Description

Job Description: Management and coordination of external and internal activities through IND-enabling studies.

Position Summary
We are seeking an accomplished, PMP (Project Management Professional) certified Project Manager to integrate and coordinate Internal and external Contract Research Organizations (CROs) and Chemistry, Manufacturing, and Controls (CMC) activities supporting program advancement through Investigational New Drug (IND) submission.

This role puts you at the heart of development, where you’ll energize partnerships with scientists and forward-thinking vertical stakeholders from every corner of the organization. As a dynamic matrix manager, you will spark innovation, pass the bottlenecks, unite diverse talents, and ignite momentum that makes things happen in time for patients in need. Both your people skills and creative drive will help weave together expertise and vision, turning bold ideas into real-world results.

The candidate will demonstrate a robust background in project management within the biotechnology sector, including hands-on experience with preclinical drug development, cGMP manufacturing, gene therapy, and cross-functional team leadership.

Key Responsibilities

• Serve as the primary point of contact between internal stakeholders and external CROs for all preclinical activities as well as cGMP CMC operations related to IND-enabling studies.
• Oversee and coordinate cGMP CMC activities, including management of external CDMOs, production and release of clinical trial materials, and assurance of compliance with regulatory standards.
• Develop, implement, and monitor project plans, timelines, and budgets to ensure the successful execution of preclinical and cGMP CMC studies.
• Coordinate the selection, contracting, and oversight of CROs and CDMOs, ensuring compliance with cGMP, regulatory requirements, and quality standards.
• Facilitate communication and collaboration across multidisciplinary teams, including Research, Regulatory, Clinical, CMC, and Quality Assurance units.
• Track project milestones, deliverables, and risks, proactively identifying and resolving issues to maintain program momentum in both preclinical and CMC domains.
• Prepare regular status reports, presentations, and updates for senior management and project teams, encompassing both preclinical and CMC progress.
• Ensure all data generated by CROs and CDMOs is appropriately documented, transferred, and archived in accordance with company policies and regulatory expectations.
• Lead or contribute to the preparation of documentation required for IND submission, including preclinical study reports and CMC regulatory filings.

Requirements

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related discipline (Master’s or PhD preferred).
• PMP certification required.
• At least 5 years’ experience in project management within a biotechnology in vivo gene therapy environment through early clinical development.
• Experience meeting or exceeding the timelines you have projected from preclinical drug development, cGMP manufacturing, gene therapy, and other IND-enabling studies.
• Prior experience with plasmid DNA and lentiviral manufacturing desirable.
• Experience managing technology transfer between external CROs, CDMOs, and vendors, particularly in the context of cGMP and CMC activities.
• Strong knowledge of cGMP requirements, CMC regulatory expectations, and the IND, PLI and BLA submission processes (FDA, EMA, etc.).
• Well recognized organizational, communication, and interpersonal skills.
• Ability to work independently, prioritize multiple tasks, and thrive in a dynamic, fast-paced environment within a matrix management structure.

Preferred Skills

• Experience with global CRO/CDMO management and multi-site studies or manufacturing campaigns.
• Familiarity with Good Laboratory Practice (GLP), cGMP standards, and pharmaceutical quality systems.
• Knowledge of risk management principles and mitigation strategies in drug development and manufacturing.
• Advanced problem-solving and negotiation skills.
• Familiarity with hematology oncology preferred.
• Required experience with MS Project, Azure365 platforms (including Co-pilot tools), and electronic laboratory notebook (ELN) systems.

Benefits

• Health and medical insurance with up to 85% of insurance premiums paid by the Company.
• 401K plan with employer match of 50% of employee contributions up to first 6% of eligible compensation.
• Discretionary bonus of up to 20% of base compensation.
• 12 paid holidays.
• PTO of up to 120 hours per year.

Application Process
Interested candidates should submit a resume, cover letter, and proof of PMP certification. Please highlight experience in oversight of preclinical, gene therapy, cGMP CMC programs, and external vendors leading to IND submission.