[Hiring] Senior Director, Clinical Pharmacology @Certara

Role Description

Leads multidisciplinary teams in delivering on the design, execution, strategy and management of various development, clinical pharmacology and regulatory engagements, from early translation to late development.

• Works 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/BLA.
• Develops 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 program.
• Leverage quantitative modelling and simulation tools to answer development questions and to design and inform clinical trial designs and clinical development strategy.
• Represent clients at meetings and advisory hearings with global health authorities as a subject matter expert.
• Lead others in authoring and contributes to documents summarizing clinical pharmacology data and program strategy including CSRs, reports, and health authority documents.
• Interpret DMPK data with a focus on translation and applies information to support clinical pharmacology study design and strategy.
• Contributes to training and mentoring for staff, develops junior staff for broader functional roles either as a direct manager or on project teams.
• Interprets and integrates NCA and pharmacometric results to support decision making including evolving clinical pharmacology strategy and development strategy.
• Actively collaborates with multidisciplinary peers (e.g., biostats, clinical, pharm/tox, CMC) and has a working understanding of the multidisciplinary requirements of drug development.
• Co/authoring peer-reviewed manuscripts and publications.
• Reviews publications to keep apprised of new clinical pharmacology and therapeutic area developments.
• Involvement in program committees, workshops, and other professional organization meetings/sessions.
• Participate in company initiatives.
• Leads in business development initiatives and independently generates business development leads and represents respective line function and broader Certara capabilities on client scoping calls.
• Identifies project opportunities, structures WO and budget, formulates teams and identifies needs and resources necessary to execute projects. Authors work orders when necessary.

Qualifications

• Must 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 success.
• PhD 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 pharmacology.
• 12+ years of experience including clinical pharmacology experience in the pharmaceutical industry or government.
• Previous consulting experience or thought leader in clinical pharmacology or drug development space.
• Broad therapeutic area and small and/or biologic molecule therapeutics experience.
• Experienced in designing and executing clinical pharmacology studies.
• Experience 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 drug development team.
• Understanding of the CMC, pharm/tox, biostats, clinical and other multidisciplinary requirements of drug development.
• Experience building and leading successful teams (within and/or across functions).

Skills & Abilities

• Advanced understanding of the clinical pharmacology discipline.
• Strong initiative, self-motivation and demonstrated ability of coordinating multiple projects and/or tasks.
• Possess a strong focus on influencing at high levels, innovation, and customer centricity.
• Strong client and alliance management skills.
• Ability to mentor and develop junior PK scientist on clinical pharmacology science and strategy either as a direct mentor or on project teams.
• Ability to work across functions to implement company initiatives.
• Excellent written, verbal and inter-personal communications skills.
• Must be able to work well and lead a team in a multidisciplinary environment.
• MS Office products including Outlook, PowerPoint, Excel, and Word.