Sr. Director, Clinical Scientist, Rare Disease

ROLE SUMMARY

This position will be housed in the newly formed Evidence Generation 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. The Platform will combine two formerly disparate Pfizer functions to:

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 PHI, 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 Evidence Generation Clinician, Clinical Scientist (CS) Lead will provide leadership in observational study execution including epidemiological, non-interventional, pragmatic and low-interventional studies, research collaborations and data analyses ensuring consistency of approach, conduct, monitoring, analysis, reporting and oversight of core team activities within one or more asset programs in a given Therapeutic Area (TA). The CS Lead is the point person for the product in Clinical Affairs. The CS Lead may have 1-4 direct reports/contractors to manage for support of the product suite of observational study execution.

In collaboration with Clinical Epidemiology/Scientific Affairs (SA), Medical Affairs (MA), Biostatistics and Clinical Affairs (CA) Operations, the CS Lead is responsible for execution and project management of their studies as well as overseeing the studies of other CS supporting the product. The CS will collaborate with other Pfizer groups to execute the hands-on study execution. The CS will be responsible for numerous observational and epidemiological studies run as Pfizer-sponsored and/or as non-Pfizer sponsored Research Collaborations.

CS Lead is a global position and may support all types of studies/projects in any region (US, IDM, EM, China).

As co-lead of the Study Core Team the CS Lead will lead via a matrix organization Clinical Epidemiology, RWE, Biostats, Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members. The CS Lead also has a significant strategic role in partnership with 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 Evidence Generation Platform is critical to support clinical development planning for Phase 3 efficacy trials (determine incidence/attack rates and risk groups, identify trial sites), obtain optimum Vaccine Technical Committee recommendations/schedules, secure favorable reimbursement, enhance the label and to satisfy post-licensure effectiveness regulatory commitments.

ROLE RESPONSIBILITIES

• Will serve as Clinical Scientist Lead for a given asset with strategic and asset level responsibility beyond managing studies
• The CS is responsible for leading end to end numerous epidemiological studies across various SOPs (for each study): 1) protocol and 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, quality, data integrity, safety, and alignment with company values.
• The CS will work in a global environment on studies across all regions including Emerging Markets and China.
• Represents TA Clinical Affairs line in program-wide functions 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 line management support for other Clinical Scientists within the program. Reviews work, develops staff, ensures appropriate succession planning, and provides ongoing feedback. Responsible for short- and long-term resource planning, priority setting, and filling of resource and skill gaps to address the needs of the program(s).
• Using expert knowledge of epidemiologic/observational and TA 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 staff decisions and is viewed as the Subject Matter Expert on CS decisions impacting a program and potentially the Epi and Medical/Scientific Affairs groups.
• Collaborates with Epidemiology/Medical/Scientific/RWE 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 Lead and Medical/Epi Lead, prepare strategy decisions, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings.
• Represents TA Clinical Affairs and may take the lead on company-wide, global process improvement initiatives, and champions process enhancements and solutions for complex issues. Leads change for Clinical Affairs on new company initiatives

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 15+ years practical experience or MS/MBA with 13+ years, PharmD/PhD 8+ years and MD/DO with 5+ years.
• Has significant years of strong hands-on experience in epidemiology study design, conduct and analysis.
• Experience working on multinational teams/studies
• 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
• 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 solid knowledge of therapeutic area
• 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 studies
• Has exceptional written and oral communication and cross-functional collaborative skills

PREFERRED QUALIFICATIONS

• MS or PhD preferred,
• Has experience in working in emerging markets countries
• Is proficient in MS Word, Excel, and Powerpoint
• Prior therapeutic experience
• Has worked in Industry

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position requires travel (15-25%) includes domestic and global travel.

Other Job Details:

Last Date to Apply for Job: March 31st, 2023

Additional Location Information: US - remote

Eligible for Relocation Package: No

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The annual base salary for this position ranges from $185,800.00 to $309,600.00. In addition, this position offers an annual bonus with a target of 22.5% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

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

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Medical

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