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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Cambridge, Massachusetts
job type: Contract
salary: $175 - 250 per hour
work hours: 8 to 4
The Senior Director of Clinical Pharmacology & Pharmacometrics serves as the Disease Area Portfolio Lead overseeing several clinical development or program teams providing strategic leadership and execution of clinical development plans from Phase 1-Phase 4 programs. This includes characterization and prediction of the pharmacokinetics, pharmacodynamics, efficacy of drug candidates into a Model-Informed Drug Development (MIDD) framework. This person also provides rationale for dose regimen selection, clinical study design, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. The Senior Director also serves as a manager/mentor Clinical Pharmacologists up to Director level and manages Clinical Pharmacology resource internally and externally across programs.
- Leads and manages high profile clinical pharmacology activities including training, CDP and study designs with R&D across drug modalities and Biogen disease areas
- Leads Disease Area Portfolio including several drug modalities
- Drives the development and execution of the Clinical Pharmacology Strategy and Plan of several clinical development and/or program teams. Provides key components of the Early Development Plan, advises teams on Clinical Pharmacology Strategy and science and provides input to line management. Works with clinical development and/or program teams to achieve program goals and provide deliverables in approved timeframes.
- Leads clinical pharmacology efforts in early and late stage (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, data analysis, and reporting) within assigned programs to yield high value PK/PD insight for critical decisions. Analyzes results, interprets, and recommends action based on study results.
- Ability to represent clinical pharmacology function at governance (DPAC, RDGC, TRC) and external advisory boards
- Provides extensive regulatory strategy expertise for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents. Maintains cutting edge knowledge of best regulatory practices, Clinical Pharmacology technology and drug development precedent.
- Engages in cross-functional activities providing Clinical Pharmacology input and provides a source of Clinical Pharmacology expertise and advice to other functions across the Company. Participates in and provides Clinical Pharmacology perspective to cross-functional committees and activities.
- Maintains extensive scientific awareness and presence in Clinical Pharmacology, publishes multiple manuscripts and posters, presents at Scientific Conferences and other scientific forums. Engages with consultants and advisors in the field, as well as the scientific community at large.
- Manages and/or mentors junior staff within the function and matrix leadership across projects. Develops expertise in highly specialized and/or novel aspects of Clinical Pharmacology and serves as a reference source in these for his peers.
- Ph.D., M.D., or Pharm.D. in Clinical Pharmacology, pharmacokinetics, or a related field
- Experience with use of PK/PD software packages such as -Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS
- 12+ years of direct industry experience in Clinical Pharmacology & PPDM.
- Experience in leading teams and/or managing professional staff.
- International recognized expert in Quantitative Clinical Pharmacology
- Solid experience in developing Clinical Pharmacology strategy, designing/implementing Clinical Pharmacology studies
- Excellent knowledge of the principles of Clinical Pharmacology and PPDM
- Demonstrates strong team work in a multidisciplinary environment
- Strong knowledge of the drug development process and overall familiarity with the regulatory process. Direct experience in preparing regulatory submissions and responding to health authority questions.
- Extensive record of publications, presentations, invited lectures, and other scientific activities
- Active knowledge of advanced methods for Quantitative Pharmacology and PMx analyses
skills: Pharmacology, Phase I, Phase II, Phase iii, Phase iv, Drug Safety
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.