Clinical Pharmacology Lead
Posted on: April 4, 2021
United States - Massachusetts - Cambridge 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 Clinical
Pharmacology Lead to join the Clinical Pharmacology team within the
Early Clinical Development, based in Cambridge, MA. The individual
will be responsible for developing and delivering
modeling/simulation and clinical pharmacology strategies for early
development programs using state-of-the-art quantitative
methodologies to integrate knowledge of disease biology,
pharmacology, pharmacokinetics (PK), pharmacodynamics (PD) and
competitors. ROLE AND RESPONSIBILITIES
- Act as Clinical Pharmacology representative on Clinical Sub
Team and Development Team as appropriate.
- Participate in implementing model based drug development 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
- 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
- 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, statistics and QSP (as
- 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
- 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
- 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
- Accountable for ensuring that there are valid methods for
measuring drug concentration (and any biochemical biomarkers) in
- May participate in multidisciplinary teams in assessing
potential in-licensing opportunities, as requested by line
management. BASIC QUALIFICATIONS
- --Advanced degree (Ph.D., Pharm.D., MD) or equivalent
experience in Pharmacokinetics, Pharmacometrics, or other related
- Experience in clinical pharmacology and/or pharmacometrics
and/or translational modeling.
- 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, and multi-site team setting.
- Excellent verbal and written communication skills.
- Self-directed and highly-motivated researcher, with willingness
to learning new tools and approaches. Other Job Details:
- Eligible for Relocation Package: YES
- Eligible for Employee Referral Bonus: YES #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 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. 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 Pfizer careers are like no other.
In our culture of individual ownership, we believe in our ability
to improve future healthcare, and potential to transform millions
of lives. We're looking for new talent to join our global
community, to unearth new innovative therapies that make the world
a healthier place.
Keywords: Pfizer, Cambridge , Clinical Pharmacology Lead, Healthcare , Cambridge, Massachusetts
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