Director, Regulatory Affairs
*Note: candidates must be local to San Diego. Hybrid schedule available but this person will have a regular on-site presence
Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind virtually any protein, including proteins previously considered “undruggable”. Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first in class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders etc.) against undruggable targets in the oncology and immunology space.
We are uniquely structured with opportunities for all scientists to contribute to both established programs as well as ongoing early target selection, screens and validation. We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression.
Reporting into the Head of Regulatory, the Director, Regulatory Affairs, is a regulatory leader with expert technical and tactical experience in regulatory strategy and will be responsible for overseeing the development and implementation of advanced regulatory strategies for preclinical and clinical programs. He or she will play a major role in shaping cohesive regulatory strategy across programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy.
Essential Duties and responsibilities:
- Leads the development and implementation of regulatory strategy for complex projects in development (from first-in-human to post marketing application stages), including for regulatory submission documents and Health Authority communications
- Lead the preparation of submissions, which include INDs, Briefing Documents, Orphan Drug Applications, Clinical Trial Applications, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for assigned projects.
- Prepare company team for FDA and other health authority meetings, as required. Serve as the primary interface with vendors/partners for coordination and preparation of submissions.
- Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations, and guidance. Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
Education and Experience requirements:
- Bachelor’s Degree in a scientific discipline required; advanced degree preferred
- Minimum of 7 years of experience working in the pharmaceutical/biotechnology industry with direct experience in Regulatory Affairs
- Experience in small molecule drug development across multiple phases and in various therapeutic areas. Experience in immunology and oncology a plus.
- Thorough knowledge of the drug development process. Demonstrated experience in preparing health authority submissions (e.g., IND, pre-submission meetings, CTAs, etc).
- Demonstrated expertise with the interpretation of applicable regulatory frameworks and procedures, particularly with FDA, EU, and ICH guidelines related to pharmaceutical development of medicines for human use for clinical trial and marketing applications
- Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well-organized preparation of cross functional teams
- History of successful interactions with regulatory authorities
- Exercise outstanding judgment in all areas of responsibility
- Proven ability to effectively work collaboratively in cross-functional teams and lead team discussions
- Energetic, self-motivated and a hands-on professional with a strong work ethic
- Capable of performing independently and thinking analytically and creatively to solve problems
- Effectively multi-task to lead and manage time-sensitive projects
- Excellent communication and interpersonal skills required to enable optimal interactions both internally and externally
- A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems
- Experience with reviewing, authoring, or managing components of regulatory submissions
- Provides knowledge and expertise to guide team in establishing and implementing appropriate regulatory strategy
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, and integrity
In addition to a competitive compensation package with long-term incentives and 401k match, Vividion also offers a comprehensive benefits package for our employees and their families, which includes medical, dental, vision, life, and disability insurance.
Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.