Director, Study Clinician - MD, Medical Monitor

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. • Applies medical and clinical development knowledge to transform clinical research ideas into high-quality clinical recommendations. • Executes the development of the clinical strategy for studies and projects with a focus on innovative design, medical execution and interpretations in collaboration with individual study clinicians. • In collaboration with individual study clinicians, assesses eligibility of patients for one or more studies. • Conducts clinical review of study data (includes safety, efficacy, overall consistency, and finalization of CAPAs) in collaboration with individual study clinicians. • Provides therapeutic area clinical expertise to a project.

• Provides medical oversight and medical guidance as required for Investigator Brochure review, Informed Consent Document review, protocol review, safety data review, protocol deviation review, clinical study report review, and regulatory submissions. • Provides clinical input to study teams on Case Report Form design, statistical analysis plan, monitoring guidelines, Data Review Plan, and Integrated Quality Management Plan as needed, and tracks emerging efficacy and safety profile of the drug. • Works with Development Operations, Clinical Research Organizations and Regional Medical Monitors to identify, evaluate, and select clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a time- and cost-effective manner and to enable quality, compliance and patient safety at the trial, site and patient level. • Partners with Regional Medical Monitors (RMMs) in the development of the RMM Medical Oversight Plan (for studies designated as ‘high medical risk’). • Partners with the Safety Risk Leads (SRLs) to ensure effective and timely completion and documentation of targeted medical events, cumulative and aggregate safety reviews. • Provides medical monitor advise to address medical questions/problems which may arise (e.g. eligibility questions) to enable quality, compliance and patient safety. • Reviews and addresses significant protocol deviations (PD), PD trends and Significant Quality Events. • Reviews Investigator Initiated Research and Compassionate/Extended Use proposals upon special request based on subject matter expertise. • Prepares the Safety Surveillance and Risk Management (SSRM) component of the Asset Development Plan for assets in the early development phase.

**Required:** • MD with minimum of 3+ years of Oncology clinical trial experience. • Demonstrated technical, administrative, and project management capabilities, as well as effective verbal and written communication skills plus ability to relate well to colleagues and associates both inside and outside the company. **Preferred:** • Prior industry Oncology clinical development or equivalent experience. • Postgraduate training/certification/fellowship in Medical Oncology and/or Hematology • Demonstrated scientific productivity (e.g., publications, research reports, etc.) • Thorough understanding of local and international regulations applicable to clinical development. • Practical experience in clinical trial strategies, methods, and processes. • Track record of designing and interpreting excellent focused development plans and clinical studies. • Experience with regulatory submissions. **Technical Competencies-Specific Skills:** • Potential or ability to design, initiate, and conduct clinical studies • Demonstrated technical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the corporation • Ability to review and understand the emerging safety and efficacy profile of the drug candidate. • Demonstrated understanding of the complexities and recent developments in the relevant therapeutic/technical area, and the ability to apply such knowledge to drug development • Demonstrated ability to present clinical data, study plans and tactics clearly and accurately to relevant audiences in order to enhance decision making.