Associate Director, Clinical Pharmacology (BB-AF9E6)
Found in: Talent CA
About Certara Strategic Consulting
Certara Strategic Consulting is the largest pharmacometric organization in the world and assures
that various career pathways are offered to match the ambition and personal interests of our
employees! We are a division of Certara and deliver value by integrating advanced simulation
approaches into the most crucial drug development deliverables to inform internal decision-making
and strengthen global regulatory submissions. Leveraging our experience working on
thousands of key drug development projects on behalf of hundreds of biopharma companies, we
bring a track record of success and a broad range of expertise to each assignment.
As the Associate Director, Clinical Pharmacology, you will support the design, execution, and
management of high quality clinical pharmacology, DMPK, and pharmacometrics studies. This
position plays a pivotal role in assisting our Directors and Sr. Directors as they provide strategic
clinical pharmacology guidance on drug development. Our team includes thought leaders who are
among the most well respected in the growing industry of complex biologic and immunotherapy
platforms! If working alongside smart and driven colleagues sounds exciting to you, we want you on
· Supports client projects through early translational to late development for clinical
pharmacology and quantitative analyses.
· Collaborates with internal and client teams on regulatory, clinical development, clinical
pharmacology, pharmacometric and another drug development issues.
· Assist Project Leaders in writing and compiling reports and other documents summarizing
advice both internally and for clients.
· Perform non-compartmental analyses (NCA), creation of tables, figures and listings (TFL),
authoring of pharmacokinetic (PK) sections in Clinical Study Report, Regulatory Modules, PK
· Conduct data exploration and preliminary PK and PK/PD modeling in support of drug
· Work collaboratively with Project Leader and clients to ensure an adequate clinical
pharmacology package and study design; IND/First in human enabling packages, back
translation of Clinical PK/ADME data and PK-PD relationships.
· Exploring/contribution in insourcing and outsourcing certain aspects of pharmacometric
work, including data management and routine pharmacometric analysis.
· Co/authoring peer-reviewed manuscripts and publications.
Skills & Abilities
· PhD or PharmD or MD degree with specialization in pharmacology or pharmacokinetics, or in
a related scientific discipline.
· 3-6 years of experience, in small or large drug development companies
· Knowledge of translational and clinical pharmacology plans and preparation of regulatory
submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs).
· Experienced in design of clinical pharmacology components of clinical development plans
and optimal application of pharmacometric approaches to support decision making.
· Understanding and/or application of a broad range of clinical pharmacology and quantitative
tools including but not limited to WinNonLin, Phoenix, NONMEM, S-Plus/R and other PK/PD
· Excellent written, verbal and inter-personal communications skills.
· Must be able to work well with a team in a multidisciplinary environment.
Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.
The well-being of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:
· Financial competitive pay, incentives, retirement plans, income security programs
· Health and Wellness comprehensive benefit package, wellness programs, healthy lifestyle
· Work/Life unlimited paid time off and an employee assistance program
· Growth & Development performance driven environment
· Community Impact volunteering opportunities, matching gifts, charitable contributions
Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race,
religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental
disability, national origin, veteran status or any other basis covered by appropriate law. All
employment is decided on the basis of qualifications, merit, and business need.
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