This position will support the Global Clinical Leaders (GCL) in hematological indications for TTI-622, a CD47 blocking agent, within Oncology Clinical Development in the development of the Clinical Development Plan and associated protocol design documents. S/He partners closely with colleagues in other lines to ensure program feasibility and optimized operational planning and may support organization of expert panels and advisory board meetings to provide input into clinical plans, study design or data analysis.
This position will support the hematological indications for TTI-622, a CD47 blocking agent, within Oncology Clinical Development in the development of the Clinical Development Plan and associated protocol design documents. This leader will provide strategic and technical guidance at an asset and or indication level within Oncology Clinical Development, as well as coordination and support to Medical Monitors and non-MD clinicians in CD&O.
Provides therapeutic area clinical expertise to a project(s) and maintains state of the art knowledge in Therapeutic Area.
Provides oncology expertise to the project team to enable clinical interpretation of study data.
This role liaises with Medicine Team Lead, Safety, Regulatory, Translational Oncology, Research, CD&O, and Commercial to support development efforts as needed.ROLE RESPONSIBILITIES
- Provide Clinical Development Leadership among Asset Teams
- Accountable to deliver studies - related to execution and ability to bring in timelines; breadth of the program.
- Point of contact for Clinical Development to Medicine Team Leader for one or more indications or asset .
- Contributes to the Clinical Sub-Team related to assigned assets or indications.
- Supports design, implementation, and interpretation of part of the global clinical program (one or more indications) for a drug candidate to deliver a successful regulatory submission worldwide, working closely with the Clinical Development Leader.
- Drives alignment of regional clinical development strategy with global strategies for the indications he or she is responsible for.
- Contributes to development strategy, by creating and updating the clinical development plan which should integrate well-designed studies with the most efficient use of budget and resources, and risk and quality assessment.
- Leads the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert)
- Signs off clinical documents as required by internal Guidance's/SOPs.
- Leads discussions with regulators and with the resolution of clinical queries from drug regulatory agencies; leads or contributes to writing and review responses to regulatory queries
- Provides clinical input in the preparation and execution of meetings with health authorities.
- Maintains and enhances knowledge in relevant therapeutic or technical areas and in global regulations/guidelines.
- Provides clinical strategy/input to product teams to support marketing and product enhancement/ differentiations efforts, as needed.
- Maintains state of the art knowledge in the tumor-specific therapeutic area
- Creates and maintains a network with key opinion leaders.
- May organize expert panel, consultant or advisory board meetings to provide input to clinical plans.
- May present to senior management, governance committees and external audiences on the clinical aspects of compound development, including milestones, strategies and data, as appropriate.
- Supports licensing initiatives, as appropriate, and as such may design/conduct/review protocols as a member of licensing team.
- Represents the Clinical line on the Publication Sub-Committee and contributes to designing the publication strategy for the asset(s)
- Represents the clinical line on project-related teams and cross-divisional committees
- Reviews ISR proposals.
- Interfaces with other Pfizer sites, other TAs and other functions to share best practices, as appropriate.
Training and Education:
• 10-15 years (MD), unless an accomplished physician with relevant malignant hematology exposure, of experience and track record of success in biopharmaceutical industry in oncology clinical research and development
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
- Clinical Development experience in industry or academic setting
- Demonstrated accomplishments or formal training in oncology
• Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer
• Demonstrated experience managing and guiding large cross-functional teams in clinical development
•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.
Key Competencies and Characteristics:
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Proven ability to operate across a complex matrix environment
- Demonstrated business acumen
- Acts decisively
- People management experience
Global travel required
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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.