Job Description

Job Description

Clinical Imaging Scientist with a team-first spirit to oversee the collection, analysis, and reporting of safety and efficacy data in clinical trials that is based on clinical imaging assessments.

Primary Responsibilities include:

Supporting clinical trial teams in using scientifically and operationally appropriate analyses of clinical imaging to assess efficacy and safety endpoints in clinical trials for regulatory submissions and internal decisions:

* Support development of the imaging section of clinical trial protocols to ensure that they follow established standards and that the assessments support the trial endpoints

* Develop/present training slides on imaging assessment for a trial for internal company personnel and/or for trial site staff

* Apply Good Clinical Practice and ability to provide support to clinical teams on imaging-related issues such as radiation exposure and informed consent language

* Provide technical support for regulatory filings that may include preparing written responses, developing storyboards, and presenting in support of inspections

* Provide input on site data collection methods, forms, and site monitoring

Managing the use of independent central review in trials supported by an imaging vendor:

* Lead the development and approval of the imaging requirements to clearly define the scope of work requested by clinical team. Consider specific needs of trial, the experience of iCROs, and budgets provided to make recommendations on iCRO selection

* Manage the development and approval of vendor-generated materials including Imaging Review Charters, Site Imaging Manuals, and other documents. This entails providing guidance to and seeking input from our company stakeholders including statistics, clinical science, study management, data management, quality, and regulatory

* Coordinate the development and approval of other documents, processes, and decisions to be implemented by the iCRO; this includes reviewer selection and training, data capture system functions, data transfer specifications, reader performance monitoring plans and metrics

* Guide collaboration between the clinical trial team and the vendor, providing scientific and operational input during startup activities and during the execution of the trial, as needed

* Collaborate with vendor management, procurement, and Imaging Lead to support governance of iCROs

* Work with compliance team to support audits and/or review audit findings of iCROs

Contributing to research, education, and process improvement:

* Promote a learning culture by educating other company teams on the role and proper use of imaging in drug development

* Promote the development of a translational research culture by consulting with Imaging Leads regarding imaging technology development, deployment, and application

* When appropriate, participate in the scientific development of novel approaches to image analysis and the use of imaging in trials

* Lead process improvement initiatives to optimize team functioning, communication with other stakeholders, interactions with vendors, and other aspects of the teams work

Minimum Education & Experience Requirements:

* Bachelor's degree with a minimum of fourteen (14) years of clinical imaging and/or drug development experience

* Master's degree with a minimum of ten (10) years of clinical imaging and/or drug development experience

Required Experience:

* Experience working with or for an imaging CRO in support of late-stage clinical trials

* Knowledge of multiple imaging modalities and their application to drug development

* Knowledge of clinical trial design incorporating imaging biomarkers for evaluation of efficacy and safety

* Skill in authoring clinical imaging operations documents for studies using imaging evaluation of efficacy and safety

* Highly developed time management skills with a track record of managing complex projects with minimal supervision

* Excellent communication skills, with a demonstrated ability to effectively collaborate with culturally diverse stakeholders

Preferred Experience:

* A minimum of five (5) years of experience supporting clinical drug development in an industry setting; oncology is strongly preferred

* Trained and certified as a radiologic technologist with experience working in a hospital setting

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., Kenilworth, 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

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

Not Indicated

Valid Driving License:

Hazardous Material(s):

No

Number of Openings:

1
Requisition ID:R88887