WayUp
Johnson & Johnson, Biomarker & Diagnostic Operations Leader- Oncology - Applicat
WayUp, Cambridge, Massachusetts, us, 02140
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Translational Discovery & Development Biomarkers
Job Category:
Scientific/Technology
All Job Posting Locations:
Spring House, Pennsylvania, United States of America, US337 MA Cambridge - 301 Binney St
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
About Oncology
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Biomarker & Diagnostic Operations Leader- Oncology to be located in Spring House, PA, Raritan, NJ, Cambridge, MA, La Jolla, CA.
We are seeking a highly motivated individual to join the Oncology Biomarker & Diagnostic Operations team. As a key contributor to the clinical biomarker and diagnostic strategy, this individual will be accountable for the implementation and execution of clinical sample collection, testing and data delivery activities for both early and late phase clinical programs in oncology. The successful candidate will have experience bridging both science and operations through cross-functional partnerships, strategic project planning and facilitating key biomarker and diagnostic execution discussions.
Key Responsibilities:
Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology
Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout
Work effectively with procurement and scientific leads to execute contracts and statements of work to meet program deliverables
Contributes to central lab setup and management throughout the course of a study
Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specifications
Works closely with data management to establish data collection and transfer processes with testing vendors and local labs
Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and site training materials
Works with scientific stakeholders to identify innovative bio sample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards
Develops presentations and shares biomarker plan, project timelines, sample tracking/testing metrics at regular team meetings
May work with scientific stakeholders to evaluate and implement new assays and relevant technologies as required by the program
Manages relationships with internal and external partners to ensure on-time and quality deliverables
Participates in cross-functions study team meetings across clinical, translational research and diagnostics.
Qualifications:
A bachelors degree in a scientific/ life science discipline is required.
Additional qualifications: e.g. MS, PhD and/or project management certification desirable. 5+ years of work experience in clinical development, and/or biomarker or diagnostics development and/or Pharmaceutical/biotech R&D Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP required Project management experience is preferred Knowledge of oncology drug development and/or biomarker/diagnostic development is preferred Excellent written and verbal communication skills Ability to effectively and collaboratively work on global cross-functional teams The anticipated base pay range for this position is $104,000 to $166,750. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Holiday pay, including Floating Holidays up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found via the following link: https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. #LI-Hybrid The anticipated base pay range for this position is : Additional Description for Pay Transparency:
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Additional qualifications: e.g. MS, PhD and/or project management certification desirable. 5+ years of work experience in clinical development, and/or biomarker or diagnostics development and/or Pharmaceutical/biotech R&D Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP required Project management experience is preferred Knowledge of oncology drug development and/or biomarker/diagnostic development is preferred Excellent written and verbal communication skills Ability to effectively and collaboratively work on global cross-functional teams The anticipated base pay range for this position is $104,000 to $166,750. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Companys long-term incentive program. Employees are eligible for the following time off benefits: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Holiday pay, including Floating Holidays up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found via the following link: https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. #LI-Hybrid The anticipated base pay range for this position is : Additional Description for Pay Transparency:
#J-18808-Ljbffr