There are open positions at China Development, Pfizer, (Shanghai or Beijing)
China
Clinical Pharmacology Lead (Director/Manager)
Responsibilities:
* Responsible for designing and implementing a Clinical Pharmacology
plan that conforms to appropriate regulatory guidelines such that rational
development and registration of drug candidates is rapidly achieved in China.
* Serves as the Clinical Pharmacology representative on drug
development and clinical sub-teams and provides clinical pharmacology expertise
and leadership to projects.
* Plans and directs clinical pharmacology components of clinical
programs (including clinical development plan) and studies (including design,
synopsis preparation and reporting).
* Works with multifunctional study team to design, deliver and report
the assigned clinical pharmacology studies and has overall scientific
accountability for the designated studies.
* Responsible (with Clinicians and Statisticians) for ensuring
appropriate dose-finding strategies during clinical drug development that will
ensure optimal doses and dosage regimens in patients.
* Accountable for the development and implementation of a clinical
modeling and simulation plan based on agreed upon best practices (i.e.
model-based drug development) in collaboration with Pharmacometrics.
* Responsible for use of quantitative methods to integrate knowledge of
pharmacokinetics, pharmacodynamics, patient characteristics and disease states
to optimize doses, dosage regimens and study designs throughout clinical drug
development.
* Responsible for appropriate summarization and interpretation of
results of pharmacokinetic/ pharmacodynamic (PK-PD)analyses with respect to
their impact on development and clinical use of drugs.
* Plans, designs and oversees clinical pharmacology studies as required
throughout post-POC drug development with operational assistance from
Development Operations. Accountable and responsible for assigned synopsis and
study report content.
* With study team, tracks emerging clinical pharmacology profile of the
drug, keeps line management informed of changes in the profile as they occur in
the assigned studies. Must be fully knowledgeable about the clinical
pharmacology profile of allocated drugs for which studies are being conducted
or which are called for in the protocol (e.g. interacting drug).
* Coordinates with medical writers (and other team members) in the data
review, analysis and reporting of clinical pharmacology studies. Is
responsible, in conjunction with medical writer, for overall content and
accuracy of study report before forwarding for final sign-off. Assists with
internal and external dissemination of results to Development Team,
Investigators etc.
* In cooperation with Global (ex China) Clinical Pharmacology and
Development Teams, evaluate and compare PK (and/or PD) and safety results among
ethnicity to contribute to the faster submission and authorization utilizing
Global study results.
* Provides clinical pharmacology support and leadership in the
preparation and defense of regulatory submissions.
* May supervise, coach and develop less experienced Clinical
Pharmacology Leads.
Qualifications and Attributes:
* Education: Pharm. D., Ph.D., or equivalent training or experience in
pharmacokinetics, pharmacometrics, clinical pharmacology, engineering or
related discipline.
* Considerable organizational awareness (inter-relationship of business
units, departments, business priorities, etc.)
* Effective supervisory experience.
Technical Competencies:
* Clinical pharmacology: demonstrates thorough understanding of the
following: 1) principles of PK, PK-PD and pharmacology relevant to drug
candidates; 2) other relevant scientific disciplines, including drug
metabolism, drug transport, formulation sciences, biopharmaceutics,
pathophysiology and therapeutics; and 3) quantitative modeling and simulation
principles
* Communication Skills: Demonstrates ability to effectively present
PK/PD data, Clinical Pharmacology Development Plans and strategies to various
audiences in both verbal and written form (English and Mandarin); demonstrate
ability to write PK/PD results, interpretations (including impact) and
conclusions for Clinical Study Reports and regulatory documents that are clear
and concise.
* Regulatory Knowledge: Understands and is able to apply appropriate
China FDA, US FDA, EMA and ICH guidelines in the design of clinical development
plans and studies.
To apply please visit the careers pages on
http://www.pfizer.com and enter the following job opening
number:
Director, Clinical Pharmacology Lead: Job ID 1023611
Manager, Clinical Pharmacology Lead: Job ID 1023612