Executive Director CMC PCV Franchise:
Merck

REG003562-en_US
Merck
West Point Pennsylvania
Pharmaceutical
Description
Requisition ID: REG003562

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. 

 
Reporting to the Head of Global Regulatory Affairs and Clinical Safety (GRACS ) Vaccines CMC, the Executive Director will provide regulatory leadership, oversight and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions for vaccines.  This includes preparation of applicable sections of clinical applications (IND and IMPD), Agency Background Packages, Worldwide Marketing  Applications, and responses to Agency questions for global markets.
 
The primary focus of the position is providing direction to team leaders and members that are responsible for developing and executing regulatory strategies and making decisions that ensure the high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes during various phases of development, defining regulatory requirements, developing CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business, utilizing regulatory intelligence and incorporating knowledge of the changing regulatory environment.  This individual will be a key, senior member of the Vaccines CMC leadership team supporting the department in all relevant areas of expertise. 
 
In particular, this individual will oversee the continued rapid growth of the CMC teams supporting each of Merck’s pneumococcal conjugate vaccine programs.  This individual will be responsible to hire, mentor and coach the PCV team leads and members in support of all stages of development and commercialization.  This individual will be responsible for the development and maintenance of an overarching strategy relating to rapid initial licensure of the first PCV vaccine candidate and the successful transitions to each new generation PCV vaccine.   
 
This individual will oversee all PCV program elements including:
  •  Manage and develop the PCV team leads and members assuring that the teams provide expert regulatory support to each program
  • Work closely with stakeholders to develop processes and clarify roles and responsibilities to assure timely strategy and dossier development
  • Assure the development and maintenance of IND and BLA templates and TOC’s suitable for efficient use by the PCV authoring community
  • Develop programs to educate and increase expertise across the PCV CMC teams  
  • Collaborate with the Reg. Liaison Lead for PCV programs in providing appropriate strategy and governance for the global regulatory teams  
  • Assure that the PCV teams utilize all elements and resources of the CMC operating model, taking advantage of Site CMC, iCMC, Device CMC and the CMC program office to support timely, well-coordinated submissions and approvals of the PCV programs worldwide.
     
    Responsibilities:
  •  Accountable for proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner
  • Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges
  • Drive application of regulatory strategies and concepts across multiple disciplines and multiple organizations, including working directly with Senior Leadership in MMD and MRL in these areas
  • Embody the Merck Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently
  •  Continuously evaluate and develop talent within the team and prepare a succession plan
  • Use recognition and rewards to promote team and organizational collaboration 
  • Set a vision for the team and hold employees accountable for execution of departmental policies and procedures
  • Flexibly manage and allocate resources to support execution and delivery of prioritized work to meet business commitments
  • Actively sponsor employees who lead and participate in Merck initiatives 
  • Cultivate and foster strong collaborative relationships with stakeholders and partners across the organization
  • Represent the department’s needs and positions in senior leadership forums
Qualifications

Skills:
  • Develop and maintain expert knowledge of current global regulatory CMC requirements for investigational submissions, original registrations and post-approval changes. This includes knowledge of the regulatory guidance for bacterial polysaccharide conjugate vaccines.
  • Identify and resolve technical and operational problems associated with regulatory strategy and submissions using rapid, disciplined decision making; collaborate with peers to resolve cross-functional obstacles using excellent critical thinking skills. 
  • Look for innovative and scientifically sound approaches to gain approval.
  • Participate in the development of CMC business processes or organizational initiatives as needed. 
  • Lead the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of submissions. 
  • Develop and maintain an expert knowledge of Industry Association Whitepapers, Health Authority regulations & guidance documents. Utilize expert knowledge and reputation to influence the content of new Industry Association Whitepapers, Health Authority guidance & regulations.  Present and participate at industry meetings.
 
 
Qualifications:
  • Degree in pharmacy, chemistry, engineering, biology or a related discipline.
  • Minimum 15 years pharmaceutical industry experience; or minimum 10 years industry experience with an advanced degree. 
  • Minimum 7 years working in Regulatory CMC, including the development stages of the product life cycle.
 
Preferred Experience and Skills:  
  • Strong experience in Regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, and quality assurance)
  • Experience managing a team of Regulatory CMC professionals
  • Strong experience in vaccines pre/post approval expertise is highly preferred
  • Demonstrated ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events
  • Demonstrated depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities
  • Excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts
  • Demonstrated experience in building, rewarding and retaining key talent
  • Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data 
  • Proficient in English; additional language skills are a plus

 

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 



Job: Regulatory Affairs - CMC
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Employee Status: Regular
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Company Trade Name: Merck
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