Director â Pharmacometrician
Director â Pharmacometrician
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Job Description
Job Title: Director Pharmacometrician
Company Overview:
Pulivarthi Group is a premier global provider of staffing and IT technology solutions renowned for delivering exceptional services tailored to each clients unique needs. With a steadfast commitment to excellence we merge expertise with innovation ensuring cost-effective solutions of the highest quality. Our diverse client base spans healthcare finance government and beyond reflecting our adaptability and proficiency across industries. Operating in the United States Canada and Mexico we pride ourselves on aligning with clients cultures deploying top-tier talent and utilizing cutting-edge technologies. Pulivarthi Group stands as a beacon of reliability efficiency and innovation in the realm of staffing solutions.
Job Overview/Summary:
We are seeking an experienced Director Pharmacometrician to provide pharmacometric expertise and leadership across multiple drug development projects. This role will be instrumental in developing and implementing Model-Informed Drug Development (MIDD) strategies leading complex quantitative analyses supporting regulatory submissions and mentoring team members. The successful candidate will act as a Subject Matter Expert (SME) for pharmacometrics advancing quantitative methods tools and best practices across the organization.
Responsibilities:
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Lead the development and implementation of Model-Informed Drug Development (MIDD) plans across projects and therapeutic areas.
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Conduct and report quantitative analyses integrating pharmacokinetics pharmacodynamics patient characteristics and disease state data to optimize doses regimens and study designs.
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Identify opportunities where modeling and simulation can advance understanding of pharmacological activity efficacy and safety.
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Act as SME for pharmacometrics supporting and developing quantitative methodologies software automation hardware tools and business processes.
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Provide leadership and support for preparation and defense of regulatory submissions including responses briefing documents and presentations.
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Develop and maintain automation tools improving the efficiency of pharmacometric analyses communication and decision making.
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Prepare high-quality presentations and written reports to organizational and regulatory standards.
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Stay current with literature government guidelines and internal guidance related to pharmacometrics and MIDD.
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Promote educate and mentor others in quantitative techniques MIDD best practices and share experiences through internal and external forums.
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Produce and present quality scientific contributions at external meetings and in peer-reviewed publications.
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Contribute to or lead the development and improvement of internal tools processes and methodologies including external collaborations consortia and academic relationships.
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Support IT colleagues and data flow infrastructure to ensure best-in-class support services for systems and software tools.
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Deliver internal training on quantitative tools methodologies and related processes.
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Train develop and mentor junior Pharmacometricians or Clinical Pharmacology colleagues.
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Participate in multidisciplinary teams including assessment of potential in-licensing opportunities and engagement with external key opinion leaders or regulatory authorities.
Primary Skills:
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Expertise in pharmacostatistical modeling and Model-Informed Drug Development (MIDD).
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Strong knowledge of pharmacokinetics pharmacodynamics pharmacology pharmaceutics and/or statistics.
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Proficiency with MIDD software (R NONMEM STAN or equivalent).
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Demonstrated leadership and mentoring skills within a scientific environment.
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Strong scientific writing and presentation skills.
Secondary Skills (Good to Have):
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Familiarity with biology physiology/pathophysiology and drug research & development processes.
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Experience developing automation tools or data infrastructure for pharmacometric analyses.
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Experience collaborating with regulatory authorities and presenting at scientific meetings.
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Ability to influence cross-functional teams and key opinion leaders.
Qualifications:
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Pharm.D. Ph.D. or equivalent advanced degree in pharmacometrics pharmacokinetics clinical pharmacology statistics or related discipline.
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At least 5 years of experience in pharmacostatistical modeling and application of MIDD.
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Candidates from mathematics engineering systems biology or medicine backgrounds will be considered if relevant expertise is demonstrated.
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Strong computational skills and working knowledge of MIDD software tools.
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Excellent communication skills (written verbal presentation).
Benefits/Perks:
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Competitive executive-level compensation package.
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Comprehensive health dental and vision insurance.
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Paid time off sick leave and company holidays.
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Professional development leadership training and conference opportunities.
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Opportunities to shape and lead cutting-edge pharmacometric strategy within a global organization.
Equal Opportunity Statement:
Pulivarthi Group is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive culture and celebrate authenticity. We do not discriminate on the basis of race religion color national origin gender gender identity sexual orientation age marital status disability protected veteran status or any other legally protected characteristics.
Employment Type
Full-time
