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Job Description

Translational Molecular Biomarkers (TMB) is responsible for translating preclinical molecular biomarkers to clinical development across all therapeutic areas and all phases of clinical development at our company's Research laboratories. TMB laboratories leverage a diverse array of technologies to develop biomarker assays to help confirm engagement of therapeutic targets and understand mechanisms drug action and patient response.

The Molecular Pathology group within the TMB organization is seeking a highly motivated candidate to join our team. The individual will play a critical role in the development and validation of pathology assays that are deployed in support of clinical trials. The candidate for this Associate Principal Scientist position should have strong technical expertise in molecular biology and tissue biomarker assessment and should have a strong interest in lab-based pathology assay work. In addition, the successful candidate should have the desire to collaborate closely with out-sourcing partners on the scientific oversight of pathology assays that support our pipeline.

Key Responsibilities:

  • Lead the development and analytical validation of histopathology-based (e.g., immunohistochemistry, multiplex immunofluorescence, fluorescent in-situ hybridization) assays for all therapeutic areas and all phases of clinical development.
  • Assist in the transition of biomarker assays from Discovery Research to Clinical Development by providing technical guidance on fit-for-purpose assay validation.
  • Deploy histopathology-based assays at external vendors to support our company's clinical trials globally.
  • Efficiently troubleshoot issues with assays placed at external vendors.
  • Provide scientific oversight of clinical sample analysis at vendors to ensure quality data delivery.
  • Serve as a subject matter expert in tissue-based assay development and validation, collaborating with project teams, biomarker leaders, clinical operations, and regulatory affairs on the implementation of these assays in clinical trials.
  • Interface with scientists and physicians in early and late-stage clinical development to execute on biomarker strategies in clinical trials.
  • Write and review validation and bioanalytical assay final reports, publications, SOPSs, memos, etc.

Education Minimum Requirement: 

  • BA/MS/PhD in a life sciences discipline (Biochemistry, Immunology, Molecular Pathology, Cell Biology, etc.) or Chemistry

Required Experience and Skills:

  • BA/BS with at least 13 years of relevant post-degree work experience, MS with at least 8 years of relevant work experience, or PhD with at least 3 years of relevant work experience
  • A minimum of 5 years of direct experience in histopathology-based assay development and validation (immunohistochemistry, multiplex immunohistochemistry or in-situ hybridization)
  • A basic knowledge of morphology in histopathological samples.
  • Strong understanding of histopathology, and biomarker development
  • Strong interpersonal, verbal, and written communication skills along with ability to work independently.
  • Proven leadership skills and the ability to execute within a matrixed organization.

Preferred Experience and Skills:

  • Broad knowledge of drug development process and translational medicine
  • Previous hands-on work in clinical biomarker development or managing the implementation of biomarker assays in support of drug development.
  • Prior experience in the fields of oncology, immuno-oncology, and immunology.
  • Previous hands-on work on acquisition and analysis of singleplex/multiplex IHC/IF images and single cell level high-dimensional data generation/analysis
  • Knowledge of using statistical software packages (i.e., Prism, SPSS).
  • Prior experience working in a regulated laboratory setting (e.g., CAP/CLIA).
  • Multiplex tissue-based spatial profiling assays (i.e., multiplex immunofluorescence, multiplex chromogenic Immunohistochemistry, imaging mass cytometry)
  • Image acquisition platforms (i.e., Leica Aperio, Hamamatsu, Pannoramic)
  • Commercial or open-source image analysis software packages (i.e., Visiopharm, HALO, QuPath)

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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

#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.

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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:

$122,800.00 - $193,300.00

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

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Confirmed 23 hours ago. Posted a day ago.

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