterparts in regulatory agencies. * Develop awareness of external science, as well as liaisons with external scientists to advance drug development. * Exhibit scientific leadership in applying clinical pharmacology to drug development, including the following. * Design, plan, execute, and report high quality Clinical Pharmacology studies -- in collaboration with Statistics, Operations, Regulatory Affairs, and Quality Assessment colleagues. * Design, plan, and execute pharmacodynamics trials to show proof of activity and measure PK-PD relationships , using endpoints including imaging, questionnaires, or molecular assays -- in collaboration with Discovery, Pharmacokinetics, Translational Medicine and Clinical colleagues. * Collaborate with the trial pharmacokineticist in designing and interpreting PK models, and in interpreting PK-PD data to aid in Phase 2 dose selection. * Embrace continuous improvement to advance development of new medicines. This includes professional and scientific learning, contribution to process improvement, and utilization of the latest clinical research approaches * Effectively represent Clinical Pharmacology in both intra- and extra-departmental activities (e.g., Project Teams). * Show potential to direct others in the science and operations of clinical pharmacology in drug development. Though the position is initially intended as that of an individual contributor, later acquisition of a managerial role is encouraged.
Ideal Candidate
- MD degree. - Board certification in a medical specialty. - 2+ years of focused research experience in human trials, bench experimentation, or epidemiology. - Conversational familiarity with biomedical science outside of research specialty. - Strong verbal and written communication skills. - Desire and demonstrated ability to collaborate. - Flexibility and a desire to undertake multidisciplinary research. - Ability to live in the Northeast United States.

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