Job Description

We have a current opportunity for a Senior Director Quantitative Clinical Pharmacology and Pharmacometrics Role on a permanent basis. The position will be based in Massachusetts. For further information about this position please apply.

Job Title: Senior Director, Quantitative Clinical Pharmacology and Pharmacometrics

Job Type: Full-time

Salary: 260,000 - 300,000 base salary + additional benefits

Job Summary: The Senior Director of Quantitative Clinical Pharmacology and Pharmacometrics will lead the development and implementation of quantitative strategies to support drug development and regulatory submissions. This is highly visible, team-facing and leadership position that will partner closely with two other groups within QCP, Translational Pharmacology, QSP and Data Analytics, as well as cross-functionally across the R&D organization.

Key Responsibilities:

• Leadership and Management: Lead clinical pharmacology and pharmacometrics teams, providing technical guidance and fostering a collaborative environment.
• Strategic Planning: Develop and implement quantitative strategies for clinical pharmacology and pharmacometrics to impact pipeline decisions and regulatory submissions.
• Model-Based Analyses: Oversee the development and execution of model-based analyses, including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, and clinical trial simulations.
• Collaboration: Work closely with cross-functional teams, including clinical development, regulatory affairs, and biostatistics, to ensure alignment and integration of quantitative strategies.
• Regulatory Submissions: Prepare and review clinical pharmacology sections of regulatory submissions, ensuring compliance with regulatory requirements and guidelines.
• Innovation: Drive scientific innovation by incorporating novel and creative approaches to quantitative clinical pharmacology and pharmacometrics.
• Stakeholder Engagement: Represent the function in interactions with internal and external stakeholders, including regulatory agencies, key opinion leaders, and industry groups.

Qualifications:

• Education: Ph.D. in Pharmacokinetics, Pharmacodynamics, Pharmacometrics, Clinical Pharmacology, or a related field.
• Experience: Minimum of 10 years of industry experience in quantitative clinical pharmacology and pharmacometrics, with a proven track record of successful regulatory submissions.
• Technical Skills: Expertise in modeling and simulation, PK/PD, systems pharmacology, and quantitative drug development strategies | NONMEM
• Leadership Skills: Strong leadership and management skills, with experience in guiding and mentoring teams.
• Communication Skills: Excellent written and verbal communication skills, with the ability to effectively present complex scientific concepts to diverse audiences.
• Collaboration: Demonstrated ability to work collaboratively in a cross-functional environment and influence stakeholders at all levels.
• Innovation: Proven ability to drive scientific innovation and incorporate novel approaches into quantitative strategies.

Benefits:

• Comprehensive health, dental, and vision insurance
• Retirement savings plan with company match
• Paid time off and holidays
• Professional development opportunities
• Flexible work arrangements

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