Job Description

We have a current opportunity for a Senior Manager - AD Quantitative Clinical Pharmacology on a permanent basis. The position will be based in Cambridge. For further information about this position please apply.

Job Title : Senior Manager, Quantitative Clinical Pharmacology / AD QCP

Job Type : Full-Time

We are a leading mid sized pharmaceutical company dedicated to improving patient outcomes through innovative research and development targeting gene therapy/rare diseases. We are committed to advancing healthcare by developing cutting-edge therapies and solutions.

Job Summary : We are seeking a highly skilled and experienced Senior Manager/AD Quantitative Clinical Pharmacologist to join our dynamic team. This incumbent is responsible for providing translational, clinical pharmacology and pharmacometrics deliverables for development assets from pre-IND to Phase III . The successful candidate will play a critical role in the design, analysis, and interpretation of clinical pharmacology studies, contributing to the development of new therapeutic agents. They will drive and support pharmacology and pharmacometrics activities involved for dose selection and characterizing the interactions between drugs, patients, and biological systems to identify key predictors.

Key Responsibilities :

• Lead the design and execution of quantitative clinical pharmacology studies, including pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation.
• Develop and implement clinical pharmacology strategies to support drug development programs.
• Collaborate with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure the integration of clinical pharmacology data into overall development plans.
• Provide scientific and strategic input into study protocols, clinical study reports, and regulatory submissions.
• Mentor and guide junior scientists in the principles and practices of quantitative clinical pharmacology.
• Stay current with advancements in the field and apply innovative approaches to enhance drug development processes.

Qualifications :

• M.S./Ph.D. or Pharm.D. in pharmacology, pharmaceutical sciences, pharmacometrics, biomedical engineering, statistics, applied mathematics
• Minimum of 3 years of experience in clinical pharmacology, with a focus on quantitative methods.
• Proven track record of leading clinical pharmacology studies and contributing to successful drug development programs.
• Strong expertise in PK/PD modeling and simulation software (e.g., NONMEM, Phoenix WinNonlin).
• Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment.
• Demonstrated ability to think critically and solve complex problems.

Benefits :

• Competitive salary and performance-based bonuses.
• Comprehensive health, dental, and vision insurance.
• Retirement savings plan with company match.
• Opportunities for professional development and career advancement.
• Flexible work arrangements and a supportive work-life balance.

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