Sr. Principal Scientist – Preclinical Safety

Job Description

We are seeking an experienced Discovery Program Leader (DPL) to represent Safety Assessment & Laboratory Animal Resources (SALAR) on discovery research teams and represent SALAR in scientific and strategic review meetings with site and disease area management. The senior DPL is embedded with discovery teams and acts as a member of disease-area oversight committees and serves as the liaison back to the SALAR Preclinical Discovery and Development organization. Thus, this position requires exceptional leadership, collaboration, and independence and a passion to work collaboratively across functions and sites to discover novel medicines that improve the lives of patients.

The senior DPL is responsible for defining and overseeing the SALAR strategy for small molecule, peptide and biologics programs from Target Identification through to the approval of First-In-Human enabling GLP toxicity studies. They are responsible for 1) providing risk assessments for targets, 2) de-risking strategies for programs as members of discovery teams and 3) instructing SALAR staff at other sites to execute on the appropriate studies to support selection of therapeutic targets and the identification and development of new drug candidates with the highest probability of success for the intended indication. The DPL may also serve on development teams with responsibility for defining the GLP toxicology study strategy and execution, and for the non-clinical safety sections of regulatory documents that support clinical trials and worldwide marketing authorization.

In this role you will:

• Represent SALAR on discovery teams and participate in therapeutic area discovery governance committee reviews.

• Promote and facilitate creative thinking from target identification/validation through lead optimization towards advancing programs primarily in the Oncology, Immunology & Neuroscience Therapeutic Areas.

• Be a “drug creator” and promoter of innovative thinking by influencing both cross-site disease area aligned groups as well as functional area disciplines.

• Be responsible for contributing to disease area strategy in collaboration with senior management and play a lead scientist role on Scientific Review committees.

• The individual may also lead early development teams, informing on preclinical studies to support product development.

• Identify and assess potential risks associated with therapeutic targets or development candidates using available literature, internal data, and external information.

Education Minimum Requirement:

• PhD in relevant field, DVM, MD degree or equivalent is required.

Required Experience and Skills:

• Minimum 10+ years of demonstrated pharmaceutical industry experience as a non-clinical safety scientist (e.g. Toxicology, Pathology etc.) and/or as non-clinical safety assessment representative to a cross-functional development and/or discovery teams.

• Demonstrated ability to successfully navigate cross-functional lines and drive team decision making in a matrix organizational structure.

• Highly dedicated, motivated, resilient and flexible; capable of creative problem solving and delivering on goals and objectives in a timely fashion in a scientific business model setting.

• Excellent team player who is able to work collaboratively with discovery team members from various functions, other SALAR DPLs and SALAR scientist responsible for study conduct and portfolio management in the development space towards common objectives.

• Excellent interpersonal skills and able to establish good working relationships within networks of employees of all levels and personalities fostering cooperation in others.

• Excellent communicator who know when and how to speak up and appropriately raise issues to appropriated stakeholders and to management; keeps both team members, colleagues and management full apprise of project/initiative status and issues.

Preferred Experience and Skills:

• Background and experience in oncology, immunology or neuroscience is preferred.

• Experience with biopharmaceuticals and small molecules pharmaceutical development and/or discovery.

• Experience in problem solving for non-clinical toxicological issues and developing assays to “de-risk” compounds.

• Experience with regulatory submissions and responses.

• Experience as the non-clinical safety expert on governance, review or oversight committees in the pharmaceutical industry.

• Experience as member of pharmaceutical consortia and/or external scientific or professional organizations.

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., 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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

Invent. Impact. Inspire.

NOTICE FOR INTERNAL APPLICANTS

In accordance with [Register to View] 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.

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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.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Valid Driving License:

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Requisition ID:R121532