Principal Scientist, Toxicology

Our Company's Research Laboratories, a leader in the pharmaceutical industry in discovering and developing new drugs, is searching for a Toxicologist (Principal Scientist) with a background or interest in ophthalmology to conduct toxicity studies (GLP and non-GLP) as a Study Director and to conduct nonclinical ophthalmic examinations. The nonclinical Toxicology group within Nonclinical Drug Safety (NDS) at our Research & Development Division in West Point, PA evaluates the toxicity profile of compounds using in vitro and in vivo studies.

Toxicologists at our Company serve as Study Directors and are integral members and leaders of collaborative cross functional scientific teams, addressing challenges from early discovery to late development. Our Company's Toxicologists provide scientific leadership in the design and overall conduct of in vivo studies and integrate the findings from all contributing scientists into reports that characterize the safety profile of drug candidates.

Key Responsibilities

• Conduct acute to chronic toxicology studies, including the in-life phase, from protocol development, through data interpretation, to report authoring.

• Conduct ophthalmic examinations on a variety of nonclinical animal species, interpret data, prepare reports, and serve as a resource within the Company in ophthalmology. Training, as needed, in ophthalmic examinations would be provided.

• Serve as the single point of control (Study Director) on assigned general toxicology studies. Interact with technical, veterinary, and scientific staff to ensure that the study is in compliance with the protocol, amendments, Standard Operating Procedures, regulations, safety guidelines, and company policies and procedures.

• Critically analyze data, interpret data, and communicate results within established timelines. Integrate data from other areas (ECG, ophthalmic, pathology, toxicokinetics, clinical pathology) in written reports used for regulatory submissions.

• Communicate with study and drug development staff on findings and participate on cross-functional teams to elucidate mechanisms of toxicity, utilizing additional tools and applications that are all available on-site.

• Our Company's toxicology study directors potentially also serve as nonclinical safety assessment leads on drug development teams, overseeing the design and conduct of studies, and generation of regulatory strategies and communications with global regulatory agencies to support the development of drug candidates.

Education

• PhD in toxicology, pharmacology, or related scientific discipline.

Requirements

• Minimum of 5 (five) years of relevant experience as a regulatory toxicologist or study director in biotech, pharma or at a CRO after Ph.D.

• Demonstrated understanding of and experience with Good Laboratory Practices (US FDA 21 CFR Part 58).

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Strong interest in collaborating with diverse cross-functional teams and communicate openly and often with colleagues.

• Ability to communicate clearly using verbal and written formats.

Preferred

• Expertise in Ophthalmic examinations or expertise/knowledge in ophthalmology (e.g., anatomy, pharmacology, or toxicology).

• Background in veterinary medicine or experience working with laboratory animals.

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.

Residents of Colorado

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Residents of Colorado:

Click here to request this role's pay range.

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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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Work Week

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):