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Pharmacometrician at Advanced Group

Posted in Other 30+ days ago.

Location: Bedminster, New Jersey





Job Description:


OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a Pharmacometrician in Bedminster, New Jersey. The Pharmacometrician role will provide scientific oversight for population pharmacokinetics, pharmacokinetics/pharmacodynamics, and exposure-response analyses to support all clinical programs. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES


  • Implement pharmacokinetics and pharmacology model-based PKPD, population PK, exposure-response (ER) to optimize doses, dosage regimens, and study designs for larger molecules bio-medication with sufficient larger half-life and limited clearance

  • Identify patient and medication-related factors that impact pharmacokinetics, efficacy and safety, and other clinical and regulatory issues for the support of clinical development programs

  • Ensure timely delivery to support key development questions addressing relationships between PK/biomarkers, efficacy, and safety endpoints

  • Verify development and validation of programming code in relevant software for PK, PKPD, ER modeling, and simulation analyses

  • Collaborate with clinical, biostats, commercial, and regulatory to ensure optimal integration of modeling and simulation to address key clinical questions to support advancement of the company in a timely and efficient manner

  • Review and write modeling/simulation analysis plans and reports

  • Provide input for standard operation procedures and best practices in pharmacometrics

  • Participate in cross-functional project teams and provide quantitative input for dose selection and study designs using modeling and simulation

  • Contribute to the summary documents for regulatory submissions

  • Maintain current knowledge of literature and regulatory guidelines relating to pharmacometrics and quantitative clinical pharmacology

  • Author clinical protocols and clinical pharmacology and pharmacokinetic sections of regulatory documents

  • Support protocol development, study reports/regulatory documents, preclinical, clinical/CMC data interpretation, and communication of results to stakeholders


EXPERIENCE

  • Minimum of 5 years of industry experience in practical applications of modeling and simulation in preclinical/clinical pharmacology required

  • Demonstrated expertise within the field of quantitative pharmacology including PK compartment modeling, PKPD modeling, and E-R modeling

  • Experience identifying, developing, and executing strategic quantitative pharmacology activities at the project level

  • Strong knowledge of regulatory, compliance, processes, and standards specific to pharmacometrics/quantitative pharmacology

  • Demonstrated broad clinical development expertise and experience in drug development, with emphasis on pharmacometrics/quantitative pharmacology

  • Relevant regulatory experience (written/oral)

  • Strong technical expertise with pharmacometrics' software (i.e. ICON NONMEM, Phoenix WinNonLin, NLME, etc)

  • Experience with lipid-soluble larger molecules drugs and lipids/lipoprotein therapy desired


EDUCATION
  • Minimum of Ph.D. in Pharmacometrics, Clinical Pharmacokinetics, Clinical Pharmacology, Systems Pharmacology, or relevant degrees in similar medical disciplines (where quantitative pharmacology is emphasized) required

To be a best-fit your strengths must include:

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.

  • Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.

  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.

  • Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.

  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.

  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.


About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.


It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.



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