Director, Clinical Scientist, Oncology

This position will be housed in the newly formed RWE Platform, which is responsible for establishing scientific global leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas and regions. The Platform will:

enhance Pfizer's ability to determine unmet medical needs; support current Product Development programs including finding alternatives and accelerated licensure pathways for new indications through the use of Real World Data (RWD), Real World Insights (RWI) and Real World Evidence (RWE); inform clinical practice on appropriate prescription and use of Pfizer's products; in collaboration with GAV, strengthen the value evidence package for payers and access/policy decision-makers; support measurement of short- and long-term impact of Pfizer's products to both patients and populations; support competitive differentiation.

The RWE Platform Clinical Affairs, Clinical Scientist (CS) will provide leadership in observational study execution including epidemiological, non-interventional, pragmatic and low-interventional studies and research collaborations ensuring consistency of approach, conduct, monitoring, analysis, reporting and oversight of core team activities within one or more asset programs in the Therapeutic Area (TA) of Oncology.

In collaboration with RWE Platform RWE Scientists, Clinical Epidemiology/Scientific Affairs (SA), Medical Affairs (MA), Biostatistics and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies. The CS will collaborate with other Pfizer groups to execute the hands-on work for both in-house and outsourced studies. The CS will be responsible for numerous observational and epidemiological studies run as Pfizer-sponsored and/or as non-Pfizer sponsored Research Collaborations.

The CS is a Platform position and may support all types of studies/projects in any region (US, IDM, EM, China) and for Research Divisions (Pfizer Oncology Division - POD) for in scope work.

As co-lead of the Study Core Team the CS will lead via a matrix organization RWE Platform RWE Scientists/Clinical Epidemiology, QCL, Biostats, Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members. The CS also has a strategic role in partnership with RWE Scientist/Clinical Epi/Medical/Scientific Affairs to develop practical study strategies in support of the product Strategic plans (Clinical Development Plan, Medical/Medicines Plans, E2E, Integrated Evidence Plans etc..) in line with Pfizer SOPs.

Data generated by the RWE Platform is critical to support clinical development planning for Phase 3 efficacy trials (determine incidence/attack rates and risk groups, identify trial sites), secure favorable reimbursement, enhance the label and to satisfy post-licensure effectiveness regulatory commitments.

ROLE RESPONSIBILITIES

• The CS is responsible for leading multiple end to end studies across various SOPs: 1) protocol, study design and training, 2) data review and interpretation, 3) study and/or program scientific and integrity oversight, 4) safety review and communication, 5) regulatory document, study report, and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency (within regions and globally, including common protocols, CRFs, and databases), quality, data integrity, safety, and alignment with company values.
• The CS will work in a global environment on studies across all regions including International, Emerging Markets and China.
• Represents Oncology Clinical Affairs line in program-wide functions and governance on Medical Sub Committee, Clinical Study Teams, various department asset teams, IMAT, and Regulatory Strategy teams. Contributes to discussions to ensure consistency across products/TA.
• May provide matrix oversight for other Clinical Scientists within the program. Reviews work, develops staff, and provides ongoing feedback.
• Using expert knowledge of epidemiologic/observational and specific aspects of trials, provides oversight of operational strategic partner involvement at a program or study level. Identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate working with Clinical Affairs Lead, Clinical Epidemiologist/Medical/Scientific Affairs Lead and Partner representatives.
• Influences management/senior management decisions and is viewed as the Subject Matter Expert on CS decisions impacting a program and potentially the Medical/Scientific Affairs groups.
• Collaborates with Epidemiology/Medical/Scientific Leads and other team members on development of strategic plans and provides input on tactical implementation of studies to support the asset strategies.
• Provides CS leadership role in preparation of regulatory submissions, responses to regulatory queries, and in preparation for program regulatory inspections and audits.
• In collaboration with the Clinical Affairs Lead and Clinical Epidemiology/Medical/Scientific Lead, make study strategic decisions, present and discuss data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
• Represents Clinical Affairs and may take the lead on company-wide, global process improvement initiatives, and champions process enhancements and solutions for complex issues.

BASIC QUALIFICATIONS

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

• BA/BS Degree in life sciences or health related field with 10+ years practical experience or MS/MBA with 8+ years, PharmD/PhD 6+ years and MD/DO with 3+ years.
• Industry experience as a Clinical Scientist or similar capacity.
• Experience working on multinational teams/studies
• Has strong hands-on experience in epidemiology study design, conduct and analysis.
• Has significant experience leading operational and/or strategic study teams
• Has significant experience working independently and collaborating with multiple functional groups within and outside the business line
• Prior oncology research experience
• Has demonstrated an advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols and ensuring they meet strategic program objectives
• Has advanced knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
• Has independently authored clinical protocols and other clinical study documents
• Has working knowledge of statistics, data analysis, and data interpretation
• Has experience in managing external vendors for clinical and/or epidemiological study(ies)
• Fluent in English writing, reading, and speaking and has exceptional written and oral communication and cross-functional collaborative skills.

PREFERRED QUALIFICATIONS

• MS or PhD preferred
• Has experience in working in a global setting
• Is proficient in MS Word, Excel, and PowerPoint

Other Job Details:

Last Date to Apply for Job: March 22nd, 2024

Additional Location Information: New York, NY; Collegeville, PA; Cambridge, MA; Groton, CT; Bothell, WA, Lake Forest, IL; La Jolla, CA

Eligible for Relocation Package: No

#LI-PFE

The annual base salary for this position ranges from $161,600.00 to $269,400.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% 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 | (uscandidates.mypfizerbenefits.com). 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.

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.

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