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6 days old

Associate Director/Director Clinical Pharmacology

Kelly Services
South Plainfield, NJ 07080
The Associate Director/Director, Clinical Pharmacology develops and executes Clinical Pharmacology and Pharmacometrics strategies across the portfolio; participates in the design of clinical and relevant non-clinical studies; and interprets, presents and reports clinical and non-clinical study results.

The incumbent works cross-functionally with internal departments and external resources as part of drug development teams.

The Associate Director, Clinical Pharmacology supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.


**Job Description:**


**_Primary duties/responsibilities:_**


+ Acts as the lead clinical pharmacologist for multiple clinical stage programs.

+ Develops an overarching clinical pharmacology strategy from IND to NDA (or BLA) to support regulatory submissions.

+ Predicts human Pharmacokinetic (PK) parameters and exposure profiles using in vitro and animal PK data.

+ Estimates the Maximum Recommended Starting Dose (MRSD) based on toxicology study results for the First In Human (FIH) clinical trials.

+ Implements optimal dose-finding strategies to ensure safe and effective advancement of clinical programs.

+ Designs and oversees clinical pharmacology studies to evaluate PK in special populations. This includes, but may not be limited to, pediatric and geriatric patients or those with renal and hepatic impairments as examples.

+ Designs clinical drug-drug interaction and food effect studies following regulatory guidance.

+ Drafts Investigators Brochures (IBs), eCTD modules, and clinical study protocols in close partnership with clinical operations, medical, regulatory, biostatistics, and medical writing professionals.

+ Performs PK analyses in non-compartmental model for the drug and/or metabolites.

+ Performs population PK/PD analyses and integrates this knowledge into the overall clinical development strategy(ies).

+ Evaluates and selects Contract Research Organizations (CROs) and manages/actively oversees outsourced PK, PK/PD, and exposure-response analyses.


**KNOWLEDGE/SKILLS/ABILITIES REQUIRED**


_* Minimum level of education and years of relevant work experience._


+ PhD in a relevant scientific discipline OR a PharmD and a minimum of 7 years of progressively responsible experience in a pharmaceutical, biotechnology or related environment OR equivalent combination of experience and education.


**_* Special knowledge or skills needed and/or licenses or certificates required._**


+ Strong experience with common PK/PD modeling software packages (such as Phoenix WinNonlin).

+ Highly proficient in performing NCA PK analysis.

+ Demonstrated expertise in developing and executing drug metabolism and pharmacokinetics studies.

+ Demonstrated understanding or, and experience applying, clinical pharmacology concepts.

+ Demonstrate understanding of formulation and toxicology.

+ Familiar with regulatory guidance especially for drug interaction studies.

+ Experience managing multiple projects with competing priorities.

+ Demonstrated experience in writing study reports and regulatory documents.

+ Ability to influence without direct authority.

+ Excellent verbal and written communication and skills.

+ Ability to work independently and collaboratively. as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

+ Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

+ Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

+ Excellent management and interpersonal skills.


**_*Special knowledge or skills and/or licenses or certificates preferred._**


+ Experiences in oncology and CNS therapeutic areas.

+ Experiences in multiple modalities (small molecules, biologics, and cell or gene therapies).

+ Experience with common PBPK modeling software (such as GastroPlus).


**APPLY NOW!**


**For immediate consideration, please send your resume in a WORD document to gaut985@kellyservices.com**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-13 Expires: 2021-10-14

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Associate Director/Director Clinical Pharmacology

Kelly Services
South Plainfield, NJ 07080

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