Director, Clinical Pharmacology

Role Details

About Certara

Certara is a growing company that provides a dynamic 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.

As the Director, Clinical Pharmacology, you will lead the design, execution, and management of high-quality clinical pharmacology, DMPK, and pharmacometrics studies. This position plays a pivotal role in assisting our Sr. Directors as they provide strategic clinical pharmacology guidance on drug development.

• 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 analysis plans

• Conduct data exploration and preliminary PK and PK/PD modeling in support of drug development decisions

• 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.

• PhD, or PharmD or MD degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline.

• 5+ years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.

• Solid experience in 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 analysis software.

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

Requisition ID: 2023-1489

External Company URL: www.certera.com

Telecommuting: Yes

Overview:

About Certara

Certara is a growing company that provides a dynamic 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.

As the Director, Clinical Pharmacology, you will lead the design, execution, and management of high-quality clinical pharmacology, DMPK, and pharmacometrics studies. This position plays a pivotal role in assisting our Sr. Directors as they provide strategic clinical pharmacology guidance on drug development.

Responsibilities:

• 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 analysis plans

• Conduct data exploration and preliminary PK and PK/PD modeling in support of drug development decisions

• 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.

Qualifications:

• PhD, or PharmD or MD degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline.

• 5+ years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments.

• Solid experience in 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 analysis software.

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

Certara provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.