RWE VP Lead Clinical Operations

ROLE SUMMARY

The VP of Clinical Operations in the CMAO RWE Platform leads a global Clinical Operations (C&O) organization to support the implementation of observational Pfizer enterprise evidence generation and all Medical Affairs RWE research agendas across all categories and all regions, IDM, EM and China. In addition, C&O will oversee operational support for work from PRD and other areas of Pfizer including a broad portfolio of regulatory submission studies for label change, committed PASS, PMS, HTA requirements and post marketing commitments. The RWE Platform extends support for RWE generation beyond the CMAO.

C&O will conduct studies to support the Integrated Evidence Plans (IEP) and strategic goals of all regions including IDM and EM. All study types are within remit including regulatory and non-regulatory Research Collaborations, interventional studies, non-interventional, low interventional, pragmatic, registries and epidemiological studies. The C&O VP partners with other RWE Platform VP lines, Category CMAOs, Platform CMAOs, Enterprise VP and Presidents, Medical Affairs leads, Safety, CD&O, PRD, GSSO, other leaders in early and late phase development, Global Health &Value to develop and execute strategies to deliver the IEP study deliverables. Along with the other pillars of Evidence Generation, the C&O VP will build collaborative bridges across TAs to provide high quality support for development and execution of the TA, US and International priority markets and products in line with the enterprise needs.

The C&O VP responds to the dynamic business needs to ensure appropriate resourcing across all assets and regions to deliver innovative, high-quality, cost efficient, clinical and epidemiological studies.

The C&O VP is a Study Matter Expert within observational clinical epidemiology study conduct and as such will provide guidance and oversight of Clinical Operations activities for all TAs. Each TA Clinical Operations Head will report to the C&O VP.

Via collaboration with the RWE Platform Quality and Compliance group will establish global consistency, governance and compliance by developing fit for purpose training, oversight, processes/procedures and updating of existing SOPs to adjust for innovation and high-quality evidence generation. The C&O VP as part of the RWE Platform and in conjunction with the other Platform functions will build and continuously improve the delivery of high quality, efficient and consistent evidence generation across the Pfizer enterprise for the main customers including: CMAO, PRD, GAV and CAI.

Strategic Asset Level Across all TAs

• Determine needs of TAs/CMAOs/International, work cross-functionally to build the Evidence Generation machinery to provide world class medical data.
• Oversee the Clinical Operations groups to execute and deliver high quality studies in accordance with category priority. CA will lead core study teams, generation and approval of study documents, protocol development/approval, provide operational support as per study type (SOP) and needs; control budget and timelines of program activities; and ensure adherence to the highest quality and compliance standards in accordance with Pfizer SOPs.
• Oversee adherence to integrated ways of working to ensure Clinical Operations has a seat at the table to provide operational guidance and input during development of concepts, strategies, Operational Plans and updates to the IEP.
• Develop an enhanced collaborative, compliant and innovative work environment across the CMAOs, TAs and line partners for more efficient, less costly evidence generation.
• Establish new qualitative metrics to supplement standard quantitative metrics that will create a feedback loop for constant improvement in the quality of work by CMAO and Platforms in study design and execution.
• Ensure that inputs from all members, regions, lines and management are heard, validated and considered throughout the execution of the asset evidence generation.
• In close collaboration with the Platform Quality and Compliance function ensure appropriate quality/compliance training, ongoing education, monitoring, remediation and improvements are implemented across TAs. Create/modify SOPs to meet needs of unique work in Evidence Generation arena.
• With the Platform & Partnerships and Quality & Compliance pillars create a novel and desperately needed Enterprise tool in KIMS for managing, measuring, reporting and documenting all work product supported by the platform. Leverage the tool for quality improvement, cost savings, return on investment, speed to completion, adherence to governance, alignment to priority and metrics that span every aspect of the work both quantitatively and qualitatively.
• Provides leadership for Clinical Operations organizations to incorporate innovation, efficient and/or creative observational elements across all study types.
• In Partnership with CMAO, Platform Business Operations and the Medical Excellence Platform establish a robust Governance framework and consistent implementation of study and protocol approval and resourcing via the Evidence Generation Sub Committees.

Enterprise

• Identify opportunities for Consistency, improvement and Standards for Evidence Generation approaches and processes within regions and across TAs, and supporting the piloting and implementation of such.
• Create Pfizer epidemiological database standards for use across assets.
• Innovating, championing and implementing Novel Approaches to research.
• Manage key inter-divisional interfaces on program issues including CMAO, Medical Affairs, PRD/ORD, Global Health and Value, Safety, Regional organizations and other key partners.
• Engage executive leadership regarding strategic issues, project plans, quality aspects, options and recommendations to support uninterrupted program execution with efficiency.
• Work with project leaders and managers in Research & Development and/or with licensing partners to ensure a seamless transition of acquired products.

Managerial

• Partners seamlessly with other RWE Platform line leaders and Pfizer Enterprise VP and division leaders.
• Effectively manages direct lines.
• Assigning the "right colleague to the right project at the right time".
• Ensure proper training, implement team building and foster development of colleagues and leaders.
• Motivates and engages the Clinical colleagues in understanding the Enterprise Blueprint and CMAO strategy to maintain their commitment, and excitement.
• Coaches and mentors in/outside of direct line.
• Ensures compliance with SOP and Pfizer policy training requirements.

BASIC QUALIFICATIONS

• A minimum of 20+ years of direct experience is required for candidates with a Bachelor's Degree in life sciences or a health-related field, 18 years for those with a Master's Degree, or 15 years for those with a Ph.D.
• Leadership, project management, resource management, administrative, and technical capabilities are required.
• Ability in, and track record of, working effectively in an advanced matrix structure including matrix team leadership/representation.
• Forward planning and anticipation of the needs of the individual and the Asset or Region.
• Has vision to see and skills to create a more efficient, compliant and integrated future and lead a path towards it.
• Motivates colleagues through example, commitment, loyalty and enthusiasm.
• Utilizes and encourages innovative approaches
• Influences Internal and external stakeholders
• Able to act independently, seeking guidance as appropriate. Demonstrates leadership in day-to- day activities.
• Demonstrate ability to:
• Recognizes other colleagues' areas of expertise and utilizes them effectively to achieve team objectives. Runs effective meetings, including all colleagues' diverse opinions and bringing group to consensus.
• Strong Matrix partnering, inclusiveness and collaborative working relationships

PREFERRED QUALIFICATIONS

• Working effectively when co-located with, and when remote from, asset teams/leaders/managers and reports.
• Championing high quality deliverables, and innovation.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
• Effective interactions with key external subject matter experts including regulatory authorities.
• Comprehensive knowledge of drug development process. Clinical development and post -marketing experience
• Has strong experience in observational epidemiology study design, conduct and analysis
• Can handle more than one complex project simultaneously, prioritizing well and recognizing key issues.

OTHER JOB DETAILS:

Last Date to Apply for Job: August 23, 2024

Additional Location Information: New York, NY; Collegeville, PA; Cambridge, MA; Groton, CT; Bothell, WA, Lake Forest, IL; La Jolla, CA; Tampa, FL; San Francisco, CA; Memphis, TN; North America - Any Pfizer site; Europe - Any Pfizer site

The annual base salary for this position ranges from $262,100.00 to $436,800.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

• The annual base salary for this position in Tampa, FL ranges from $235,900.00 to $393,100.00.

Relocation assistance may be available based on business needs and/or eligibility.

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.

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. This position requires permanent work authorization in the United States.

Medical