- This position will be the global clinical lead for a medicine with one or more indications within the Oncology Research and Development organization and will provide strategic and technical guidance at an asset and/or indication level, as well as coordination and support to Oncology Clinical Leads, Medical Monitors and non-MD clinicians.
- Provides therapeutic area clinical expertise to a project(s) andmaintains state of the art knowledge in Prostate Cancer.
- Provides oncology expertise and clinical leadership to the Global Medicine Teams.
Contribution to Projects:
- Accountable for developing and delivering the integrated clinical development plan that is consistent with the overarching strategy and vision for prostate cancer, with well-designed studies and the most efficient use of budget and resources, and risk and quality assessment.
- Leads design, implementation, and interpretation of pivotal studies as 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 Development Head.
- Single point of contact for Clinical Development to the Medicine Team, and leader of the Clinical Sub-Team related to assigned assets or indications.
- 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).
- Provides clinical input in the preparation and execution of meetings with health authorities, including leading discussions with regulators and leading/contributing to regulatory query responses.
- Maintains and enhances knowledge in relevant therapeutic or technical areas and in global regulations/guidelines.
- Creates and maintains a network with key opinion leaders.
- 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.
- Supports business development initiatives, as appropriate, and as such may design/conduct/review protocols as a member of a due diligence team.
- Represents the Clinical line on the Publication Sub-Committee and contributes to designing the publication strategy for the asset(s), including review of abstracts, posters, and presentations and ISRs for for scientific meetings and publications.
- Represents the clinical line on project-related teams and cross-divisional committees.
- Interfaces with other Pfizer sites, other TAs and other functions to share best practices, as appropriate.
- This position may have direct reports, including oncology clinical leads and clinicians
- Articulate, inspiring, and decisive leader who can apply cost effective, time efficient and high-quality approaches to drug development.
- Excellent presentation, written and oral communication skills with the ability to adapt and deliver effective presentations in a wide variety of settings and audiences, tailoring presentations to the knowledge level of the audience to suits needs and maximize understanding.
- Significant degree of independence, willing to take on special projects; unique study designs such as incorporating RWE.
- Development and Fostering of Clinical Development Best Practices by establishing an effective network within the Pfizer ORD community, ensuring sharing of knowledge and best practices.
- Facilitate transparent and regular communication with Medical Monitors and non-MD clinicians with regard to study status to surface key risks and opportunities, escalating unresolved issues to the Development leadership.
Training and Education:
- MD or MD/PhD
- Board certified/eligible in Oncology or equivalent qualification
- Prior development or academic expertise in prostate cancer required.
- Strong academic background as showcased through multiple publications in peer reviewed journals, strongly preferred.
- Demonstrated accomplishments or formal training in Oncology
- 10+ years of clinical development experience in the health sciences, preferably GU oncology stretching academic and industry career.
- 2+ years pharmaceutical industry experience (minimum depending on academic experience prior to industry)
Key Competencies and Characteristics:
- IND/NDA/MAA submission experience (absolute requirement)
- Proven ability to lead a team in a complex matrix environment
- Demonstrated business acumen
- Acts decisively
- People management experience
Location is hybrid - must be on site 2.5 days per week.
The annual base salary for this position ranges from $270,800.00 to $451,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 30.0% 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
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