Executive Director, Oncology Job

Employer
Merck
Location
Rahway, NJ, US
Posted
September 15 2017
Organization Type
Pharma
Executive Director, Oncology-REG003145

Description

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.

The Executive Director, reporting to Associate Vice President, Global Regulatory Therapeutic Area, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in Oncology. The individual functions with a high degree of independence and provides oversight for assigned products, directly manages some liaisons. Recognized as an expert in oncology drug development and provides technical and professional leadership to staff handling multiple projects. Therapeutic Area expertise is leveraged internally to provide advice to staff and externally via committee representation and consultation. Recognized internal expert for one or more aspects of regulatory policy or geographic regions.

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Create and implement global regulatory strategy for oncology products to minimize time to approval.

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Oversight, management, and review of Liaisons including review of regulatory strategy for Liaison’s respective products as needed

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Review and provide final approval of WMA subsections;

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Review and approve communication materials to be used external to Merck such as press releases for accuracy and consistency of message; Review and approve final approval for background packages to ensure clarity and comprehensive presentation of issues.

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Provide review of labeling; Manage label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet

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Oversee regulatory due diligence activities for licensing candidate review

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Manage the liaison support process, including resourcing for project assignments, role definition and management of activities for specific products

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Provides technical and professional leadership to staff and conducts all appropriate HR activities such as managing performance, Development planning; staffing and related people-management responsibilities for liaisons within areas of responsibility.

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Represent Merck as needed at external initiatives notably with regulatory authorities

Qualifications

Education Requirement:

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Degree in biological science, chemistry or related discipline preferred.

Required:

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Regulatory experience required with preference for therapeutic area experience in Oncology

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M.D. with 7-12 years relevant drug development experience required preferably with 5 years in Regulatory

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PhD with 7-12 years relevant drug development experience required, preferably with 5 years in regulatory

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M.S. or B.S. with 12-15 years relevant drug development experience a majority of which was in Regulatory

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Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies is required.

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Outstanding interpersonal, communication and negotiation skills are required.

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Demonstrated leadership attributes; experienced at building and leading high performing teams; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.

Preferred:

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Experience with international regulatory authorities outside of USA, EU, JPN.

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Medical devices and in-vitro diagnostics.

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 an accommodation for the application process please email us at 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​



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


Job: Regulatory Affairs Liaison

Job Title:Exec. Dir, Regulatory Liaison

Primary Location: NA-US-NJ-Rahway

Employee Status: Regular

Number of Openings: 1

Company Trade Name:Merck