Merck Discovery Toxicology Program Leader in South San Francisco, California

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.

Merck Research Laboratories South San Francisco, a wholly owned subsidiary of Merck and Co., is focused on driving discovery research. Our new multi-disciplinary discovery research site offers state-of- the-art resources to explore the most promising science combined with Merck’s world-class R&D expertise in small molecules and biologics. Located within the heart of the Bay area’s biomedical community, research conducted in our new laboratories spans exploratory biology through early clinical development and is an integral part of Merck’s powerful world-class network of drug and vaccine discovery.

At Merck, we are inspired by the belief that a research-driven enterprise dedicated to scientific excellence can create medicines and vaccines that save and improve lives. Every employee is building on our proud legacy of scientific breakthrough. Our ability to impact the lives of patients worldwide depends on the integrity, creativity, humility and scientific acumen of our team. We are creating a diverse organization that is inspired by invention and founded on a culture of respect and collaboration. At Merck Research Labs South San Francisco, you’ll have the opportunity to expand your knowledge and skills through collaboration with talented and dedicated colleagues while advancing your career.

Merck is seeking an experienced Discovery Program Leader (DPL) at the South San Francisco, CA site 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 to the SALAR Preclinical Development organization located in West Point, PA. 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 world wide marketing authorization. The encubant is also encourage to develop an external-to-Merck presence acting as a member of pharmaceutical industry consortia and/or external scientific or professional organizations as appropriate.

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.

• Define the appropriate in silico, in vitro and in vivo studies, including the design, dose selection, and timing to help innovate and select candidates with the highest probability of success, and collaborate with SALAR and discovery scientists to assure the appropriate conduct of these studies.

• Effectively communicate the safety de-risking strategies, study data and conclusions to discovery teams, governance committees, and management.

• Collaborate with the discovery and SALAR scientists to address other scientific issues including assessment of efficacy, metabolism, formulation and purity of drug product and substance.

• Work closely with the SALAR development compound leaders and therapeutic area leaders to align on development plans, to facilitate a smooth transition of discovery programs into development and to assure the highest probability of success for the initiation of first-into-man studies.

• Provide due diligence support for licensing efforts of targets and candidates.

• Contribute to the planning and implementation of exploratory and mechanistic studies supporting discovery teams

PhD, DVM or MD degree

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:

  • 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.

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 staffingaadar@merck.com .

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Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Job Preclinical Dev Generic

Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Title: Discovery Toxicology Program Leader

Primary Location: NA-US-CA-South San Francisco

Requisition ID: PRE000647