Associate Director, Regulatory Project Management

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first- and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs.) Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, IM-1021, a ROR1 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview

The Associate Director, Regulatory Project Management, will lead the coordination and planning of regulatory submissions for drug and biologics across the pipeline, ensuring compliance with global regulatory requirements. This role will focus on the submission lifecycle management for major regulatory submissions, including clinical trial applications and amendments, marketing applications and post approval submissions. The individual will collaborate closely with cross-functional teams, including Regulatory Affairs, Clinical Development, Clinical Operations, Technical Operations (CMC), and Quality, to ensure timely, high-quality submissions in accordance with agency guidelines.

Responsibilities

Regulatory Submission Strategy & Planning:

• Lead the planning, preparation, and execution of regulatory submissions, ensuring alignment with regulatory and company goals.
• Work with Regulatory Affairs teams to develop submission strategies, timelines, and deliverables for global submissions, including FDA, EMA, and other international health authorities.
• Oversee the end-to-end submission lifecycle, including initial filings, amendments, supplements, and responses to health authority queries.

Project Management:

• Develop and maintain detailed submission project plans, including timelines, milestones, and critical path activities, ensuring all teams are aligned and on track.
• Coordinate cross-functional teams (e.g., Clinical, Nonclinical, CMC, Quality) to collect and organize data and documentation for regulatory filings.
• Proactively manage risks and project issues, implementing mitigation strategies to ensure submissions are completed on time and to the required quality standards.

Stakeholder Communication & Coordination:

• Serve as the primary point of contact for submission-related project management activities, ensuring effective communication between Regulatory Affairs, functional teams, and external partners.
• Facilitate submission readiness meetings and other project team discussions to ensure project milestones are met.
• Provide regular updates to senior management on submission progress, risks, and overall project health.

Compliance & Documentation Management:

• Ensure all submission-related documents are prepared in compliance with global regulatory requirements (FDA, EMA, etc.).
• Maintain accurate records of submission activities and ensure proper version control and archiving of documents within document management systems (e.g., Veeva, eCTD tools).
• Oversee compliance with submission guidelines, ensuring adherence to internal SOPs and regulatory requirements.

Continuous Improvement & Best Practices:

• Drive continuous improvement in regulatory submission processes, seeking opportunities to streamline workflows, improve efficiency, and enhance submission quality.
• Lead post-submission debriefs to capture lessons learned and apply best practices for future submissions.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, or related field; advanced degree (MS, PharmD, or PhD) preferred.
• a minimum of 8 years of regulatory submissions experience, with a minimum of 3 years in a project management role within the pharmaceutical, biotechnology, or medical device industry.

Knowledge and Skills

• Proven track record in leading and managing large regulatory submissions (e.g., IND, NDA, BLA, MAA) across global markets.
• Expertise in regulatory submission processes, CTD and global health authority guidelines (ICH, FDA, EMA, etc.).
• Project Management Professional (PMP) certification or equivalent experience in project management highly desirable.
• Experience with electronic document management systems and submission tools (e.g., Veeva, etc.).
• Excellent organizational, communication, and leadership skills.
• Ability to work effectively in a fast-paced, matrixed environment, managing multiple priorities and tight deadlines.
• Strong project management skills, with the ability to lead cross-functional teams and manage complex projects.
• Excellent communication skills to engage with stakeholders across functions and at all levels.
• Problem-solving and decision-making capabilities, with a focus on delivering high-quality regulatory submissions.
• Proficiency in using project management and regulatory submission tools.

Washington State Pay Range

$169,626-$191,547 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.