Pharma Project Director (Animal Health):
Merck

RES002051-en_US
Merck
Madison New Jersey
Pharmaceutical
Description
Requisition ID: RES002051

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.


The Director, Project Management will lead global multifunctional project teams to drive the development and registration of animal pharmaceutical (small molecules) products for MSD 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 and within budget.


The Global 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 execute 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 MSD Animal Health.


Responsibilities include:

  • Makes decisions or provides appropriate information for upper management decisions, 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.
  • 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 Schwabenheim Germany or Madison NJ and will report to the Associate Vice President of Pharmaceutical Development.


Qualifications

Education:  

  • Qualified candidates will have a Ph.D. in Animal Science or a DVM with 10+ years of industry experience in Pharmaceutical Drug Development or a related discipline.

Required:  

  • Qualified candidates must have exceptional technical and project management skills and a demonstrated track record of successfully leading the development of pharmaceuticals for animal (or human) health.  
  • The position requires high energy, team building skills, strategic thinking, judgement, and an ability to anticipate and address potential technical/regulatory/compliance issues. 
  • The candidate should have a focus on scientific excellence and the needs of customers.  
  • Experience should include authoring documents for regulatory submission and in constructing strategies to address complex technical and regulatory issues.  
  • Prior project leadership and/or supervisory experience is required.  
  • The candidate should have experience in direct negotiations with the US FDA and other worldwide health authorities to drive product approvals.

Preferred: 

  • The ideal candidate will have a personal drive for results and an ability to motivate other team members to deliver on project objectives.  
  • The candidate should have strong oral and written communication skills, with an ability to effectively communicate to various functional groups in the organization and external regulatory authorities.  
  • An ability to work independently, is highly organized, and can effectively multitask and prioritize is important in this role.  
  • Attention to detail, customer oriented, 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. 

 

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.

  

Search Firm Representatives Please Read Carefully: 

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.

 

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

 

            EEOC Poster

            EEOC GINA Supplement 


MAH2018



Job: Resch Science Proj/Prog Mgmnt
Other Locations:
Employee Status: Regular
Travel: Yes, 20 % of the Time
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Company Trade Name: Merck
Basic Qualifications
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