Shire DMPK Lead (Associate Director) in Lexington, Massachusetts
The Associate Director will be responsible for providing overall DMPK strategy to support One Shire Research and Development in all therapeutic areas from discovery, early development, clinical development to post-approval/commercialization. Key responsibilities include providing expertise in pharmacokinetics (PK), pharmacodynamics (PD), and physiologically based PK (PBPK) modeling and simulation strategy that advance project and program goals. The individual will be responsible for translational PK/PD expertise for candidate nominations and development, generating supportive nonclinical and clinical PK studies and reports, drug-drug interaction simulations and clinical guidance, clinical study reports (CSRs) and relevant sections of Regulatory filings. The AD will provide Subject Matter Expertise for regulatory agency interactions and to make recommendations on business development opportunities. The individual will work closely with nonclinical and clinical colleagues to generate integrated study designs and plans leading to approval of clinical dose regimens for novel therapeutics in all patient populations. The individual will represent DMPK, and as NCD lead all nonclinical aspects, on EDT and GDT programs. Furthermore, the individual will liaise between DMPK, NCD, Research, Translational Medicine, Clinical Pharmacology, Clinical Operations, Clinical Research, Program Management, CMC, Process Development, Biometrics, Regulatory Affairs, Business Development and Commercial.
Responsibilities (% of time)
Serve as an interdisciplinary program team representative and liaison between NCD and Clinical / Medical, CO, RA, PM and PD / Manufacturing functional areas
Responsible for generation of DMPK strategy and execution on all aspects of nonclinical discovery and development programs to meet business objectives
Responsible for designing, executing, analyzing, summarizing, interpreting and reporting results of DMPK studies and guidance on development, clinical and regulatory strategy
Mentor junior scientists to support career development and maximize DMPK talent and capability
Integrate data across functional areas using standard and innovative methods, to optimize/predict/rationalize clinical dose and regimen, refine study designs and facilitate lifecycle management using accepted and novel tools/methods, e.g., WinNonLin, NONMEM, SAS, LIMS, Simcyp
Propose/develop and execute on novel initiatives (e.g., modeling/simulation, informatics), to expand the functional capabilities of the group and/or address current or anticipated research needs.
Manage external collaboration(s) with experts in relevant disciplines to utilize / develop new methodologies to support the portfolio as well as individual development programs.
PharmD or PhD in appropriate field with clinical pharmacology, PK/PD and PBPK modeling and simulation training.
Seven or more years post-graduate experience in industry, regulatory or academic environments in clinical pharmacology, PK/PD and PBPK disciplines.
Experience with both small and macromolecular/biologic drugs is highly desirable.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.