Posted on: June 8, 2021
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.
Provides Clinical Pharmacology leadership and technical
oversight for part of the early oncology portfolio.
Collaborates with peers in other functional groups to achieve
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
Collaborates with preclinical scientists and analyzes
translational models developed from preclinical data to ensure
adequate confidence in prediction of human PK and efficacious dose
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
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
Authors clinical pharmacology components of clinical documents
including protocols, investigator brochures, clinical development
plans, and study reports; authors scientific publications.
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
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,
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
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
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.
Keywords: Pfizer, Boulder , Clinical Director, Other , Boulder, Colorado
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