About the Job: Senior Director Pharmacometrics CPQP We are seeking a Senior Director of Pharmacometrics CPQP to lead our organization's efforts in clinical drug development through cutting-edge modeling and simulation practices. This role is pivotal in translating complex biological processes into tangible drug development strategies within a global setting. The successful candidate will drive the development and application of pharmacometric models (PK/PD), implement regulatory strategies, and mentor a team of experts to enhance our portfolio of drug development projects. This position offers the opportunity to impact our long-term vision and directly contribute to advancements in healthcare.
Compensation: DOE
Essential Duties and Responsibilities: Lead and expand the use of pharmacometric models, including population PK, PK/PD modelling and simulation, throughout the drug development lifecycle. Strategically implement modeling and simulation techniques to support clinical study designs, dose selection, and regulatory submissions. Facilitate cross-functional collaborations to integrate pharmacometrics in translational medicine and clinical pharmacology efforts. Communicate technical results and strategies effectively to non-specialists and senior management. Provide subject matter expertise in key regulatory interactions and documents submissions. Align pharmacometric strategies with therapeutic area program objectives to maximize clinical trial success. Mentor and develop junior staff and build a highly skilled pharmacometrics team. Stay updated with advancements in the field and incorporate innovative methods into practice. Minimum Position Qualifications: PhD in Pharmacometrics, Pharmacy, Medical Sciences, Biostatistics, or a related field. At least 10 years of international drug development experience, with a strong focus on pharmacometrics. Proven experience in using software tools like NONMEM, Monolix or other relevant modelling and simulation software. Demonstrated experience in regulatory strategies and interactions related to pharmacometrics. Strong project management skills, capable of leading multiple projects across different therapeutic areas. Preferred Qualifications: Extensive knowledge and hands-on experience in advanced modeling and simulation techniques. Previous leadership role or senior position in pharmacometrics within a pharmaceutical company. Prior experience in operating under FDA, EMA or other regulatory authority workflows. Track record of peer-reviewed publications in pharmacometrics or related fields. Skills: Exceptional leadership and interpersonal skills to effectively lead and motivate a team. Strong analytical and problem-solving skills paired with a meticulous attention to detail. Excellent verbal and written communication skills, capable of presenting complex data to a variety of audiences. Proactive in staying current with industry trends and emerging technologies in pharmacometrics. Ability to function effectively in a fast-paced, dynamic team environment.
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