Executive Director, Regulatory Affairs Oncology Colloborations & Early Programs Job

Executive Director, Regulatory Affairs Oncology Colloborations & Early Programs-REG002636

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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


This position is a newly created role within the Global Regulatory Oncology Therapeutic Area to lead the strategy that has been identified to support our expanding oncology portfolio demands.

This role will be comprised of two distinct branches:

1) Oversight and Leadership of the External Collaborations

2) Oversight and Leadership for the Early Development Programs through (Fist in Human - FIH) at Merck.

1. Collaborations - Joint development agreements (either early or late stage) with Merck Oncology products and external Partner projects.

- Facilitates and leads in collaboration with the Regulatory Therapeutic Area (TA) liaison and Global Regulatory Affairs and Clinical Safety (GRACS) Licensing, in the evaluation, development, and execution of strategies for externally partnered projects.

- Define needed internal expertise by coordinating within GRACS on appropriate representation for external joint teams, and prepare for Merck-decision making

- Design development plan with joint teams according to governance-agreed strategies

- Responsible for, and may lead efforts to provide input into disease strategy development, clinical program assumptions, regulatory strategies, and companion diagnostic strategies

- Engage with RAE or RAI, as needed, to ensure comprehensive global regulatory feedback on the collaboration project

- Serves as the key Regulatory point of primary contact for Alliance Management, Global Commercial, Business Development and Legal to ensure early input of regulatory strategy as projects are evaluated for internal development or collaboration

- Collaborate with respective Global Regulatory Leaders (GRL’s) to ensure that joint development agreements/contracts address critical regulatory details to satisfy and address in sufficient detail the full spectrum of regulatory activities (development, regional MAA submissions, impact to Merck product labeling, lifecycle etc.) Represent or ensure the best representation for regulatory membership on a Joint Development Committee until the appropriate indication lead has been identified and can ensure smooth transition to the respective GRL

- Understand, communicate and provide executive leadership with assessment of collaboration strategy and regulatory implications

2. Early Development Programs (Pre-IND to Proof of Concept/FIH)

- Serves as the initial single point of contact for the Early Development Committee for regulatory considerations of the early portfolio

- Collaborate with EDC lead and co-lead to evaluate strategy and new potential opportunities

- Ensures the appropriate transition of regulatory activities to relevant GRL, based on work load and internal expertise, to continue providing strategic and project support for any new or existing IND/CTA

- Provide an updated and balanced appraisal of the project status, including risk, cost, and value to stakeholders, as needed

This role will sit on the TA leadership team and will contribute on the across all aspects of product development, across the portfolio, will ensure the appropriate GRLs are aware of new collaborations and potential implications of registration activities reflective of the partnership contract. This role will require management and development of a minimum of 1-3 individuals.

The individual will also represent Merck for assigned regulatory policy initiatives partnering closely with the GRACS policy team and other SME’s as appropriate.

Qualifications

Education:

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M.S. or B.S. with a minimum of (12) years relevant Drug Development experience, with a majority of which was in Regulatory

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M.D. or PhD with a minimum of (7) years relevant Drug Development experience preferably with (5) years in Regulatory

Required Experience:

- Experience in more than one functional area, i.e. clinical and regulatory affairs to ensure broad understanding of pharmaceutical development

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Extensive knowledge of all phases of drug development, of the functions and processes relevant to drug development, applicable to the biopharmaceutical environment

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Strong scientific expertise - translational development or correlative science expertise is preferred

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Experience with planning and execution of strategies for drug product registration and commercialization/life cycle management

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Proven ability to collaborate and work effectively with alliance management and partners

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In depth knowledge of hematology and/or oncology development and disease areas

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Broad understanding of strategic business objectives

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Significant line and matrix management experience

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10% Travel

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. 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:Distingusihed Scientist, Regulatory Liaison

Primary Location: NA-US-PA-Upper Gwynedd

Other Locations: NA-US-MD-Rockville, NA-US-MA-Boston, NA-US-NJ-Rahway

Employee Status: Regular

Travel: Yes, 10 % of the Time

Number of Openings: 1

Company Trade Name:Merck