Senior Director of Pharmacometrics

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Full time
Location: Cambridge
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Job offered by: Software Placement Group
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Senior Director of Pharmacometrics We are seeking an experienced Senior Director of Pharmacometrics to lead our modeling and simulation efforts in drug development. This senior leadership role focuses on the application of pharmacometrics in the translational and clinical development phases, enhancing our capabilities in predictive modeling of pharmacokinetics (PK), pharmacokinetics/pharmacodynamics (PKPD), and statistics. The successful candidate will bring a wealth of international drug development experience and a deep understanding of regulatory frameworks, capable of driving strategic M&S activities across our portfolio with a focus on optimization and innovation. Salary:

DOE per year Essential Duties and Responsibilities: Provide visionary leadership in the integration of pharmacometrics with drug development processes. Design and implement advanced PK and PKPD modeling and simulation strategies. Steer the pharmacometric aspects of international regulatory submissions, including writing and face-to-face interactions with regulators. Publish research findings and represent the company at international scientific forums to enhance our scientific standing. Lead cross-functional teams, fostering collaboration between clinical pharmacologists, statisticians, and other departments. Develop strategic M&S activities that align with company’s objectives and portfolios. Minimum Position Qualifications: PhD degree in a relevant field such as Pharmacometrics, Pharmaceutical Sciences, or Statistics; M.Sc./Pharm.D. with extensive relevant experience will also be considered. Minimum of 10 years of experience in international drug development, including significant roles in both early and late-stage projects. Proven track record of impact in pharmacometrics, evidenced by a history of scientific publications and presentations. Proficient in usage and application of software and tools used in M&S (e.g., NONMEM, Monolix, R, MATLAB). Thorough knowledge of regulatory requirements and processes internationally, with specific experience in major markets such as the USA, EU, and Japan. Preferred Qualifications: Experience with innovative trial designs facilitated by pharmacometric analyses. Leadership positions held in international pharmacology or clinical pharmacology societies. Demonstrated ability to mentor junior scientists and develop an effective team. Skills: Strong analytical and problem-solving skills specific to pharmacometrics. Exceptional communication skills, including the ability to present complex data to non-expert audiences. Advanced proficiency in statistical programming and modeling software. Effective leadership and interpersonal skills, with a demonstrated ability to manage and motivate a team. Benefits: Competitive salary and performance bonuses. Comprehensive health insurance including dental and vision plans. Generous retirement plan. Support for continuous learning and professional development. Paid leave for personal and family wellness.

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