Associate Principal Scientist, Genomics Policy

18 Feb 2024
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Job DescriptionOur Biomarker Operations team is seeking an Associate Principal Scientist in Genomics Policy to help drive innovative biomarker research across the company's portfolio. The goal of the organization is to ensure compliant utilization of clinical participant biospecimens to answer scientific questions across the company's pipeline, with an emphasis on the Oncology pipeline and innovations to improve patients’ lives.This is an opportunity in the Genomic Policy and Biomarker Operations within the Translational Medicine Department in our company's Research Laboratories. In this important role, you will work collaboratively to ensure compliance of the protocol language and informed consent process, including, but not limited to clinical biomarkers, future use, and genetic/genomic sample collection, and disposition. You will also work directly with our consent specialists to successfully negotiate and document global and country permissions and updated regulations, provide subject matter expertise for informed consent process improvements, and work with Global Clinical Trial and Operations to maintain GCD standards, processes, and templates. Your role will enable the sample collections for biomarker research, including nimble sample retrieval and usage, and compliant processes with vendors and designated biorepositories. In addition to these core responsibilities, your role may also involve contributions in information management towards improvements in automation, workflows, and visualizations related to country regulations, sample management, and other workstreams.Primary job responsibilities include:

Collaborating with specialists to ensure informed consent negotiations, escalations, and facilitation of BMx, future use, and genetic sample collection and disposition

Leading the protocol and informed consent processes and templates for clinical trial biomarker and future research

Providing country operational support and lead process improvements, negotiating country issues, and documenting updated regulations

Ensuring Biomarker Operation teams are executing biomarker research within the documented requirements, maintaining compliant usage of consented samples

Improving visualizations and automation workflows for Genomics Policy and Biomarker Operations processes to enhance efficiencies and oversight

Liaising with vendor management, project managers, and companion diagnostic operations for efficient execution of biomarker research and synergies across operations

Working in collaboration with non-company contractors responsible for consent authoring, negotiations, and documentation of permissions for biomarker research to be conducted

Education:

Bachelor's in a scientific or technological field of study and eight (8) years of scientific related experience

Master's or higher degree in a scientific or technological field of study and five (5) years of scientific related experience

Required Experience and Skills:

Prior clinical trial experience

Preferred Experience and Skills:

Consent review experience within a biopharmaceutics industry

Genetic and/or Biomarker experience, including Next Generation Sequencing

Drug discovery experience, including familiarity with clinical trial execution

Data and information system experience including Win10 tools

Strong people leadership, communication, presentation and organizational skills

Excellent communication skills (both oral and written)

Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects

Strong scientific and analytical skills with attention to detail

Strong project planning and decision-making skills

#EligibleforERPEmployees 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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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:EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA Supplement​Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)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 (https://www.msdprivacy.com/us/en/CCPA-notice/)U.S. Hybrid Work ModelEffective 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 - $213,400.00Available 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 (https://www.benefitsatmerck.com/) .Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:1st - DayValid Driving License:NoHazardous Material(s):noRequisition ID: R281226

Full-time
  • ID: #51081296
  • State: New Jersey Rahway 07065 Rahway USA
  • City: Rahway
  • Salary: USD TBD TBD
  • Showed: 2024-02-18
  • Deadline: 2024-04-18
  • Category: Et cetera
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