Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
The Safety Assessment and Laboratory Animal Resources (SALAR) organization at West Point, PA, is currently seeking a highly motivated Developmental and Reproductive Toxicology (DART) Study Director to work closely with members of a collaborative team who design and oversee the conduct of in vivo DART studies supporting drug discovery and development programs. The candidate will also actively engage in core activities within the SALAR organization.
Key responsibilities include, but are not limited to, the following:
- Serve as the single point of control on assigned DART studies. Interact with technical and scientific staff to ensure that the study is in compliance with the protocol, Standard Operating Procedures, regulations, safety guidelines, and company policies and procedures
- Critically interpret and report results for regulatory submissions within established timelines. Integrate DART, toxicokinetic, and/or histopathologic data in performing risk assessments.
- Identify and resolve scientific issues
- Provide leadership for DART scientific projects and teams
Education Minimum Requirement:
- PhD degree in Developmental and Reproductive Toxicology or related discipline
Required Experience and Skills**:
- Postdoctoral fellowship and 0-2 years of experience as a DART Study Director OR at least 2 years of experience with DART and GLP.
- Understanding of Good Laboratory Practices (US FDA 21 CFR Part 58)
- Demonstrated ability to communicate clearly using verbal and written formats
- Proficiency with software used for data analysis and reporting
- Enthusiasm for developing/continuing to develop as a Developmental and Reproductive Toxicologist and for gaining experience in the drug development process
Preferred Experience and Skills:
- Experience with fetal morphology assessments (e.g., external, visceral, skeletal)
- Experience with electronic data capture systems for DART studies
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life.
If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Job: Preclinical Dev Generic
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable):
Company Trade Name: Merck