You will be responsible for defining late-stage development and ensuring continuity of the overarching clinical biomarker strategy.
You will work collaboratively across medical, early translational medicine, clinical and research teams as well as partnering closely with biostatistics, relevant Key Opinion Leaders (KOLs) and biomarker assay leads to establish end to end clinical biomarker strategy that will support efficacy, safety, patient/dose selection, potential companion diagnostics assays and submissions.
You will leverage your deep understanding of disease biology and relevant biomarkers and experience in execution of clinical trials to help design late-stage clinical translational biomarker plans and support post marketing questions.ROLE RESPONSIBILITIES
- Collaborates with clinical, research, and partner line colleagues to develop a late-stage biomarker plan that includes transition of selected biomarkers from proof-of-concept trials that will support submission, label or/and influencing medical community.
- Identify, evaluate, and prioritize candidate predictive biomarkers and enable the development of potential clinical companion diagnostic tests that will appropriately transition from early to late phase clinical development.
- Work directly with academic collaborators and key opinion leaders to refine clinical translational research efforts.
- Work collaboratively within highly matrixed, multi-functional Global Medicine Teams and across organizational boundaries to successfully achieve goals and deliverables ensuring prioritization of science-driven drug development.
- Serves as a member of the clinical study team to interpret biomarker results in the context of the clinical study.
- Scientifically evaluates complex data able to appropriately guide study teams through complex issues resolution.
As appropriate, additional responsibilities may include the following:
- Establish visibility with key stakeholders and the scientific community through external and internal presentations and peer-reviewed publications.
- Maintains up-to-date knowledge of disease area clinical research, global regulatory guidance's & expectations, and industry best practices.
- Supports challenging clinical trials and programs involving novel modalities, cross-company collaborations and/or external partnerships.
- Interface with external biomarker consortia and initiatives
- As SME, assists clinical pharmacology leads and medical affairs in conducting due diligence activities.
- Leads internal and cross-functional organization initiatives, development and implementation of the relevant policies and best practices and demonstrates internal and external influence.
- Provides subject matter expertise, guidance and mentoring to colleagues.
- PhD in biology, molecular biology, immunology, pharmacology or related field and research background in a relevant disease area with minimum of 10 years clinical biomarker development and translational medicine strategy development.
- Demonstrated and current experience in disease biology and relevant genetics in one or more therapeutic areas including: Infectious diseases, Rare diseases, Inflammatory and Immunologic diseases and Metabolic and Cardiovascular disease.
- Experience desiging, initiating and conducting clinical studies focusing on integrating and executing biomarker plans that support clinical development objectives.
- Experience in clinical protocol design, late-stage clinical development, clinical trial operations, clinical validation of biomarker assays, and interaction with KOLs
- Working knowledge of biomarker measurement methods such as NGS, IHC, qPCR, FISH, FACS, and other technologies and related data analysis tools.
- Direct experience interacting with regulatory authorities and supporting regulatory submissions & regulatory queries, and inspections.
- Demonstrated ability to think strategically, work effectively in a highly matrixed environment, and execute multiple projects simultaneously.
- Strong communication skills: verbal, written, and presentation.
- Experience presenting clinical data, study plans and strategy to relevant audiences to inform and direct decisions.
- Understanding of clinical pharmacology, PK/PD and MIDD.
- Understanding of pre-clinical and clinical biology, and the ability to apply that knowledge to drug development.
- Good understanding of steps required for biomarker assay analytical validation, and sample analyses.
- Experience with training and mentoring colleagues.
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.
Relocation support available
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.
\nPfizer 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.