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Feasibility Lead Rare Diseases (Director)

Pfizer


Location:
Cambridge, MA 02139
Date:
02/02/2018
2018-02-022018-03-05
Pfizer
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Job Details

Director, Feasibility Lead will be responsible for partnering with Clinical Operations roles, Clinical Lead and CRO to help enable the predictable delivery of Pfizer's portfolio. The candidate will be responsible for driving rapid, accurate and robust assessments of program and protocol feasibility, including timing of key start-up and recruitment milestones and patient recruitment strategies. Focusing on data driven estimates, benchmarking assumptions, robust scenarios & accurate planning. This position will be Rare Diseases specific.







**ROLE RESPONSIBILITIES**







+ Directly supports the Clinical Operations in the build of data driven study Assumptions from operating plan to study work order,



+ Support/advise the CRO Feasibility Process



+ Maintains continuity connecting and documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment & Start Up Planning



+ In support of Clinical Operations, drives early feasibility (before core protocol elements are available)



+ Support Clinical Operations roles early in the development cycle, providing initial enrollment timelines, High Level Budget (Op Plan), potential Country Footprint, develop key assumptions, and establish a patient recruitment strategy.



+ Support Clinical Operation roles in Optimizing Operational Protocol Design and patient centricity



+ Support Clinical Operation roles in ensuring effective scenario generation & planning; comparing Pfizer's past performance data and proposed scenarios from CROs



+ Partner with Clinical Operation Group Leads and CROs to build system, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility (country, site) as well as the timing of key recruitment milestones.



+ Operational accountability for ensuring effective scenario generation & planning comparing Pfizer's past performance data and proposed scenarios from CROs



+ Coordinate organizational resources to support build of data driven study / program assumptions.



+ Support governance processes (OpCo) by providing early feasibility information leveraging existing data sources and organizational knowledge/expertise



+ Partners with CROs, GPD teams, and RU/BU partners to improve overall study start up metrics and implement simple processes.



+ Operational responsibility for delivering to agreed set of KPIs for assigned protocols.



+ Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity



+ Ensures accurate resource forecasting, budget management and delivers cost savings as required



+ Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies



+ Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio delivery,



+ Conduct Patient Recruitment Needs Assessment in conjunction with Study Teams for PFE development programs







**QUALIFICATIONS**







+ A broad based experience clinical research, including clinical trial conduct, Knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations



+ Experience of managing multinational clinical trials is preferred.



+ Experience in assessing Patient Recruitment Needs and building patient recruitment strategies for programs is highly desired



+ Leadership, project/resource management (project, staff, finances), administrative, and technical capabilities are required.



+ History of success in a customer service role with demonstration of meeting customer expectations.



+ Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization



+ Knowledge of Drug development, a thorough understanding of the processes associated with Feasibility, clinical study start-Up and business operations



+ Well-developed strategic planning, observation, analytical operational execution and problem-solving skills



+ Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict







In general, candidates for this job would have the following levels of experience:







+ BS/RN/ MS - 10 years



+ PhD/MD - 6 years







**TECHNICAL SKILLS REQUIREMENTS**







+ Demonstrated knowledge of clinical research processes and regulatory requirements.



+ Demonstrated success/results in prior scientific/administrative management roles including matrix organization



+ Preferred experience of directly managing a team least with direct accountability for performance/or with a direct customer relationship responsibility



+ Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies



+ Demonstrated ability to manage complex projects and cross-functional processes required



+ Demonstrated platform skills; experience presenting to large non-science populations



+ Understands & has demonstrated ability to manage large and complex budget; history of staying on or under budget



+ Demonstrated knowledge of clinical research processes and regulatory requirements.



+ Demonstrated ability to manage complex projects and cross-functional processes required



+ Demonstrated platform skills; experience presenting to large non-science populations







**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.







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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