Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include over 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. We aim to enable the life sciences industry’s use of data, modeling, and analytics to enhance decision-making throughout the drug development phases.

The Role

As a Senior Director, you will lead teams and serve as the subject matter expert for specific company offerings, managing major client accounts and business areas autonomously. You will ensure efficient delivery of business offerings, manage project teams, and cultivate client relationships while driving new business opportunities.

Responsibilities

• Lead multidisciplinary teams in the design, execution, strategy, and management of clinical pharmacology and regulatory engagements.
• Collaborate with Certara team members and clients to develop fit-for-purpose clinical pharmacology strategies.
• Innovate clinical pharmacology approaches and assemble teams for program execution.
• Utilize quantitative modeling and simulation tools to inform clinical trial designs.
• Represent clients in meetings with global health authorities as a subject matter expert.
• Author and contribute to clinical pharmacology documents and reports.
• Interpret DMPK data to support clinical pharmacology study design.
• Mentor and develop junior staff for broader roles.
• Integrate NCA and pharmacometric results to support decision-making.
• Collaborate with peers across disciplines in drug development.
• Co-author peer-reviewed publications and stay updated on clinical pharmacology developments.
• Engage in business development initiatives and identify project opportunities.

Requirements

• Recognized practitioner in clinical pharmacology with experience in clinical development plans.
• PhD or PharmD in pharmacology, pharmacokinetics, or related field; MS in Pharmaceutical Science with relevant experience.
• 15+ years in clinical pharmacology within the pharmaceutical industry or government.
• Experience with small and biologic molecule therapeutics.
• Proven track record in cross-functional drug development teams.
• Strong understanding of CMC, pharm/tox, and biostatistics in drug development.
• Experience in building and leading successful teams.

Skills & Abilities

• Advanced understanding of clinical pharmacology.
• Strong initiative and ability to coordinate multiple projects.
• Excellent client and alliance management skills.
• Ability to mentor junior scientists in clinical pharmacology.
• Proficient in MS Office applications.

Certara is committed to merit-based employment decisions, treating all applicants and employees fairly, without regard to personal characteristics protected by law.