BoulderRecruiter Since 2001
the smart solution for Boulder jobs

Clinical Director

Company: Pfizer
Location: Boulder
Posted on: June 8, 2021

Job Description:

ROLE SUMMARY

At Pfizer, we are driven by science, discovering breakthroughs that change patients lives. As a leader in Model-Informed Drug Development (MIDD), Pfizer Clinical Pharmacology as a discipline plays key roles in developing innovative medicines to address unmet medical needs. Our Clinical Pharmacology Leads 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. Clinical Pharmacology Leads are also responsible for design, conduct, oversight, and reporting of clinical pharmacology components of clinical programs and studies.

Our Oncology Clinical Pharmacology group within Early Clinical Development Clinical Pharmacology has an exciting opening for a Senior Director position at the Boulder, CO location. Reporting to the Head of Early Oncology Clinical Pharmacology, this position will supervise a team of Clinical Pharmacology Leads to support part of the early oncology portfolio, provide strategic insights to enable accelerated and robust decision-making, and lead internal and external collaborations to advance the science for early oncology development. The position will also be responsible for developing and implementing the Clinical Pharmacology Plan and MIDD strategy for early oncology programs. The ideal candidate will have prior industry experience in clinical pharmacology, strong expertise in quantitative modeling, and experience in managing, mentoring and coaching.

ROLE RESPONSIBILITIES

  • Provides Clinical Pharmacology leadership and technical oversight for part of the early oncology portfolio.

  • Collaborates with peers in other functional groups to achieve business goals.

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

  • Leads and manages a team of Clinical Pharmacology Leads.

  • Develops clinical pharmacology plan for early oncology drug development programs, including both small and large molecules.

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

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

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

  • Works 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.

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

  • Presents clinical pharmacology results to internal and external stakeholders.

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

BASIC QUALIFICATIONS

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

  • At least 12 years of industry or equivalent experience in clinical pharmacology and/or clinical PK/PD and/or pharmacometrics.

  • Demonstrated experience in managing and coaching colleagues.

  • Proficiency in mathematical modeling and programming as demonstrated by hand-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.

  • Prior drug development experience in the oncology therapeutic area.

  • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

OTHER JOB DETAILS

  • Eligible for Employee Referral Bonus

  • Eligible for Relocation Package

#LI-PFE

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 providers 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#LI-PFE

Keywords: Pfizer, Boulder , Clinical Director, Other , Boulder, Colorado

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Colorado jobs by following @recnetCO on Twitter!

Boulder RSS job feeds