Director, Immuno-Oncology MD Medical Monitor

Org Marketing Statement

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description

Overall Mission and Goal:

* Applies medical and clinical development knowledge to transform clinical research ideas into

high quality clinical recommendations.

* In collaboration with individual study clinicians, 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, 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.

Therapy Area:

* Provides therapeutic area clinical expertise to a project.

* Keeps the Oncology Clinical Development community aligned and cohesive across sites,

projects, and assets.

* Collaborates on the implementation of cross-site initiatives in collaboration with individual

study clinicians.

Responsibilities

Program-Related:

* Leads or assists in the preparations of the clinical content of regulatory submissions/documents

(e.g., NDA, MAA, IND, sNDA, IB, AR/DSRU, CDS, PI)

* Assists in discussions with regulators and leads or contributes to health authority (HA) query

response writing, review, and resolution.

* Provides clinical input into the preparation and execution of meetings with HAs.

* Works with Global Clinical Lead and (Asset) Team Lead to ensure that the assigned studies

fulfill their role in the overall Clinical Development Plan.

* Maintains and enhances knowledge in relevant therapeutic or technical areas and in global

regulations/guidelines.

* Provides Clinical/Medical input to other departments (e.g., WRD, Medical Affairs,

Commercial) to support asset development as well as marketing and product enhancement/

differentiations efforts as needed.

* May organize expert panel, consultant or advisory board meetings to provide input to clinical

development plans.

* May be an active member of an alliance partnership team.

* May present to senior management, governance committees, and external audiences on the

clinical aspects of asset development, including milestones, strategies, and clinical trial data, as

appropriate.

* Represents the Clinical line on project-related teams and cross-divisional committees (e.g.,

TRC, PQRC)

* Reviews IIR proposals upon special request based on subject matter expertise.

* Interfaces with other Pfizer sites, other TAs, and other functions to share best practices, as

appropriate

* Early Development clinical studies only) Responsible for the Safety Surveillance and Risk

Management (SSRM) component of the Asset Development Plan until achievement of POC, in

agreement with SOP SAF09 and in collaboration with the SRL.

People-Related:

* Motivates and engages colleagues to understand a disease, and communicates commitment and

excitement about an indication and/or mechanism of action.

* May coach and mentor less experienced Medical Monitors, Study Clinicians, and Clinical

Study Subteam Members.

* May manage direct reports, including performance management and career development

(recruiting, retaining and developing top talent)

Therapeutic Area:

* Independently maintains state of the art knowledge in the therapeutic area.

* With line management endorsement, manages and initiates external collaborations to develop

new methodologies and to investigate mechanisms relevant to the therapeutic area.

Study Planning and Facilitation

* Creates or supports study protocol creation from outline to final protocol in collaboration with a

Study Clinician and the GCL.

* Contributes to study outlines and provides medical expertise to development of clinical

protocols.

* Promotes novel approaches in study designs and through application of enhanced clinical trial

design, ensuring the most efficient clinical protocols are developed.

* Reviews the Informed Consent Document (ICD) template in collaboration with the study

clinician

* Reviews and approves the risk section of the Informed Consent Document (ICD) template.

* Provides clinical input to study teams on CRF design, statistical analysis plan, monitoring

guidelines, Data Review Plan, and IQMP as needed.

* Reviews and addresses significant protocol deviations (PD), PD trends and Quality Qualifying

Issues

* Supports other lines (e.g., Development Operations) to ensure that the budget fits within the

overall development plan in collaboration with individual study clinicians.

* Works with Development Operations and/or the AP and RMMs/RMRSs 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.

* Liaises with IOBU-SDMC, E-DMC, and Steering Committee as required by the protocol.

* May lead or oversee compassionate-use programs.

Study Conduct and Monitoring

* Ensures adherence to Safety Review Plan (SRP).

* May perform and document the regular review of individual subject safety data. The specific

components of safety data review are detailed in the Safety Data Review Guide -- for Clinicians,

and in SOP SAF09.

* Tracks emerging efficacy and safety profile of the drug.

* Must be fully knowledgeable about the safety profile of allocated drugs on which studies are

being conducted, or which are called for in the protocol.

* May serve as principal contact on scientific and medical issues for Development Operations,

study managers/monitors, external collaborators, and study sites during the conduct of the

clinical trial.

* Leads contact with PIs about safety issues Supports protocol amendments, as necessary, to

address safety, efficacy or operational issues.

* May be responsible for the clinical section of the Trial Master File.

Study Analysis and Reporting

* Works with biometrics and other clinical staff (e.g., Clinical Pharmacology) in the review and

interpretation of data in collaboration with individual study clinicians.

* Is responsible for medical and scientific validity of the clinical study report, especially

conclusions regarding efficacy and safety.

* May co-author abstracts, posters, presentations, and publications.

Qualifications

Training & Education:

Required:

* MD with minimum of 3+ years of clinical 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 (and/or Immuno-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.

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.