Associate Director Clin Pharm Lead
Company: Pfizer
Location: Somerville
Posted on: January 12, 2021
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Job Description:
ROLE SUMMARY:Our Clinical Pharmacology Leads have key roles to
play in influencing the discovery and development of drugs. It is
exciting, critical work and you could be part of it. Pfizer is a
leader in model informed drug discovery and development (MIDD), and
we are expanding in influence and impact. We have an open position
as Clinical Pharmacology Lead supporting our Research Units in
Cambridge, MA. The ideal candidate embraces MIDD - constructs,
validates, and utilizes disease, placebo, exposure-response, and
mechanistic PKPD models to evaluate risk/benefit and facilitate
drug development decisions, in close collaboration with other
R&D partners. Clinical Pharmacology Leads are also responsible
for planning and direction of clinical pharmacology components of
clinical programs (including clinical development plan/life cycle
plan) and studies (including protocol preparation; clinical phase
oversight, and reporting).ROLE RESPONSIBILITIES: Act as Clinical
Pharmacology representative on Clinical Sub Team and Development
Team as appropriate.Participate in implementing MIDD using
quantitative approaches to address complex questions arising during
drug development spanning from target validation to analysis and
interpretation of Phase II results.Responsible for providing the
clinical pharmacology components of Clinical Plans and provides
clinical pharmacology expertise to the project team including plan,
design and oversee clinical pharmacology studies with operational
assistance from operations colleagues.Fully knowledgeable about the
clinical pharmacology profile of allocated drugs on which studies
are being conducted or which are called for in the
protocol.Coordinates with medical writers (and other team members)
in the data review, analysis and reporting of the CP study.
Responsible, in conjunction with medical writer, for overall
content and accuracy of study report before forwarding for final
sign-off.Accountable and responsible for non-compartmental analysis
of PK data and accountable and --- as appropriate --- responsible
for ensuring appropriate PK-PD analysis including population PK,
PK-PD modeling and simulation, meta-analysis etc.Directs the
planning of all relevant PK-PD analyses. Responsible for use of
innovative analytical methods to integrate knowledge of
pharmacokinetics, pharmacodynamics, patient characteristics and
disease states to optimize doses, dosage regimens and study designs
throughout clinical drug development in collaboration with
pharmacometrics and statistics (as relevant).Provides
recommendations for clinical doses and dosing algorithms (including
drug interaction advice, food effects, special group dosing etc) to
the clinical and Development teams and in regulatory
documentation.Leads clinical pharmacology contributions to all
regulatory documents including IND, CTA, Investigator Brochures,
EOP2 meetings. Leads the resolution of clinical pharmacology
queries from drug regulatory agencies, takes a lead role in writing
and reviewing responses to regulatory queries.Provides Clinical
Pharmacology expertise to Drug Discovery. During the pre-clinical
stages of drug development works with Research to ensure
quantitative mechanistic understanding and preclinical PK-PD
knowledge exist to underwrite human administration.Accountable for
ensuring that there are valid methods for measuring drug
concentration (and any biochemical biomarkers) in the clinic.May
participate in multidisciplinary teams in assessing potential
in-licensing opportunities, as requested by line
management.QUALIFICATIONS: 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.---Strong
quantitative skills and expertise (e.g. experience in PKPD
modeling/systems pharmacology, literature meta-analyses, population
modeling, and clinical trial simulations).PhD in Clinical
Pharmacology, Pharmacokinetics, Pharmacometrics, Engineering or
other suitable post-graduate qualification.> 4 years of industry
experience in clinical pharmacology and/or clinical PK/PD and/or
Pharmacometrics.Excellent written and verbal communication
skills.Demonstrated presentation skillsOther Job Details:Eligible
for Relocation Package: YESEligible for Employee Referral Bonus:
YESLI-PFESunshine ActPfizer 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 EligibilityPfizer 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.MedicalFull time
Keywords: Pfizer, Somerville , Associate Director Clin Pharm Lead, Executive , Somerville, Massachusetts
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