Director, Pharmacometrics

United States Digital Space LLC; United States; Hybrid; USD 180,000 - 270,000; Full time

Benefits offered by this job

Remote/Hybrid work

Mentoring opportunities

Professional development budget

Leadership opportunities

Competitive salaries

Job summary

United States Digital Space LLC is seeking a Director, Pharmacometrician to lead population PK analyses and shape strategies in a CPMS setting. You will mentor pharmacometricians and guide clients through high-stakes regulatory interactions, driving innovation in modeling and simulation across drug development programs.

This role demands 10+ years in pharmacometrics, strong NONMEM/Pirana/R experience, and proven leadership with a client-focused mindset in fast-paced environments.

Qualifications

• 10+ years of experience in drug development and pharmacometrics.
• Regulatory experience including regulatory report writing and submissions.
• Strong leadership, client-facing skills and ability to drive strategic pharmacometrics programs.

Responsibilities

• Lead population PK analyses using advanced modeling tools and methodologies.
• Develop innovative approaches to enhance PK analysis efficiency and accuracy.
• Design, analyze, and interpret clinical pharmacology studies and provide guidance for PK sampling and dosing strategies.
• Provide strategic guidance to clients and own deliverables.
• Author and review PK reports and regulatory sections.

Skills

NONMEM

Pirana

R

Education

Life science degree

Tools

Pirana

NONMEM

R

Job description

Step into a role where science meets strategy and your expertise shapes the future of drug development. As a Director, Pharmacometrician, you’ll lead high-impact modeling and simulation efforts within a dynamic Clinical Pharmacology, Modeling and Simulation (CPMS) environment. You’ll guide teams, mentor pharmacometricians, and provide strategic insight to clients at key development milestones. This role also offers the opportunity to represent clients in interactions with regulatory agencies. If you thrive on collaboration and solving complex scientific challenges, this is your chance to make a meaningful impact.

About the role

This role combines scientific leadership and strategic impact, leading population PK analyses while developing innovative approaches to improve efficiency and accuracy. You will design, analyze, and interpret clinical pharmacology studies, provide strategic guidance to clients, and contribute to regulatory documents and agency interactions. In addition, you’ll foster client relationships, support business development, and stay at the forefront of PK/PD advancements to drive continuous improvement.

Your main responsibilities will include but not limited to:

• Lead and conduct population PK analyses using advanced modeling tools and methodologies
• Develop and implement innovative approaches to enhance the efficiency and accuracy of PK analysis
• Design, analyze, and interpret clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance tooptimizepharmacokinetic sampling and dosing strategies
• Provide strategic guidance to clients, owning deliverables and developing clinical pharmacology plans
• Author and review PK reports and clinical pharmacology sections of regulatory documents
• Represent clients in regulatory interactions and contribute to business development and relationship managementRequirements

About You

If you are a driven clinical pharmacology professional with 6–10 years of experience in drug development and pharmacometrics and you bring sharp analytical thinking and expertise in tools like NONMEM, Pirana, and R to deliver high-impact insights while being client-focused and a natural leader who thrives in fast-paced environments, combining strategic thinking, strong communication, and business acumen to build relationships and drive results, this role is for you.

To be successful we are looking for the following traits and behaviors:

• Life science, healthcare and/or business degree
• Minimum 10 years of relevant work experience, including experience in drug development, clinical pharmacology, and pharmacometrics
• Regulatory experience including regulatory report writing essential. Experience with regulatory submissions including INDs, CTAs, regulatory meetings and NDA/BLA/MAA submissions
• Proficiency in NONMEM,Pirana, and R software preferred
• Excellent organizational, negotiating and financial skills

About the company

Our mission is to help bring new therapies to light. When you work at the company, that means rolling up your sleeves and applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

If you're passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.

Together we SHINE. Find more information about our values.

Benefits of working at the company include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our enriching Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within a reasonable distance from one of our global offices.