Director Combination Product Development
We are currently looking for a Director for Combination Product Development to lead Regeneron in the creation and implementation of strategies for Drug Delivery Devices. In this leadership role, the director will provide oversight of device and combination product design innovation, new technology management, innovation protection, design control, product industrialization, human factors, and lab investigations. The Director’s scope of responsibilities encompasses the product lifecycle from conception/selection to clinical supply up to post market commercial support.A typical day in this role may include:
- Working to build a vision, developing strategies, securing support and resources and leading all aspects of strategic plans for Regeneron’s internal design, external collaboration, and industrialization of combination products.
- Leading a sophisticated and multifaceted Combination Product organization with responsibility for early and late phase development including internal product design and innovation, emerging technologies assessments, combination products design control and development, and human factors studies design and execution.
- Maintaining a positive and encouraging environment with a focus on excellence and professional development. While also, providing leadership and development opportunities for the team.
- Providing input for innovation and intellectual property protection related to Regeneron’s combination products.
- Providing support for the combination product lab and provide strategic direction to the business for the development of test methods, design control testing, fabrication, and investigation.
- Developing and sustaining relationships with alliance partners, internal customers (e.g. Quality, Regulatory Affairs, Legal), vendors, and external suppliers to support development projects’ success.
- Translating corporate and commercial strategies into concrete plans, overseeing the execution of these plans and ensuring timely and efficient delivery of commitments.
- Encouraging a continuous improvement mentality by regularly and directly pushing the status quo within team and with peers.
- Providing regulatory filing support (IND, BLA, MAA, etc.) and ensuring compliance with combination product regulations (i.e. FDA QSR 21 CFR 820 / ISO 13485).
- You have direct experience leading multifaceted organizations and serving as a primary point of contact representing the organization with external agencies, partners and vendors.
- You are an experienced leader and team-builder that can successfully bring products to market through close collaboration with vendors, external partners, Manufacturing, MSAT, Quality and Regulatory Affairs.
- You have excellent oral and written communication skills allowing for bringing complex information to leadership, peers, strategic partners and regulatory authorities.
- You can demonstrate sound understanding of regulatory, risk management, new technologies/trends and design control related fields (21 CFR Part 820, ISO13485, ISO14971, ISO11608 and other relevant global standards).
- You have an understanding of new product development and introduction, including design and development of extruded, molded and/or assembled device products as well as testing methodologies.
To be considered for this role you must have, a Ph.D. with 8+ years of combination product development experience preferred. We will also consider Master’s degree with 10+ years of related experience or Bachelor’s degree with 12+ years of experience. Also, a minimum of 6 years demonstrated experience in developing teams.
Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.