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Sr. Manager, Clinical Pharmacology
900 Winter St Waltham, MA 02451 US
Job Description
We have an exciting opportunity for a highly motivated and experienced quantitative clinical pharmacologist to join our team supporting CNS therapeutic area as a key member of Clinical Pharmacology, DMPK and BA department. He/she will represent as a Clinical Pharmacology Lead and provide subject matter expertise on cross-functional project teams.
This position will have a core scientific responsibility of selecting optimal doses and dosage regimens inpatients, and will integrate the knowledge of clinical PK, clinical PK/PD, healthy volunteer phase 1 study, and drug development. This role will provide the opportunity to support multiple programs through participation on internal project working teams and serves as a liaison between chemistry, life sciences, regulatory and clinical operations. Hands on modeling experience is desirable.
Essential Areas of Responsibility:
·Contributing to clinical program design, trial protocols, analysis plans, and study reports
·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
· Ability to function in a highly matrixed team environment
A strong background in clinical pharmacology, pharmacokinetics and modeling combined with excellent leadership and communications skills are essential in this dynamic role. 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. Knowledge of, and immediate experience in CNS therapeutics is desired.
The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members. Upon completion of on-boarding, this person will be 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.
Requirements:
·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.
· Knowledge: 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.
·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.
·Excellent interpersonal, leadership, communication and time-management skills are essential; demonstrated direct management of internal and external personnel (outsourced projects) is required.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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