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Sr. Manager, Precision Medicine, Clinical Biomarkers

Employer
Pfizer
Location
Cambridge, MA
Start date
Aug 4, 2022

View more

Discipline
Clinical, Clinical Research
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Genetown, Best Places to Work
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Job Details

Role Description

The Clinical Biomarker Lead for Infectious Disease (ID) works collaboratively across clinical, technical, and research teams to drive precision medicine ID strategies for proof of mechanism, patient stratification, differentiation and surveillance. The lead partners with biomarker stakeholders to deliver portfolio goals for ID assets. The Clinical Biomarker Lead will establish and coordinate interactions between clinical and research project teams, assay specialists, statisticians, CRO’s, PM Clinical Biomarker Laboratories, and the internal biomarker community. A successful candidate can coordinate and lead within a cross-disciplined, matrix team organization, multitask/prioritize multiple projects, and leverage existing information to deliver effective, fit for purpose ID biomarker strategies, quality data, and interpretation of biomarker results to drive early clinical development. In addition, the Clinical Biomarker Lead will present and share project status, issues, and learnings to all stakeholders to ensure a culture of transparency, innovation, and continuous improvement.

Role Responsibilities

  • Collaborates with clinical, research, and partner line colleagues in the infectious disease research unit to develop and defend scientifically rigorous translational biomarker strategies supporting proof of mechanism, emerging resistance, early signs of efficacy, proof of concept, patient stratification/selection, differentiation, diagnosis and surveillance.
  • Assembles and leads collaborative biomarker sub-teams to develop/refine biomarker strategies, interpret data and operationalize biomarker strategy.
  • Experience with ID biomarker technologies including assessment of pathogen nucleic acids by quantitative PCR, metagenomic/NGS sequencing, T cell/ELIspot, infectious titer output, host proteomic/transcriptomic/metabolomic profiling and treatment emergent mutation analysis.
  • Contributes to biomarker sections of clinical development plans, clinical protocols, lab manuals, Informed consents, briefing documents and other registration level documents.
  • Participates in above asset initiatives such as phase 0 natural history and methodology studies to help expand and sustain the portfolio pipeline.
  • Serves on clinical operations teams to ensure compliance on biomarker specimen management, data-sample reconciliations and on-time delivery of biomarker data.
  • Works with biomarker, clinical, medical and regulatory teams to interpret biomarker results in the context of the clinical study.
  • Shares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications.

Qualifications

  • BASIC QUALIFICATIONS

    Education

  • PhD, MD, MD/PhD and/or PharmD preferred. MS considered if 7+ experience and demonstrated leadership skills.
  • Primary

  • Strong infectious (fungal, viral, bacterial) disease, microbiology, immunology background.
  • 1-5+ years of experience in pharmaceutical discovery, all biomarker technologies and/or exploratory clinical research
  • Background and applied experience in regulated and non-regulated biomarker technologies including genomics, proteomics, mass spectrometry, ligand binding immunoassay and flow cytometry.
  • Experience working with cross-functional clinical study teams to deliver asset and platform specific translational biomarker strategies.
  • Able to work cross-functionally to develop solutions to complex, translational issues within and beyond category area expertise.
  • Ability to work in complex matrix environment with a rapidly changing strategies with many diverse stakeholders
  • Demonstrated teambuilding, relationship-management, negotiating and talent management skills
  • Demonstrated written and communication skills Good external presence and network, with a solid track record of scientific publications, external presentations, and effective external collaborations
  • Solid track record of effectively working and communicating in a fast-paced environment with multi-disciplinary scientists, researchers and non-scientists, both internally and externally
  • Preferred

  • Working knowledge of a broad range of biomarker technologies andan understanding of validation requirements, implementation into clinical trials and interpretation of multi-variate pharmacogenomics and/or biomarker data
  • Basic knowledge of disease pathophysiology in the following areas: Immunology/autoimmune indication adjacencies (e.g. fibrosis, diabetes, rare disease).
  • Some understanding of development of diagnostic assay development and regulation requirements.

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.

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.

Other Job Details:

  • Last Date to Apply for Job: August 1, 2018
  • Eligible for Relocation Package: yes
  • Eligible for Employee Referral Bonus: yes

Work Location Assignment:Flexible

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.

PHYSICAL/MENTAL REQUIREMENTS

Primarily sitting at a desk and moving through offices. Light-to-moderate travel load. No extra-ordinary requirements. Can work hybrid


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Occasional travel as required

Relocation support available

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.

Medical

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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