Executive Director, Translational Molecular Biomarkers Head

Job Description

Job Description

Attention NJ Applicants: In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.

Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate a compound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.

We are currently recruiting for a key individual to lead Translational Molecular Biomarkers (TMB). This critical role leads the Translational Molecular Biomarkers organization, which is comprised of 5 specialty laboratories (genomics, molecular pathology, flow cytometry, immunoassays, and mass spectroscopy), a biomarker leads organization, and a laboratory/logistics operations group. The leader provides strategic planning for determination of the mission and direction of the TMB organization by overseeing assay development, validation, and deployment for global phase 1-3 clinical trials across all therapeutic areas in a GxP environment.

This New Jersey-based Executive Director reports to the Vice President of Translational Medicine and sits on the leadership team. This leader must have scientific excellence in the field of laboratory chemistry, leadership, recruitment, and management skills to direct a group of 30 individuals, and excellent communication and collaboration skills. This individual will have a critical strategic and tactical role in overseeing the scientific direction of biomarker programs involving immuno-oncology, molecular oncology, immunology, neuroscience, cardiometabolic, and ID/vaccine programs.

The Executive Director will be expected to operate in a highly collaborative and matrixed environment, partnering with peers on site and at other locations in New Jersey, Pennsylvania and globally. This position will also require leadership to deepen and expand an already extensive network of external vendors.

The candidate will be expected to understand our company's portfolio, and collaborate with discovery biologists and clinical scientists to envision meaningful target engagement, pharmacodynamic, and patient stratification biomarkers with potential line-of-site to companion diagnostics. The candidate will be a part of the Diagnostics Leadership Team, to help develop biomarkers that may be developed for clinical use.

Primary Responsibilities:

• Oversee the development, performance, and monitoring of Quality Control, Quality Assurance and Quality Improvement procedures.
• Review and approve validation reports, final reports and other pertinent GxP documents using electronic and validated document repository systems.
• Review and create SOPs. Ensure their implementation in the GxP setting and ensure personnel training.
• Extensive knowledge of GxP, CLIA, CAP guidelines and regulations.
• Familiar with China-specific requirements.
• Experience in validation of clinical instruments, LIMS and electronic document and data repositories in compliance with GxP guidelines.
• Experience in the development and deployment of CDx, including familiarity with regulatory and commercial strategies.
• Oversee the generation and transfer of clinical data for our company's clinical trials according to corresponding guidelines.
• Serve as a subject matter expert in exploratory biomarkers and clinical biomarkers (CAP/CLIA) for our company's clinical trials.
• Design, deliver, and enable the execution of molecular biomarker strategies to drive pipeline and clinical development decisions across therapeutic areas outside Oncology.
• Oversee a team of TA biomarker leads and integrate them into key workstreams/teams to ensure timely biomarker planning and delivery aligned with pipeline development milestones
• Fully align with functional area (outside Oncology) stakeholders on the design and development of clearly articulated biomarker strategies that are shared, and actionable for pipeline decision making
• Simplify, prioritize, and/or accelerate critical molecular biomarkers to enable dose selection, patient stratification, GNG decisions
• Collaborate on the identification of novel and tractable biomarkers, and fit-for-purpose technologies
• Provide timely biomarker assay and biomarker data for all therapeutic areas
• Ensure TMB is fully aligned with Oncology Biomarkers and Biomarkers Operations.
• Ensure TMB is fully aligned with TMed TA leads, Discovery TA leads and other key stakeholders.
• Interface with CROs and external laboratories for the transfer, validation, and implementation of Flow Cytometry assays.
• Stay up to date of new technologies/methodologies/test and recommend implementation of new technology within the laboratory.
• Budget planning and adherence, payment of invoices, generation of Statement of Works (SOW) and POs for assay validations, etc.
• Oversee day-to-day TMB Laboratory work performance to determine staff resource utilization, effective management of workload, equipment maintenance.
• Provide key support to the Business Development-Enabling Technologies

Education:

A minimum of a PhD Degree (with at least 10+ years' experience) in laboratory medicine across assay multiple modalities.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are ...

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.

For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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US and Puerto Rico Residents Only:

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R185567