Sr. Principal Scientist - Preclinical Safety
We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
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.
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 Development organization located at our West Point, PA site. 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 Cardio-renal and Metabolic Disease Area but also Ophthalmic and Oncology Disease 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, or MD degree 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 immunology and immuno-oncolgy 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.
- Expertise in cardio-metabolic and oncology disease areas.
- 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.
If you need an accommodation for the application process please email us at firstname.lastname@example.org
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We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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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.
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