CAREER PORTAL

Principle Scientist - Biomarkers for Clinical Studies

Principle Scientist – Biomarkers for Clinical Studies
External ID # GSK0JP00107395
Collegeville, PA- HYBRID
6 month W2 contract (with potential to extend or transition to perm)
Pay rate: $53-65/hr - Depending on Education and Experience

**Hybrid: 2 days onsite/3 days remote**
Summary:
As Principle Scientist PMed Operations Specializing in Biomarker Bioanalytical Platforms
(BBP), you will lead the planning activities across various scientific lab groups in BBP for all
BBP-owned measures (Pharmacokinetics, Immunogenicity including ADA and NAb, PD
Biomarkers, Diagnostic Biomarkers, and Exploratory Biomarkers) to support clinical study
milestones. You will act as an operations BBP contact for asset-driven clinical study/project
teams on all planning activities, including analytical timelines, budgeting, and scientific
coordination.

Responsibilities:

• Lead planning activities across various scientific lab groups in BBP for all BBP
  owned measures to support clinical study milestones.
• Act as an operations BBP contact for asset-driven clinical study/project teams on all
  planning activities, including analytical timelines, budgeting, and scientific
  coordination.
• Coordinate the bioanalytical portion of clinical study support conducted in-house or
  at CROs, focusing on required clinical assay measure deliverables, resource and
  budgetary requirements, and protocol review for contract generation.
• Oversee the coordination of assay requirements, reagent development, resource
  placement, and performance tracking for GSK clinical studies.
• Provide regular study level status updates for areas of accountability/responsibility to key stakeholders as required.
• Work with Project Managers to deliver an accurate project plan for clinical study
  assay measures, provide budget and resource forecasting, invoice approval, and
  keep the project plan live throughout the study.
• Support the provision of productivity, resource, and capacity data and analysis for
  the Biomarker Platforms’ Leadership Team.
• Track progress, business performance, concern escalation, and issue resolutions
  on all BBP deliverables to study/project teams for both internally and externally
  supported project work.
• Interface with scientific leads to determine CRO selection and provide invoice
  approvals for executed work.
• Understand and meet the requirements of all relevant GSK policies, SOPs, and
  external regulations, and comply with local codes of practice, guidelines, and laws.
• Contribute to functional process and system improvements to ensure operational
  excellence.
• Support biomarker or other activities as required.
• Contribute to a positive and motivating work environment that encourages mutual
  respect, innovation, and accountability at all levels through role modelling the GSK
  values.

Skills or Requirements:
Basic Qualifications:

• Bachelor’s or master’s degree in Biological/Chemical/Pharmaceutical Sciences,
  Business, or Project Management.
• Experience with clinical PK Bioanalysis, PD Biomarker, Exploratory Biomarker,
  Immunogenicity, and/or cellular assay delivery requirements.
• At least 3 years of related experience

Preferred Qualifications:

• Knowledge of the drug development process, especially of biotherapeutics, as it
  applies to technical, logistical, and regulatory requirements for PK bioanalytical,
  immunogenicity, PD biomarker, and exploratory biomarker assays across multiple
  technical platforms.
• Experience representing the bioanalytical function and driving/delivering
  bioanalytical strategies and commitments to clinical study teams in a highly matrixed
  environment.
• Experience coordinating multiple demands and timelines (> 6 assets or 30+ clinical
  studies), stakeholder influence, and managing expectations.
• Excellent organizational, interpersonal, and written/verbal communication skills with
  internal and external partners.
• Experience in working with leaders to define project/study strategies and
  deliverables.
• Strong understanding of regulatory guidelines from health authorities and previous
  work experience of GLP, GCP, and/or GMP.
• Strong understanding of clinical PK Bioanalysis, PD Biomarker, Exploratory
  Biomarker, Immunogenicity, and/or cellular assay technical limitations.
   

What’s In It For You?
We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs

Estimated Min Rate: $45.50
Estimated Max Rate: $65.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

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