The goal of the Clinical Research Collaboration Center of Excellence (CRC-CoE) is to partner with academic institutions and their affiliated hospitals and clinics to address areas with clear unmet medical needs. The Center will centralize priority CRCs across Pfizer's portfolio and establish robust connections between Pfizer and the academic community.

As part of the CRC-CoE the non-MD clinician will provide operational and clinical guidance for clinical trial protocol development and execution with collaborating academic partners in the US and ex-US.

Role responsibilities include:

• Partners effectively with the CRC COE Head and clinical lead, RU and GMT stakeholders to co-create clinical trial protocols along with academic partners.
• Partners with CRC team lead and Project manager to lead the clinical due diligence efforts in support of the CRCs.
• Works closely with safety to ensure overall safety of the study and that AEs and SAEs are reported.
• Ensure that medical and scientific milestones timelines and budgets are met.
• Leads clinical due diligence efforts in support of CRC activities.
• Maintain collaborations already in place
• Develops specific clinical development enabling strategies including digital/ innovation and patient engagement approaches.
• Partners with stakeholders on governance reviews for assigned clinical studies. Provides category clinical development strategy input and insights to clinicians for assigned clinical studies.
• Provides therapy area/indication expertise.
• Provides specialized medical monitoring support for study team, if required.
• Support appropriate interpretation and communication of clinical trial data.
• Review and approve submission level safety narrative plan.
• Supports product label development and maintenance
• Engage key external stakeholders e.g., Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates and other external stakeholders, to drive strategic insight generation to support clinical development.
• Ensures compliance with internal SOPs and external regulatory standards.

BASIC QUALIFICATIONS

• Ph.D., with demonstrated depth and breadth of knowledge and experience in clinical research in infectious disease, public health, epidemiology, oncology, internal medicine, immunology, vaccinology, clinical development, or closely related field.
• Advanced degree Ph.D. with 9+ years, MA/MSc 12+ years, or BSc 14+ years of experience in the pharmaceutical industry in key leadership roles of increasing responsibility. Track record of success in biopharmaceutical industry in clinical research and development
• The position will require daily interpretation and communication of clinical, scientific and epidemiological data.
• Clinical science expertise in the academic, clinical practice and/or industry setting.
• Knowledgeable in the R&D process, committed to working with RUs and academic partners to develop clinical research protocols.
• Excellent understanding of related disciplines (e.g. biostatistics, regulatory, clinical pharmacology and precision medicine/biomarkers).
• Documented ability to take a project from start to end including conception, design, protocol, analytic plan, implementation, analysis, and reporting and interpretation of results.
• Demonstrated effective verbal and written communication skills in relating to individuals both inside and outside Pfizer.

PREFERRED QUALIFICATIONS

Extensive knowledge of Pfizer process, clinical development, innovative trial design, global and regional regulation, ICH/GCP, adverse event management

Demonstrated ability to working with RUs/GMTs and academic partners to develop clinical research protocols, assess protocol feasibility, adequacy of resource needs, and participant experience for each proposed trial.

Demonstrated clinical/medical, and administrative capabilities, including close working relationship with project management, and effective communication skills for colleagues/collaborators both within and outside Pfizer.

Competency Requirements

Medical / Scientific credibility/Excellence - Track record of achievement in pharmaceutical development, able to coordinate and execute clinical development across different stages of development including lifecycle strategy. Demonstrated understanding of the complexities of drug development and experience in multiple disease areas to support clinical research collaborations across RU and Global Medical Teams partners confident discussing scientific / mechanistic aspects of drug development, familiarity with commercial and regulatory issues.

Management experience - Able to set priorities and manage cross-functional teams (internal and external) and complex projects to deliver milestones according to set budgets; sets priorities; able to define and manage appropriate resource requirements (budgets and payments) both in-house and vendors / contractors.

Demonstrated experience managing and training large teams in clinical development and experience in designing and launching large teams a plus.

• Demonstrated understanding of related disciplines (e.g. biostatistics, regulatory, clinical pharmacology, safety reporting, and precision medicine/biomarkers.
• Demonstrated ability to learn relevant unique features of study design and execution across targeted disease areas chosen by CRC-COE; confidence discussing scientific/mechanistic aspects of development with collaborators and other CRC COE staff.
• Enthusiasm for learning and implementing the science and processes of regulatory filings.
• Excellent verbal and written communication skills, including concise and detailed writing skills.
• Ability to work and lead independently.
• Ability to work in a highly matrixed organization.
• Strong interpersonal skills.
• Demonstrated strong work ethic, and proven track record of delivering high-quality results within timelines and budgets.
• Documented ability to take a project from start to end including conception, design, protocol, analytic plan, implementation, analysis, and reporting and interpretation of results.
• Demonstrated ability to review, evaluate, interpret, and present complex data.
• Ensures compliance with internal SOPs and external regulatory standards.
• Lead limited-duration teams, as appropriate, for relevant WMS strategic initiatives.
• Accountability: Take personal responsibility for results, pushing self and others to exceed goals and deliver results.
• Change agile: Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change.

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.

PHYSICAL/MENTAL REQUIREMENTS

Mental flexibility with ability to rapidly "shift set" to address simultaneous, multiple studies with collaborators across different therapeutic areas and different mechanisms of action

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel, both domestic and internationally up to 10%.

Work Location Assignment:Flexible

The annual base salary for this position ranges from $156,900.00 to $261,500.00. 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.

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