Requisition ID: RES002253
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's Animal Health (MAH) Division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and planet. This team of energetic, independent thinkers offers one of the industry's most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.
The Director Project Management will lead global multifunctional project teams to drive the development and registration of new animal pharmaceutical products for MERCK Animal Health (MAH) R&D. In this critical role, the Director is responsible for all aspects of pharmaceutical product development and will lead cross-funcional teams to achieve the project plan on schedule, on target and within budget.
The Global Drug Discovery & Pharmaceutical Development Department drives the progression of pharmaceutical drug candidates from discovery through development to commercialization. As a global project leader of this department, the Director will develop and exectute strategies for drug development programs and ensure the required data for regulatory approval and commercial value are generated. Hence, this is a high-visibility project leadership position with the potential for significant impact on the future success of MERCK Animal Health.
Accountable for making project-related decisions or recommendations, guided by the R&D plan, that impact project approval timelines and thus the ability to achieve MAH financial objectives. This requires familiarity with regulatory requirements for veterinary products, especially in the US and EU, and skills necessary to negotiate with the US FDA and other worldwide regulatory authorities in order to achieve successful product registration and commercialization on a timely basis.
Lead projects for new chemical entities in a diverse portfolio of novel anti-infectives, parasiticides, or internal medicine candidates, e.g. dermatitis, diabetes, oncology, ophthalmology or reproduction.
Directs and manages all project team activities to resolve technical issues and to ensure all project goals and timelines are achieved. This is accomplished by interacting with key stakeholders across divisions and influencing others internally and externally to complete their assigned tasks on schedule.
Takes a leadership role and acts as a facilitator and mentor to empower others during execution of the R&D project plan, has overall accountability for assigned projects, and communicates progress to MAH stakeholders.
Modifies project plans to address any technical / regulatory concerns and accurately reports and keeps current the MAH Project Management database.
Prepares and reviews study protocols and final reports to ensure alignment with project objectives, consistency with applicable regulations, and alignment with MAH policies.
Collaborates with Manufacturing to resolve any rate-limiting issues to ensure product availability during product development and launch.
Collaborates with Marketing to establish accurate market assumptions and sales estimates for new proposed projects.
Collaborates with Technical Service to develop product introduction strategy and assists during launch and post launch product defense activities.
Manages each project's budget; establishes yearly project budget, tracks expenses, and updates the R&D external budget report.
Develops innovative technologies, processes, new products, and claims that address current and future customer problems or needs.
Develops new project proposals and presents recommendations to others in company. Prepares invention disclosures and assists during the creation and review of patent applications.
This position will be based in Madison, NJ and will report to the Associate Vice President and Global Head of Drug Discovery & Pharmaceutical Development.
Education Minimum Requirement:
Qualified candidates will have a DVM and/or a Ph.D. in life sciences.
Qualified candidates must have at least 8 years experience in project management in the area of pharmaceutical development. The position requires a high energy level, team building skills, strategic thinking, judgement, and an ability to anticipate and address potential technical/regulatory/compliance issues.
Strong oral and written communication skills with an ability to effectively communicate to various functional groups in the organization and external regulatory authorities are critical. Strong business acumen. The candidate should have a focus on scientific excellence and the needs of customers.
The ideal candidate will have a personal drive for results and an ability to motivate other team members to deliver on project objectives. The ideal candidate has an ability to work independently, is highly organized, and can effectively multitask and prioritize. Attention to detail and focus on continuous improvement are also important traits for this role.
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.
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Visa sponsorship is not available for this position.
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Job: Resch Science Proj/Prog Mgmnt
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): N/A
Company Trade Name: Merck
Nearest Major Market: New Jersey
Merck & Co., Inc.