Shattuck Labs, Inc. (www.shattucklabs.com) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, ARC®, platform simultaneously inhibit checkpoint molecules and activate costimulatory molecules within a single therapeutic. The company’s lead wholly owned program, SL-172154 (SIRPa-Fc-CD40L), which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in a Phase 1 trial. A second compound, SL-279252 (PD1-Fc-OX40L), is being evaluated in a Phase 1 trial in collaboration with Takeda Pharmaceuticals. Additionally, the company is advancing a proprietary Gamma Delta T Cell Engager, GADLEN™, platform, which is designed to bridge gamma delta T cells to tumor antigens for the treatment of patients with cancer. Shattuck has offices in both Austin, Texas and Durham, North Carolina.
About the Position
The Director of Regulatory Affairs will be responsible for contributing to the development and overseeing the implementation of global regulatory strategies for assigned programs in alignment and in compliance with local and regional regulatory requirements, and company policies. This role will ensure effective communication with business partners and regulatory authorities worldwide, including planning and leading meetings with regulatory authorities. This position will oversee and provide direct input to global regulatory strategy and submissions for therapeutic biological projects in both early and late development, including submission of high-quality INDs/CTAs, BLAs/MAAs, meeting packages, amendments, and required elements such as safety reports, annual reports. The person fulfilling this role will work as part of a growing Regulatory Team in a dynamic company. The ability to function independently as well as work collaboratively as part of a project team, including with external contract research organizations is a must. The opportunity for professional growth is abundant as programs are complex and may involve multiple indications, combination therapies, companion diagnostics, and expedited regulatory pathways. Shattuck will provide industry competitive salary, equity and bonus, as well as a competitive benefits package including: health, dental, vision, 401K and vacation time.
Summary of Key Responsibilities:
• Provide regulatory strategic input for global drug development projects, including but not limited, to regulatory requirements, opportunities for expedited development, timing and content of agency interactions to support successful development programs.
• Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities including INDs, CTAs, BLAs, MAAs, amendments, safety reports, and annual updates/DSURs for assigned projects.
• Interpret and communicate regulatory expectations to stakeholders in order to execute program objectives in compliance with applicable regulations.
• Maintain an awareness and apply a comprehensive understanding of relevant regulations and guidelines to enhance probability of regulatory success and ensure regulatory compliance.
• Ensure that company and project team objectives and timelines are supported by regulatory deliverables.
• Provide de-risking development strategies and evaluate opportunities to accelerate development in a fast-paced environment.
• Represent Regulatory Affairs on global project teams, sub-teams, and external alliances as needed.
• Provide support to clinical study related activities, including interacting with CROs and other external parties as needed.
• Contribute to the development of policies, procedures and best practices in a rapidly growing company.
• Work as a member of a team, fostering constructive working relationships with internal and external colleagues.
• Potential to oversee internal or external staff contributing to regulatory submissions.
Qualifications and Experience
• Bachelor’s Degree in clinical, scientific, medical or industry-related discipline is required; Advanced degree (MS, PharmD, PhD) preferred.
• Minimum of five years experience as a regulatory professional in the bio/pharmaceutical industry, including experience interacting directly with regulatory agencies.
• Proven track record of successful regulatory submissions, including major submissions (e.g., IND, CTA, BLA, NDA).
• Excellent knowledge of FDA and European regulations and guidance documents.
• Knowledge of drug development, clinical study design, biostatistics, pharmacokinetics, the regulatory environment.
• Exercises good judgement in elevating and communicating actual or potential issues to line management.
• Extensive global regulatory knowledge and experience.
• Experience with biologics drug development.
• Experience with oncology, especially immuno-oncology drug development.
• Ability to thrive in a collaborative and fast-paced team environment.
• Experience in both early and late-stage drug development.
Skills and Competencies:
• Proven track record of effective collaboration with multi-faceted project teams
• Excellent written and oral communication skills with an ability to clearly articulate regulatory viewpoints to diverse audiences
• Excellent interpersonal skills
• Ability to work independently in a highly dynamic drug development environment
• Capable of multi-tasking, setting priorities, and meeting timelines
• Strong project management skills and drive for excellence