Senior Director, Clinical Pharmacology

Certara•UNAVAILABLE, UNAVAILABLE

About The Position

The Senior Director, Clinical Pharmacology leads multidisciplinary teams in the design, execution, strategy, and management of clinical development, clinical pharmacology, and regulatory engagements, from early translation through late development. The role works with Certara colleagues and clients to develop fit-for-purpose clinical pharmacology and quantitative program strategies that support development and regulatory decisions from IND/first-in-human through NDA/BLA. The position applies quantitative modeling and simulation to development questions, clinical trial design, and clinical development strategy; interprets DMPK, NCA, and pharmacometric results; and contributes to clinical pharmacology documents and regulatory submissions. It also represents clients before global health authorities, mentors and develops staff, contributes to publications and professional activities, and leads business development by identifying opportunities, structuring work orders and budgets, and assembling project teams.

Requirements

Recognized applied development practitioner with experience designing and stewarding clinical pharmacology components of clinical development plans and applying pharmacometrics approaches to support decision-making and regulatory success.
PhD, PharmD, or equivalent degree with a specialization in pharmacology or pharmacokinetics, or a related scientific discipline; alternatively, an MS in Pharmaceutical Science with job-related experience in drug development and clinical pharmacology.
At least 12 years of experience, including clinical pharmacology experience in the pharmaceutical industry or government.
Previous consulting experience or recognition as a thought leader in clinical pharmacology or drug development.
Broad therapeutic-area experience and experience with small-molecule and/or biologic therapeutics.
Experience designing and executing clinical pharmacology studies.
Experience in translational and clinical pharmacology at different stages of development and in regulatory submissions, such as INDs, NDAs, and BLAs.
Experience providing input on clinical pharmacology plans and preparing regulatory submissions, such as INDs, NDAs, BLAs, and/or significant sNDAs/sBLAs.
Demonstrated functional-role experience on cross-functional drug development teams.
Understanding of CMC, pharm/tox, biostatistics, clinical, and other multidisciplinary drug development requirements.
Experience building and leading successful teams within and/or across functions.
Advanced understanding of the clinical pharmacology discipline.
Strong initiative, self-motivation, and demonstrated ability to coordinate multiple projects and/or tasks.
Ability to influence at high levels, innovate, and maintain customer centricity.
Strong client and alliance management skills.
Ability to mentor and develop junior PK scientists in clinical pharmacology science and strategy, as a direct mentor or on project teams.
Excellent written, verbal, and interpersonal communication skills.
Ability to work well and lead a team in a multidisciplinary environment.
Proficiency with MS Office products, including Outlook, PowerPoint, Excel, and Word.

Responsibilities

Collaborate with and lead Certara team members and clients to develop clinical pharmacology and quantitative program strategies supporting development and regulatory decisions from IND/first-in-human through NDA/BLA.
Develop innovative clinical pharmacology approaches, processes, and drug development strategies, and assemble multidisciplinary teams to execute clinical pharmacology programs.
Use quantitative modeling and simulation tools to answer development questions 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 and contribute to authoring documents summarizing clinical pharmacology data and program strategy, including clinical study reports, reports, and health authority documents.
Interpret DMPK data, focusing on translation, and apply the information to clinical pharmacology study design and strategy.
Train and mentor staff and develop junior staff for broader functional roles, as a direct manager or through project teams.
Interpret and integrate NCA and pharmacometric results to support decision-making and evolving clinical pharmacology and development strategies.
Collaborate with multidisciplinary peers, including biostatistics, clinical, pharm/tox, and CMC colleagues, and apply an understanding of multidisciplinary drug development requirements.
Co-author or author peer-reviewed manuscripts and publications.
Review publications to stay current with clinical pharmacology and therapeutic-area developments.
Participate in program committees, workshops, and other professional organization meetings and sessions.
Participate in company initiatives and work across functions to implement them.
Lead business development initiatives, generate business development leads, and represent the line function and broader Certara capabilities on client scoping calls.
Identify project opportunities, structure work orders and budgets, formulate teams, identify execution needs and resources, and author work orders when necessary.