[Remote] Director, Clinical Pharmacology

Note: The job is a remote job and is open to candidates in USA. Certara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services. The Director of Clinical Pharmacology will lead multidisciplinary teams in developing clinical pharmacology strategies, leveraging quantitative modeling, and representing clients at advisory meetings with health authorities.ResponsibilitiesWorks collaboratively with and leads Certara team members and clients to develop clinical pharmacology and quantitative program strategies that are fit-for purpose to enable development and regulatory decisions for IND/First in human to NDA/BLADevelops new innovative and impactful clinical pharmacology approaches to processes and drug development strategies and can assemble a multidisciplinary team to execute the components of clinical pharmacology programLeverage quantitative modelling and simulation tools to answer development questions and to design and inform clinical trial designs and clinical development strategyRepresent clients at meetings and advisory hearings with global health authorities as a subject matter expertLead others in authoring and contributes to documents summarizing clinical pharmacology data and program strategy including CSRs, reports, and health authority documentsInterpret DMPK data with a focus on translation and applies information to support clinical pharmacology study design and strategyContributes to training and mentoring for staff, develops junior staff for broader functional roles either as a direct manager or on project teamsInterprets and integrates NCA and pharmacometric results to support decision making including evolving clinical pharmacology strategy and development strategyActively collaborates with multidisciplinary peers (e.g., biostats, clinical, pharm/tox, CMC) and has a working understanding of the multidisciplinary requirements of drug developmentCo/authoring peer-reviewed manuscripts and publicationsReviews publications to keep apprised to keep apprised of new clinical pharmacology and therapeutic area developmentsInvolvement in program committees, workshops, and other professional organization meetings/sessionsParticipate in company initiativesLeads in business development initiatives and independently generates business. development leads and represents respective line function and broader Certara capabilities on client scoping callsIdentifies project opportunities, structures WO and budget, formulates teams and identifies needs and resources necessary to execute projects. Authors work orders when necessarySkillsMust be recognized applied development practitioner, experienced in both design and stewardship of clinical pharmacology components of clinical development plans and optimal application of pharmacometrics approaches to support decision making and regulatory successPhD or PharmD degree or equivalent degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline. MS in Pharmaceutical Science with job related experience in the field of drug development and clinical pharmacology7 - 12+ years of experience including clinical pharmacology experience in the pharmaceutical industry or governmentBroad therapeutic area and small and/or biologic molecule therapeutics experienceExperienced in designing and executing clinical pharmacology studiesExperience with translational and clinical pharmacology work at different stage of development and for regulatory submissions (e.g. INDs, NDAs, and BLAs)Experience in providing input on clinical pharmacology plans and preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs)Demonstrated track record in a functional role on cross functional dug development teamWorking understanding of the CMC, pharm/tox, biostats, clinical and other multidisciplinary requirements of drug developmentExperience building and leading successful teams (within and/or across functions)Advanced understanding of the clinical pharmacology disciplineStrong initiative, self-motivation and demonstrated ability of coordinating multiple projects and/or tasksPossess a strong focus on influencing at high levels, innovation, and customer centricityStrong client and alliance management skillsAbility to mentor and develop junior PK scientist on clinical pharmacology science and strategy either as a direct mentor or on project teamsAbility to work across functions to implement company initiativesExcellent written, verbal and inter-personal communications skillsMust be able to work well and lead a team in a multidisciplinary environmentMS Office products including Outlook, PowerPoint, Excel, and WordCompany OverviewCertara is a pharmaceutical company that accelerates medicines with biosimulation software and technology. It was founded in 2008, and is headquartered in Princeton, New Jersey, USA, with a workforce of 1001-5000 employees. Its website is https://www.certara.com.Company H1B SponsorshipCertara has a track record of offering H1B sponsorships, with 7 in 2025, 10 in 2024, 3 in 2023, 10 in 2022, 5 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.