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Clinical Therapy Area Lead, Sterile Injectables (Sr Dir MD)

Pfizer


Location:
New York, NY
Date:
12/16/2017
2017-12-162018-01-16
Pfizer
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Job Details

**ROLE SUMMARY**



Reporting to the Clinical Affairs Head, the Clinical Therapy Area Lead, Sterile Injectables with be a t ransformational leader who can develop innovative ideas and approaches to implement the strategies and tactics of the Pfizer Essential Health (PEH) business unit Chief Medical Office ( CMO) organization for development of complex generics and sterile injectable products. An experienced drug developer, s/he s erves as a single point of accountability to the PEH business unit for clinical deliverables involving complex generic products. Focused on the planning, design, execution, monitoring, delivery, and reporting of one or more clinical studies for the Clinical Plan of each candidate drug, will ensures appropriate medical and scientific expertise is brought to all aspects of clinical trials from initial design to final interpretation and reporting..







T he Clinical Therapy Area Lead, Sterile Injectables Manages and coaches Clinical Leads and Clinicians in matrixed teams working on clinical Equivalence/BE and other safety and efficacy trials in patients treated with sterile injectables for multiple Disease Areas (esp endocrinology, neuro-psychiatric drugs, oncology, hematology); e nsures clinical trial forecasting scenarios are aligned and budgeted as well as transacted according to Pfizer processes. With the Clinical Affairs Lead, plans and ensures appropriate clinical resources are assigned to assets for each clinical protocol and program. Maintains good knowledge of disease area(s) of responsibility in order to provide context for functional and technical excellence; aligns and collaborates with the relevant PEH Medical Affairs Disease Area Leads; and p erforms clinical trial safety review in role of Physician-Clinician (medical monitor).







This is an exciting opportunity for a "player-coach" to build out a team.







**ROLE RESPONSIBILITIES**



Clinical Development - including but not limited to:







+ Point of accountability for selected sterile injectable products within Clinical Affairs



+ Point of accountability to the Business Unit 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.



+ Works closely with Clinical Pharmacologists and Statisticians to ensure the most efficient clinical protocols are developed through the application of enhanced trial design.



+ 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).



+ Leads or assists in the preparation of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).



+ Designs/writes clinical trial outlines, in collaboration with 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).



+ Collaborates with Clinical Operations on CRO/vendor oversight to ensure medical/technical requirements for data integrity are applied (e.g. lab specifications).



+ Oversees study management staff in selecting geographic footprint of countries, clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost effective manner.



+ Helps establish and oversee Data Monitoring Committees (DMCs), Safety Assessment Committees (SACs) and adjudication committees.



+ 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. Tracks emerging efficacy and safety profile of drugs consistent with Safety Review Plan; responsible for identifying emerging safety trends and raising them forward for further discussion of benefit:risk at RMCs.



+ 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 ensuring regulatory compliance for clinical trials and reporting.



+ 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.



+ Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.



+ Leads or assists in the development of publications, abstracts, presentations.



+ May support technical review of licensing opportunities, including due diligence activities.



+ Ensures technical excellence and functional competency of matrixed teams.







As a Clinical Lead







+ Functions as an individual contributor in their specialty area of expertise.



+ Accountable for design and final recommendations for clinical plans for compounds / indications overseen by their respective Development Team.



+ Accountable for negotiating milestones and ensuring execution and delivery of the clinical plan in line with agreed timelines.



+ Leads the Clinical Team to design, execute and interpret registration and PAC studies.



+ Acquires knowledge of competitor products and clinical plans .



+ Plans resources required both within Clinical Affairs and in conjunction with other relevant lines to accomplish the clinical objectives in a timely and resource-efficient fashion, including consideration of FTEs and operational resourcing.



+ Ensures development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinical lead may delegate these responsibilities to the study clinician identified in the SRP. For all studies, clinical safety review should be performed in consultation with a designated medical monitor if neither clinical lead nor clinician are medically qualified.







As a Physician Clinician







+ Medically qualified clinicians assume the role of physician clinician in oversight of non-medically qualified clinicians. Specific duties that require medical oversight include IB review, protocol review, safety review and clinical study report review. In addition, a physician clinician must be available for medical questions from investigators when required.



+ Consistent with SRP, oversees regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead (as delegated by the clinical lead). The specific components of safety data review are detailed in the Safety Data Review Guide.







General







+ Motivates and engages colleagues to facilitate an understanding of disease and foster team commitment to support an indication and mechanism.



+ Coaches and mentors less experienced clinicians.



+ Maintains and enhances knowledge in relevant disease area and/or technical area and practice guidelines relevant to the regions in which clinical trials are being conducted.



+ Facilitates sharing of information on technical or operational best practices and lessons learned across Clinical Affairs.







Expected travel 20% (international and domestic)



This role can be located at NYHQ, Groton, CT, Collegeville, PA or Cambridge, MA.







**QUALIFICATIONS**







+ MD degree.



+ Postgraduate training/certification /fellowship in a medical specialty. Endocrinology, Neurology, Psychiatry, or Oncology specialties of adult internal medicine preferred.



+ Required: minimum 5-8 years' experience (10 years preferred) in Phase 2-4 clinical development in the pharmaceutical industry, practical experience in clinical trial strategies, methods and processes. Demonstrated clinical/medical, administrative, and organizational and project management capabilities are required, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside Pfizer.



+ Has an understanding of basic concepts of PK studies and generic drug development.



+ Thorough understanding of local and international regulations applicable to clinical development.



+ Track record of design, oversight and interpretation of clinical studies.



+ Demonstrated scientific productivity (e .g. doctoral thesis, publications, research reports, etc).







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.







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.







Additional Details:



Last Date to Apply for Job: January 14, 2018



This role can be located at NYHQ, Groton, CT, Collegeville, PA or Cambridge, MA.







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