drjobs Scientific AVP Oncology Diagnostics

Scientific AVP Oncology Diagnostics

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1 Vacancy
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Job Location drjobs

Rahway, NJ - USA

Monthly Salary drjobs

$ 250800 - 394800

Vacancy

1 Vacancy

Job Description

Job Description

The Associate Vice President (AVP)/ Oncology Diagnostics will be responsible for leading the oncology diagnostics strategy bridging the continuum from Discovery Research through LateStage Clinical Development. The successful candidate will have an essential strategic and tactical role in overseeing the scientific direction of companion diagnostics (CDx). Specifically the Diagnostics Lead will develop and execute diagnostic strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements.

Most importantly the role requires overseeing CDx development ensuring timely delivery of CDx solutions for pharmaceutical registration and launch. This individual is expected to stay up to date regarding industry trends and diagnostic regulatory requirements.

Essential Job Requirements:

  • Develop endtoend diagnostic strategy in collaboration with key stakeholders and ensure alignment with clinical development strategies and timelines.

  • Interact early with Discovery to understand the predictive hypotheses to be tested for specific programs and develop assays to reflect these hypotheses. Collaborate with internal research capabilities or external vendors to develop a predictive assay if not already available.

  • Conceive and develop CDx strategies for clinical development programs and obtain endorsement from various governance bodies

  • Work with Regulatory Affairs to ensure that regulatory documents (e.g. IDEs PMAs etc. are delivered and communicate with health authorities when required.

  • Oversee the CDx development and ensure timely delivery of CDx solutions for pharmaceutical registration and launch.

  • Communicate updates to and seek feedback from crossfunctional stakeholders surrounding the progress of the CDx program.

  • Stay up to date with industry trends technology advancements and regulatory requirements for diagnostic assays.

  • Drive diagnostic product innovation and improvement through both inhouse R&D efforts and in collaboration with diagnostic partners.

  • Participate in other training supervisory and management activities as required by the company.

Education:

  • PhD required

  • MD or MD/PhD is a plus

Required Experience and Skills:

  • 10 years of industry experience in clinical biomarker testing and CDx development.

  • Deep understanding of scientific concepts clinical development processes clinical testing guidelines and the regulatory requirements for diagnostic products and CDx.

  • Ability to identify key information and make data driven decisions.

  • Ability to use critical and strategical thinking to handle complex or ambiguous situations.

  • Ability to articulate facts ideas and strategies in all communication formats.

  • Ability to set and manage stakeholder expectations ability to influence without authority.

  • Ability to work effectively in a matrixed environment ability to manage crossfunctional teams.

Travel: up to 25

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.

Expected US salary range:

$250800.00 $394800.00

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.

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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/17/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.


Required Experience:

Exec

Employment Type

Full-Time

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