1+ months

Clinical Medical Lead China/

Pfizer
Beijing
**MAIN REPONSIBILITIES / DUTIES**



+ This role works towards developing innovative ideas and approaches to implement the strategies and tactics of the Upjohn GCR RDM organization for development of complex molecules for non-communicable diseases (NCD)

+ Serves as a single point of accountability to GCR for clinical deliverables involving complex NCD products and for Upjohn products within Clinical Affairs

+ Focused on the planning, design, execution, monitoring, delivery, and reporting of multiple clinical studies for the Clinical Plan of each NCD drug.

+ Ensures appropriate medical and scientific expertise is brought to all aspects of clinical trials from initial design to final interpretation and reporting.

+ Manages multiple third-party vendors, clinical study sites and CROs

+ Ensures clinical trial forecasting scenarios are aligned and budgeted as well as transacted according to Upjohn processes. Plans and ensures appropriate clinical resources are assigned to assets for each clinical protocol and program.

+ Maintains good knowledge of multiple disease area(s) to provide context for functional and technical excellence; aligns and collaborates with the relevant Upjohn Medical Affairs Disease Area Leads.

+ Point of accountability for GCR for design, execution, monitoring, delivery and reporting of one or more clinical studies (or elements of those studies).

+ Provides medical and scientific expertise to the clinical trial strategy and development process, including acquisition of knowledge of competitor products.

+ May act as primary contact with regulatory authorities, external investigators and internal study team for questions relating to the scientific/medical aspects of the protocol. Presents to internal and external advisory committees (e.g. TRC, advisory boards).

+ Assists in the preparation of the clinical content of regulatory submissions/documents

+ Designs/writes clinical trial outlines, in collaboration with third party vendors, internal contributors (e.g. statisticians, OR specialists, clinical pharmacologists, clinical project managers, market access colleagues, commercial development colleagues), internal experts (e.g. clinical disease area expert), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.

+ Provides medical input to protocol/study team for monitoring guidelines, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team)

+ Conducts medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.



+ Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.

+ Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions in regulatory based results database such as CT.Gov.

+ Assists in discussions with regulators and with the resolution of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries

+ Plans resources required within Clinical Affairs to accomplish teh clinical objectives in a timely and resource efficient fashion



**INTERACTIONS**



This position will report to the New Product Development Lead

Expected departmetal interactions for the NPD lead



+ Across the Medical LT

+ Business Development Lead

+ Innovation Lead

+ Regulatory Lead and team for GCR

+ Global portfolio team

+ Global R&D team

+ Marketing Lead and team



**REQUIRED SKILL SET**



+ Technical



+ Therapeutic area knowledge: familiar with the disease knowledge and clinical practice.

+ Familiar with the pharmaceutical industry and healthcare environment in China

+ Knowledge of clinical research and regulatory are preferred.

+ Language: excellent in oral and written English.

+ Innovative and pioneering spirit

+ Strategic and logical thinking.

+ Strong Leadership capabilities, such as decision marking, problem solving, plan and implementation.

+ Excellent communication skill and strong influencing and negotiation skills.

+ Leads change, Shape the future.



+ Certifications



N/A



+ Education



+ Major in Clinical medicine. Medical Master or doctoral degree in medical is preferred.

+ A qualification in research is a plus.



+ Experience



+ Strong medical background and at least 5 years clinical practice experience.

+ At least 8 years pharmaceutical industry experience.

+ At least 6 years Medical Affairs experience.

+ Clinical Research experience is preferred

+ Medical development is preferred but not a must



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



Medical

Categories

Posted: 2020-03-16 Expires: 2020-06-17

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Clinical Medical Lead China/

Pfizer
Beijing

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