Sr. Director, Regulatory Affairs
Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary geographically precise solutions (GPS) platform to build a pipeline of novel, tumor-activated molecules, including antibodies, cytokines and other biologics, which are designed to optimize their therapeutic index and localize anti-tumor activity within the tumor microenvironment. Xilio is currently advancing multiple programs for tumor-activated I-O treatments in clinical development, as well as programs in preclinical development. Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.)
The Sr. Director, Regulatory Affairs is responsible for the successful development and execution of regulatory strategy and regulatory operations across Xilio programs. This person works closely with colleagues across the company to design and execute global registrations strategies for all Xilio products. The Senior Director, Regulatory Affairs leads the development of regulatory documentation and leads regulatory interactions with global regulatory authorities for all development programs, initial regulatory efforts on pipeline programs, and develops and implements registration strategies consistent with Xilio business goals. In performing this role, the person must engender credibility and confidence within and outside the company and do so as an effective communicator and collaborator. This role reports directly to the Head of Program Leadership and Regulatory.
- Accountability for regulatory strategy:
- Oversees and directs all regulatory activities for all assets to ensure alignment and compliance with local and regional GxP requirements and registration requirements as well as with company policies.
- Represents Regulatory Affairs on Development Teams.
- Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Has ability to anticipate risks and takes responsibility for developing solutions to identified risks
- Monitors and anticipates trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
- Accountability for regulatory submissions/operations:
- Develops systems and processes for regulatory operations, working with vendors as needed, to assure compliant, scientifically valid submissions, globally.
- Manages and maintains all regulatory submissions, archives, and requirements.
- Assists cross-functional teams in compiling regulatory filing documents and maintaining electronic/paper files to support all documentation systems.
- Accountability for regulatory CMC submissions and activities:
- Develops and implements effective CMC regulatory strategies across products and product life cycles, working with Technical Operations and Quality Affairs
- Accountability for regulatory budget
- Develops and manages a functional budget and maintains it within financial goals; reviews and approves invoices against approved budget.
- Aligns functional growth (e.g., hiring, outsourcing, budgets) with company growth and changes consistent with guidance from Xilio leadership.
Skills, Qualifications, and Requirements:
- BS in a scientific/engineering discipline. Advanced degree preferred.
- At least 12 years of experience in biotechnology/pharmaceutical industry
- 8+ years of experience in Regulatory strategy, with experience in Oncology Development preferred.
- Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Oncology programs.
- Experience as primary regulatory author for IND and CTA documents.
- Strong experience with CTD format and content regulatory filings. Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide development teams in building appropriate global regulatory strategy.
- Able to handle multiple assignments in a fast-paced environment with changing priorities.
- Strong oral and written communications skills as well as presentation skills to leadership and peers at all levels.
- Role models respect, allyship and inclusion, creating a culture that fosters innovation and upholds Xilio values.
Xilio Therapeutics strongly encourages all employees to be vaccinated against COVID-19.
Diversity, Equity and Inclusion
At Xilio Therapeutics, we foster a culture of equity, diversity and inclusion. We consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability who requires an accommodation with the hiring process or to perform any essential functions of the position for which you are applying, please reach out to email@example.com.