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 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 5+ years practical experience or MS/MBA with 3+ years, PharmD/PhD 2 years, MD/DO with 1 year
• Industry experience in the Clinical Scientist or similar capacity.
• Experience working on multinational teams/studies
• Has some hands-on experience in epidemiology study design, conduct and analysis.
• Has experience in or leading study teams
• Has experience working independently and collaborating with multiple functional groups within and outside the business line
• Has worked in industry
• Has demonstrated an ability working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols
• Has strong 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

• Has experience in working in a global setting
• Is proficient in MS Word, Excel, and PowerPoint
• Prior therapeutic area experience

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position requires travel (10%) both domestic and international. Weekend and evening work likely to be required based on project needs as needed but the exception rather than rule.

LAST DAY TO APPLY: AUGUST 31st 2024

Purpose 

Breakthroughs that change patients’ lives… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. 

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility 

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! 

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

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