Job Description

Biomarker Diagnostics Operations, Associate Principal Scientist, Clinical Research

We are currently seeking an Associate Principal Scientist to manage biomarker diagnostic projects in the Translational Medicine’s Biomarker Operations department. You will work closely with scientific and operational teams to deliver on biomarker and diagnostic objectives, encompassing clinical protocol set-up through assay data generation and filing. You will be responsible for the strategic and tactical operations of your projects. This position will report into the Leader of the Diagnostic Operations group within the Translational Medicine department and be based either at our Company's Pennsylvania, New Jersey, or Boson site.

You will have experience in biomarkers and diagnostics and demonstrated success in leading teams to deliver the highest quality science in a timely, efficient, and compliant manner. You will have strong influencing, negotiation and communication skills and be expected to operate in a highly collaborative and matrixed environment. You will excel under fast-paced and fluid conditions and be a strong leader of an operational excellence culture.

Primary job responsibilities include:

• Determine, design, communicate and track biomarker diagnostic logistics and planning needs for late-stage clinical trials: This involves assessing the requirements for biomarker implementation and execution and providing assay-related direction to operational teams for seamless integration of biomarker assays at vendors and our Company's labs

• Foster collaboration with biomarker and diagnostic partners: You will work closely with scientists, regulatory experts, and clinical and biomarker operations teams to ensure alignment of requirements and logistics across clinical trial protocols

• During the execution of clinical trials at vendors, you will work with vendors and internal stakeholders to actively identify, resolve, track and communicate any assay-related issues

• Work with data management in the collection and monitoring of biomarker diagnostic data, ensuring integrity and quality throughout the trial

• Collaborate with sample management groups for biomarker diagnostic research projects, ensuring compliance with relevant regulations and guidelines

• Be accountable for efficient project execution by ensuring deliverables and timelines are clear, resources are appropriately planned and managed, communications within and external to the team are effective, risk management plans are in place, issue resolution is productive, information is accurately tracked and accessible, and compliance is adhered to at every stage

• Contribute to filings and regulatory interactions as needed

• Work closely with other operational groups to provide a streamlined and cohesive approach encompassing vendor, project, and sample and information management of molecular biomarkers and diagnostics

• Identify, assess, and implement operational improvements as needed to enhance the efficiency and efficacy of the translational biomarkers and diagnostics

• Continually survey the internal and external environment for trends, risks, gaps and opportunities and ensure your teams meets new challenges and opportunities

Minimum education required:

• Bachelor’s in life sciences or related field and eight (8) years of relevant experience

• Master’s or higher degree in life sciences or related field and five (5) years of relevant experience

Required Experience and Skills:

• A minimum of five (5) years of drug discovery experience, including late-stage clinical trial experience

• Experience in biomarker and diagnostic development

Preferred Experience and Skills:

• Five (5) years of experience in a GCP/GLP or CAP/CLIA lab environment

• Formal Project Management certification or training

• Regulatory and filing experience

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

$135,500.00 - $213,400.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. 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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/14/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:09/14/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R308359