Vice President of Regulatory Affairs
Elucida Oncology, Inc. is a Monmouth, New Jersey based biotechnology company committed to developing targeted C’Dot Drug Conjugates, or CDCs, for the treatment of cancer. Elucida Oncology is currently identifying lead CDC candidates and anticipates initiating clinical studies in mid-2021.
Elucida’s C’Dot platform has unique properties due to its ultra-small size and composition that enables CDCs to both rapidly target and penetrate tumors, even those in difficult to access regions like the brain, and to clear from the body primarily through the kidneys. Our CDCs are functionalized with multiple targeting ligands to promote tumor-targeting specificity and potent payloads via linkers designed to maintain their stability in the circulation and release in the tumor. Our lead program is centered around the targeting of topoisomerase 1 inhibitors to folate receptor alpha overexpressing tumors.
Elucida is seeking an experienced and motivated Head of Regulatory Affairs to join our rapidly-growing organization. Reporting to the CMO/CEO, this critical position will be responsible for leading and implementing strategic and operational regulatory plans for the development of current and future indications. The individual will also play an important role in maintaining effective communication and constructive working relationships with both internal and external collaborators and regulatory authorities. As the first full-time regulatory position at Elucida, this role provides the unique opportunity to see quick results through the application of the individual’s work and knowledge. As the company grows, the incumbent will have the ability to contribute to building the organization and further advancing his/her leadership position.
- Manage and lead the regulatory affairs function, providing strategic leadership and operational excellence, with full functional responsibilities.
- Develop appropriate regulatory strategies for projects particularly at early stages of development, in collaboration with cross-functional members in areas such as Medical, CMC, preclinical and project management.
- Function as the primary resource and conduit for senior leadership on all Regulatory matters.
- Serve as the primary point of contact for all regulatory agency interactions, including the preparation and regulatory leadership for key meetings including pre-IND, IND, End of Phase 2 and pre-NDA/BLA.
- Interact with regulatory agencies with intelligence and diplomacy. Develop and maintain strong relationships with regulatory agency staff.
- Manage the preparation and timely submission of regulatory documents, including IND’s, briefing documents for key meetings, NDA’s/BLA’s, Dossiers, responses to regulatory requests and required periodic reports.
- Utilize development expertise to advise teams on broader development issues. Provide a big picture, unbiased perspective in all development discussions, seeking approvable development packages capable of commercial success.
- Collaborate with third party regulatory and regulatory CMC consultants, and CRO’s to supplement expertise and operational capacity.
- Serve as the subject matter expert on regulations, guidance documents, contemporary regulatory practices and relevant regulatory precedence to guide the overall development plans accordingly. Proactively monitor changes in the regulatory environment.
Experience, Education and Specialized Knowledge and Skills
- PhD or Master’s degree in a relevant scientific area.
- 10 - 15 years of bio/pharmaceutical experience in drug development with progressively increasing responsibilities in regulatory affairs.
- Oncology experience with a significant level of interaction with the relevant FDA review divisions highly preferred.
- Experience working with the FDA is required. Global regulatory clinical trial experience and regulatory CMC experience are a plus.
- Deep regulatory experience is essential, including experience with developing broad plans for phase 1 through phase 3. Experience with pivotal trials and product registration and NDA regulatory experience is a plus.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Attention to detail and quality are critical to success.
- Able to command respect from peers and capable of highly independent work as well as being a team player and role model.
- Highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
- Proven ability to manage multiple projects, identify and resolve issues.
- Broad experience in a small company environment is a plus
- Ability to travel up to 25%
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel is required.
Elucida Oncology is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
Please fill out the form below to submit your application.