Shire Jobs

Job Description

Job Description:

Our Biomarker Operations team is seeking a Senior Scientist in Biomarker Policy to manage biomarker samples and ensure compliant utilization of clinical participant biospecimens to answer scientific questions across our company's pipeline.

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 sample collection and disposition. Your work will also focus on biomarker specimen management and compliance, ensuring appropriate planning and execution of specimen transfers, destructions, and study close-out activities. These activities will follow internal policies and standard operating procedures to ensure compliant specimen handling. The position will partner closely with our company's biomarker operations roles, clinical teams, vendors, and several other company departments.

Major activities and responsibilities:

• Ensure Operation teams are executing biomarker research within Biomarker Policy requirements, maintaining compliant usage of consented samples

• Liaise with scientists, vendor management and project managers on efficient execution of biomarker research and continuous process improvement

• Provide oversight of contractors responsible for consent and specimen management for biomarker specimens collected in clinical trials

• Support Global Clinical Development processes

• Utilize internal specimen inventory management systems to support activities including compliant oversight of clinical specimens for future use requests, destructions, returns for on-going care, and specimen consolidation/transfers

• Support the development and implementation of job aids and other process documents

• Point of contact for biomarker clinical specimen management related questions and issues from both internal and external stakeholders

Qualifications

Education Minimum Requirement:

• BA/BS in a scientific or technological field of study

Required Experience and Skills:

• For BA/BS: ≥ 5 years related experience

• For MS/MA or higher degree: ≥ 3 years related experience

Preferred Experience and Skills:

• Sample Management experience, preferably with clinical trial specimens

• Informed consent authoring and/or review experience within a relevant biopharmaceutics industry

• Familiarity with clinical trial execution including drug discovery, early and late stage development

• Strong data and information system experience including Win10 tools

• Desire to work in a collaborative environment, excels at communication, presentation, and organizational skills

• Proven ability to simultaneously balance diverse activities for multiple projects.

• Strong analytical skills with attention to detail

• Strong project planning, problem solving and decision-making skills

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.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/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.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 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, Monday - 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:

$111,400.00 - $175,300.00

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 (https://www.benefitsatmerck.com/) .

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

12/4/2024

*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: R324709