Associate Director Clin Pharm Lead
Company: Black Enterprise Magazine
Posted on: February 20, 2021
**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).
+ 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
+ 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 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
+ 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
+ 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.
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 skills
**Other Job Details:**
+ Eligible for Relocation Package: YES
+ Eligible for Employee Referral Bonus: YES
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.
Keywords: Black Enterprise Magazine, Cambridge , Associate Director Clin Pharm Lead, Executive , Cambridge, Massachusetts
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