Senior Scientist, Biomarker Operations, Project Management

Job Description

We are currently seeking a Senior Scientist within the Integrated Biomarker Operations organization to provide biomarker Project Management and operational expertise to support cross-functional clinical teams, ensuring the timely and efficient delivery of the biomarker operational aspects of each study.

This position will report into the Associate Principal Scientist of Project Management and be based either at Upper Gwynedd, PA or Rahway, NJ site.

You will have experience in clinical biomarker assay execution and demonstrated success in Project Management. As a key contributor to the clinical biomarker strategy, you will be accountable for planning, implementation, and execution of clinical biomarker specimen collection, testing and data delivery activities in clinical studies. The primary focus of this position is in oncology, although support of other disease areas may be required as therapeutic focus evolves.

The successful candidate will work closely with Biomarker leads, Assay scientists, Vendor Managers and Clinical team to ensure that critical timelines are meet by our vendors. You will also monitor Integrated Biomarker Operations processes, identify opportunities for improvement, and implement strategic solutions to ensure excellence in service delivery.

The selected candidate will have strong verbal and written communication skills and be expected to work independently in a highly collaborative and matrixed environment. You will excel under fast paced and fluid conditions and be a strong advocate for operational excellence.

Primary responsibilities include, but are not limited to:

• Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient trial execution
• Be the operational partner to the Biomarker scientific leads to aid in implementing strategies that drive the biomarker program forward
• Participate as a co-author for drafting relevant biomarker sections of clinical study protocol
• Work closely with Translational Molecular Biomarker (TMB) Scientist to manage specimen collection, handling, shipping, and storage guidelines that align with the Biomarker plan and clinical study protocol
• Accountable for providing biomarker vendor assay statement of work and data transfer specifications to the clinical teams
• Work with data management to effectively transfer biomarker data to clinical data repository from external biomarker vendors
• Work with Clinical team and/or Central labs to design sample collection kits, laboratory manual, and specimen logistics for shipments to third party vendors
• Maintain and grow effective partnerships with external biomarker vendors and our Company's internal teams
• Coordinate sample and assay logistics and serve as a key point of contact with vendors/collaborators for timeline tracking, issue resolution as a key point of contact with vendors/collaborators for timeline tracking, issue resolution and risk mitigation.

Skills and Knowledge:

• Well organized and methodical approach to problem solving
• Ability to understand and resolve conflicting needs of key stakeholders
• Proactively identify and resolve and/or escalate study-related issues
• Participate in process improvement initiatives or improving efficiency as needed
• Good understanding of clinical drug development process, GxP and ICH

Education:

• Bachelor's in a scientific or technological field of study with five (5) years of relevant experience
• Master's or higher degree in a scientific or technological field of study with three (3) years of relevant experience

Required Experience and Skills:

• Project Management experience within the Science realm (or relative realm)

Preferred Experience and Skills:

• Drug discovery experience, including familiarity with clinical trial execution in Oncology studies
• Biomarker assay experience including genomic/genetic, IHC, immunoassay, flow cytometry, mass spectrophotometry, and others
• Formal Project Management certification or training

#EligibleforERP

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

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US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected salary range:

$111,400.00 - $175,300.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R281430