Sr. Manager, Clinical Pharmacology

Peak Performers has partnered with a global pharmaceutical company to assist in their search for a hybrid Sr Manager, Clinical Pharmacology in Waltham. MA . In this contract position, you will have a core scientific responsibility of selecting optimal doses and dosage regimens inpatients, and will integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical PK (ADME and DMPK).

Major duties

• Contributing to clinical program design, trial protocols, analysis plans, study reports and regulatory submissions
• Conducting and overseeing pharmacokinetic (NCA)analysis, exposure-response analysis, simulation-based trial design and dose selection, and population clinical pharmacology modeling
• Presenting strategy and defending outcome of model-based approaches to internal governance boards and regulatory agencies
• Write or review clinical pharmacology components of regulatory documents and responses as well as participate directly in regulatory interactions
• Promoting model-informed drug discovery and development through external collaboration, journal publication and conference presentation
• Ability to function in a highly matrixed team environment
  
  

What are we looking for?

• A strong background in clinical pharmacology, pharmacokinetics and modeling combined with excellent leadership and communications skills
• Clinical pharmacology experience with small molecule in a variety of clinical investigation paradigms is desired.
• Direct experience with pharmacokinetic/pharmacodynamic modeling, bioanalytical analysis, and nonclinical ADME
• Ph.D. or Pharm D in Pharmaceutical Sciences, Pharmacometrics, or related field with 3 years or 4 years of experience in pharmaceutical industry.
• Demonstrated experience in serving as clinical pharmacology lead on development programs.
• Strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.
• Sound working knowledge of the cross-function interfaces that are important for efficient drug development, and a detailed understanding of non-clinical and clinical DMPK processes.
• Programming experience (Phoenix) is must; other programming experience (e.g., , Monolix, R, WinNonlin, SAS, Splus) is desirable.
• Current knowledge of FDA regulatory guidance related to nonclinical and clinical pharmacology; experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
• Experience in non-compartment and model-based PK and PK/PD analyses and inclusion of data in the preparation of manuscripts, study reports and sections of regulatory submission documents(e.g.: INDs, NDAs, CTDs) is required.
• Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
  
  

Exciting Opportunity Details

• Rate: $95.00/hour
• W2 Contract
• Worksite Location: Waltham, MA
• Hybrid- 3 days onsite
• 6 month contract
  
  

The Peak Performers difference

• Excellent medical health, dental & vision insurance at 60 days
• Our employees may choose to participate in a 403(b) retirement plan
• Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
• We pay weekly through direct deposit
• In business since 1994 and thousands of job placements
  
  

All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws.

Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.

Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.

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