Associate Principal Scientist, Drug Safety & Metabolism

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

Our Animal Health Research Laboratories team work tirelessly to invent solutions to improve the health and wellbeing of animals. Our state-of-the-art research facilities create an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges. 

We are seeking an experienced preclinical safety scientist to join the Global Preclinical Development team in Drug Safety and Metabolism.  This position is located in Madison, NJ and will be responsible for, or will assist with, human safety and target animal safety program strategy and execution for all phases of global veterinary pharmaceutical drug/product research and development and will provide support for marketed products. 

The ideal candidate will:

• Design, place, monitor, report, and resolve issues for outsourced in vitro and in vivo safety, toxicology, ADME studies utilizing external CROs and/or consultants, as applicable.  Toxicology and related ADME studies include most typical rodent and non-rodent species.  Target animal safety and target animal ADME studies may include companion animals (dogs, cats, horses) and production animals (cattle, pigs, chickens, sheep, goats, fish).
• Conduct literature searches and author expert reports, position papers or other strategic scientific / technical / medical assessments to address safety issues for products, drugs, excipients, chemical impurities, or other chemicals.
• Interact with regulatory agencies to address safety concerns with products in development or marketed products, including preparation/submission of documents and formal presentations. 
• Prepare human safety and target animal safety sections of product registration dossiers and product labels for submission to domestic and international regulatory agencies.
• Closely collaborate with Drug Safety and Metabolism colleagues to accomplish diverse preclinical objectives for projects and products.
• Pro-actively collaborate within global cross-functional project teams (e.g., clinical, pharmaceutical development, regulatory affairs, quality, manufacturing, etc.) in a matrix organization.
• Maintain technical and professional expertise by staying up to date with developments in the field and sharing that information within the company as appropriate. 

Education Minimum Requirement: 

• DVM and/or PhD in toxicology, pharmacology, or other relevant biomedical science discipline with at least three (3) years of experience in preclinical safety or equivalent combination of education, training, and relevant experience. or Masters Degree with at least five (5) years or Bachelor's Degree with at least seven (7) years of experience.

Required Experience and Skills: 

• Strong verbal and written communication skills are crucial for success in this position. 
• A team-player with excellent inter-personal skills and experience collaborating in a diverse global cross-functional team environment.
• Ability to work independently and self-manage assigned workload including diverse deliverables and timelines with competing priorities.
• Proficiency at placing, designing, monitoring, and reporting in vivo studies (e.g., toxicology, ADME) at CROs.
• Experience using in vitro and in vivo data and published data/literature to support drug and/or product development, registration and/or defense.
• Working knowledge of the Good Laboratory Practice (GLP) regulations.
• Proficiency with standard computer software applications for general office work (word processing, presentation, and spreadsheet).

Preferred Experience and Skills: 

• A working understanding of domestic and international veterinary drug/product development and various agribusiness practices affecting companion and production animals, including aquaculture.
• Proven experience in pharmaceutical drug development and with global regulatory submissions for companion and food animal drugs.
• Experience successfully authoring risk assessments / expert reports / scientific position papers for a non-expert audience.
• Experience as a GLP Study Director for in vivo toxicology studies.
• DABT certification.

Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals , we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

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

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.

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.

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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.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R140008