Clinical Manager Clinical Pharmacology (CNS)

SRG, the leader in the Life Sciences human capital industry, is looking for a Clinical Manager Clinical Pharmacology (CNS) to join our team in Waltham, Mass.

Onsite/Hybrid: Waltham, Mass (onsite 3 days per week)

Contract: 7 months

Qualifications & Skills:

• A strong background in clinical pharmacology, pharmacokinetics and modeling combined with excellent leadership and communications skills are essential in this dynamic role.
• Education: 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.
• PK Experience: The incumbent should have a strong understanding of pharmacokinetic theory, compartmental modeling and simulation, and statistical approaches utilizing the latest computational approaches and tools.
• 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.
• Regulatory: 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.
• Writing: 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.
• 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 are desirable attributes.
• Relied upon to act independently, within a highly matrixed clinical development organization and must have the experience and conviction to provide sound clinical pharmacology related input to the project teams.

Responsibilities:

• 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 modelling
• 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

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.