Job Information
Merck Executive Director, Late-Stage Vaccine Clinical Development in Lower Gwynedd, Pennsylvania
Job Description
The Executive Director, Late-Stage Vaccine Clinical Development-Project AdVAnce will lead the Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Reg BA Late Stage Vaccine Clinical Development team with overall responsibility for method development, validation, and implementation of immunogenicity/ molecular biological assays as primary endpoint and/or safety assays for Vaccine development, focusing on Phase 3 clinical studies, and post-marketing studies.
Primary Responsibilities:
Conduct bioanalytical work to a high level of quality and rigor, ensuring compliance with regulatory guidance and for preparation of high-quality regulatory submissions.
Provide strategic direction and leadership for staff, builds strong teams, and attracts and develops diverse staff.
Provide technical oversight of the development and implementation of high-end robotics and data analysis tools for immunogenicity and molecular biology assays.
Education:
MS or Ph.D., in Biochemistry, Molecular Biology, Microbiology, Analytical Chemistry or a related discipline with a minimum of 15 years of bioanalytical or related experience, including Bioanalytical assay development and/or application of bioanalytical assays for clinical testing, in vaccine development.
Required Experience and Skills:
Demonstrated expertise in immunogenicity, molecular biology, method development, clinical assays, and analysis of biologics and vaccines is very desirable, together with excellent knowledge of how this information is used in clinical development.
Responsible for conducting bioanalytical work to a high level of quality and rigor to enable key development decisions, ensuring compliance with regulatory requirements/guidelines related to BA immunogenicity data, and for preparation of high-quality regulatory submissions
Experience in interactions with regulatory agencies is required, with a demonstration of successful bioanalytical strategies in Phase 3 testing and onsite health authority inspections.
Demonstrated leadership and management experience in the area of regulated bioanalytics, robotics, Laboratory Data Informatic Systems
A track record of sustained external visibility, through publications, presentations and/or involvement in professional organizations
Ability to set and deliver on current and future strategies
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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”.
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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:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/21/2024
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Requisition ID: R326579