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Manager, Clinical Pharmacology

Employer
Pfizer
Location
Cambridge, MA
Start date
Sep 12, 2022

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Job Details

ROLE SUMMARY

Clinical Pharmacology Leads at Pfizer are key members of multidisciplinary drug development project teams who provide subject matter expertise in quantitative pharmacology and are uniquely positioned to work at a technical level while having the opportunity to influence drug development strategy within the organization. Working closely with colleagues across research and development, Clinical Pharmacology Leads apply their technical expertise to analyze, develop, validate, and implement quantitative models to inform key drug development decisions. They are also responsible for design, conduct, oversight and reporting of clinical pharmacology components of clinical programs and studies.

We are seeking to hire a Manager, Clinical Pharmacology Lead to join the Clinical Pharmacology team within the Early Clinical Development Clinical Pharmacology group, supporting our Research Units in Cambridge, MA. With some guidance from senior leads, the individual will be responsible for developing and implementing the Clinical Pharmacology Plan and Modeling-Informed Drug Development strategies for early stage drug development programs, using state-of-the-art quantitative methodologies to integrate knowledge of biology, pharmacology, pharmacokinetics (PK), pharmacodynamics (PD) and disease-progression.

RESPONSIBILITIES

  • Help develop clinical pharmacology plan for early stage drug development programs, including both small and large molecules with some guidance from senior leads.

  • Act as clinical pharmacology subject matter expert on multidisciplinary teams working closely with clinicians, biostatisticians, precision medicine and clinical operations colleagues to design, conduct and report clinical trials from first-in-human to proof-of-concept; responsible for clinical pharmacology components including PK, PK/PD, food effect (oral compound), drug-drug interaction, QTc, and immunogenicity (biologics).

  • Collaborate with preclinical scientists and analyze translational models developed from preclinical data to ensure adequate confidence in prediction of human PK and efficacious dose projections.

  • Provide scientific justification for optimal human starting dose and dose escalation schemes for first-in-human protocols based on all available preclinical information including toxicology, efficacy models, physicochemical and biochemical characterization.

  • Work closely with clinical assay specialists to ensure that appropriate and validated bioanalytical assays are available on time for measuring drug concentration and anti-drug antibodies (for biologics) for clinical studies.

  • Conduct PK data analysis and develop computational models from PK/PD, safety and efficacy data collected in early stage clinical trials to support key program decision-making.

  • Present clinical pharmacology results to internal and external stakeholders.

  • Author clinical pharmacology components of clinical documents including protocols, investigator brochures, clinical development plans, and study reports; author scientific publications.

  • Align with global clinical pharmacology groups at Pfizer to maintain consistency with best practices and ensure the state-of-the-art quantitative approaches are being applied to inform key drug development decisions.

BASIC QUALIFICATIONS

  • Advanced degree (Ph.D., Pharm.D.) or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, Engineering, Systems Biology or other related disciplines.

  • Proficiency in mathematical modeling and programming as demonstrated by hands-on experience in computational tools (e.g. R, NONMEM)

  • Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.

  • Excellent verbal and written communication skills.

  • Self-directed and highly-motivated researcher, with willingness to learning new tools and approaches.

PREFERRED QUALIFICATIONS

  • Prior industry experience in clinical pharmacology with expertise in PK/PD modeling.

  • 2-4 years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics.

OTHER JOB DETAILS

  • Eligible for Relocation Package (Cambridge, MA location only)

  • Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Medical

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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