Position Purpose:

• Responsible for designing and implementing a Clinical Pharmacology plan that conforms to appropriate regulatory guidelines such that rational development and registration of drug candidates can be 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, clinical phase oversight, synopsis preparation and reporting).
• Leads 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 (PK), pharmacodynamics (PD), 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 PK-PD analyses with respect to their impact on development and clinical use of drugs.
• In collaboration with global Business Unit, evaluates PK (and/or PD) and safety results among ethnic groups to contribute to the faster submission and authorization in China utilizing global study results.
• Provides clinical pharmacology support and leadership in the preparation and defense of regulatory submissions.

Organizational Relationships:

• Solid line report within the line organization of Development China.
• Collaborates closely with project team members, particularly with other triad colleagues from Clinical Development, Statistics and Pharmacometricians.
• Provides matrix leadership to a wider Clinical Pharmacology team (e.g. from Global Clinical Pharmacology including US/EU Clinical Pharmacology Leads, Pharmacometrics, Clinical Assay Group), particularly for larger projects.
• Other important partnerships can include Development Operations, Pharmacokinetics, Dynamics and Metabolism (PDM), Drug Safety R&D, Pharmaceutical Sciences, Global Medical Affairs, Market Access and Commercial Development.

Resources Managed (budget and FTEs):

• Responsible for designing cost efficient studies and clinical pharmacology programs.

Primary Duties:

• Clinical Pharmacology representative on clinical sub-team and development team as appropriate.
• Responsible for providing the clinical pharmacology components of the clinical development plan and provides clinical pharmacology expertise to the project team with supervision.
• Has a cursory understanding of the overall clinical development plan and works closely with the clinical sub-team and development team to continually update and refine the plan.
• With Clinical Lead, assures that assigned clinical pharmacology studies fulfill their role in the overall development plan.
• Plans, designs and oversees clinical pharmacology studies as required with operational assistance from DC Development Operations.  Accountable and responsible for assigned synopsis and study report content with supervision.
• 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 with supervision.  Assists with internal and external dissemination of results to Development Team, Investigators etc.
• Is a coach and mentor for the clinical study team for the specifics of clinical pharmacology protocols in which it is being conducted.
• Accountable for non-compartmental analysis of PK data and for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc.  Using tools such as NONMEM and R. Directs the planning of all relevant PK-PD analyses.
• Responsible for use of quantitative methods to integrate knowledge of PK, PD, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with Pharmacometrics and Statistics with supervision.
• Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, advice for concomitant administration with food, special population dosing, development of novel formulations, biosimilars and generics etc.) to the clinical sub-team and development team and in regulatory documentation such as labeling with supervision.
• Leads clinical pharmacology contributions to all regulatory documents including Investigator’s

Brochures, CTA and NDA dossier with supervision.  Leads the resolution of clinical pharmacology queries from drug regulatory agencies and takes a lead role in writing and reviewing responses to regulatory queries with supervision.

• Stays abreast of literature, government guidelines, and internal guidance on clinical trial conduct, including internal SOPs, and regulations for specific projects to which assigned in order to be a team resource of clinical pharmacology knowledge in terms of both medical background and clinical trial design.
• Ensures that appropriate subject matter expertise is provided to address regulatory agency queries and interactions with supervision.
• Contributes to regulatory strategy and is prepared to provide regulatory defense of the proposed label with supervision.
• May represent group on company initiative sub-teams.
• May participate in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management.
• Able to present quality scientific work at external meetings and publish the scientific work.  With line management endorsement, manage and initiate external collaborations with world leading clinical pharmacology experts to develop new methodologies.

Qualifications and Attributes:

• Educational:  Pharm. D., Ph.D., or equivalent training or experience in pharmacokinetics, pharmacometrics, clinical pharmacology or related discipline.
• Considerable organizational awareness (inter-relationship of departments, business priorities, etc.)
• At least 2 years of industrial or relevant experience in clinical pharmacology area.

Technical Competencies

• Clinical pharmacology: demonstrates cursory 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 with supervision.
   

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.