Sr. Manager, Clinical Scientist

ROLE SUMMARY

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 support and leadership for conduct of 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). 

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 (PRD, ORD, VRD) 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 Sr. Manager is responsible for supporting complex or leading low complexity 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.

• May represent TA Clinical Affairs line in program-wide functions and governance on Medical Sub Committee, Clinical Study Teams, various department asset teams and Regulatory Strategy teams. Contributes to discussions to ensure consistency across products/TA.

• Using knowledge of epidemiologic/observational and specific aspects of trials, provides support of operational strategic partner involvement at a program or study level. Identifies issues in a timely manner, leads implementation of solutions, and/or escalates as appropriate working with Clinical Affairs Lead CS, RWE Scientist, Clinical Epidemiologist/Medical/Scientific Affairs Lead and Partner representatives. 

• Provides operational input on tactical implementation of studies to support the asset strategies.

• Provides CS leadership role in preparation of regulatory submissions and in preparation for program regulatory inspections and audits.

• In collaboration with the Clinical Affairs Lead and Clinical Epidemiology/Medical/Scientific Lead, present and discuss data at rele