Preclinical Program Manager – Fortitude Biomedicines – Boston

Job
USA
October 14, 2025

Job Overview

Job Description

Fortitude Biomedicines is a cutting-edge biotechnology company dedicated to advancing immunotherapy and biologics research. Our team is committed to developing transformative treatments that harness the power of the immune system to address unmet medical needs.

Position Summary

We seek a biopharma industry veteran to join us in the newly created role of Preclinical Program Manager. With a focus on supporting our IND-enabling studies for biologics and ADCs, this role is critical to ensuring the smooth progression of our preclinical programs through effective timeline management, coordination with internal and external stakeholders, and proactive risk identification. The ideal candidate will have hands-on experience with IND filings and managing preclinical CROs, along with exceptional communication skills to foster cross-functional collaboration in our fast-paced startup setting.

Essential Duties and Responsibilities

  • Manage IND-enabling studies for biologics and ADCs, ensuring compliance with regulatory requirements and timely progression toward IND submission.
  • Coordinate with internal discovery teams to oversee external CRO activities, including study design, execution, and data analysis.
  • Manage timelines and deliverables across multiple projects, tracking progress and adjusting plans as needed.
  • Facilitate cross-functional coordination between internal teams (e.g., discovery, regulatory, CMC) and external partners (e.g., CROs, consultants).
  • Organize and manage meetings, including agenda preparation, facilitation, and documentation of meeting minutes to ensure clear action items and follow-up.
  • Proactively identify potential risks in preclinical programs, develop mitigation strategies, and communicate them effectively to stakeholders.
  • Support vendor selection, contract negotiation, and performance oversight for preclinical CROs.
  • Conduct competitive intelligence analysis to evaluate industry trends, benchmark program performance, and inform strategic decision-making.
  • Contribute to the preparation of IND documentation, leveraging prior experience to guide the team through regulatory processes.
  • Foster an entrepreneurial spirit by adapting to evolving priorities and contributing innovative ideas to accelerate program advancement.

Qualifications – Education

Bachelor’s or Master’s degree in Biology, Pharmacology, Biotechnology, or a related field;

Qualifications – Work Experience and Skills

  • At least 5 years of experience in preclinical program management within the biotech or pharmaceutical industry, with a focus on biologics and/or ADCs.
  • Proven track record of successful IND filings, including hands-on involvement in preparing and submitting IND applications.
  • Demonstrated experience managing preclinical CROs, including study oversight, budgeting, and quality assurance.
  • Strong project management skills, including expertise with project management tools used for timeline tracking, resource allocation, and milestone achievement.
  • Excellent communication skills, both written and verbal, with the ability to present complex information clearly to diverse audiences.
  • Ability to thrive in a fast-paced, entrepreneurial environment, with a proactive mindset and strong problem-solving abilities.

Preferred Skills

  • Familiarity with regulatory guidelines (e.g., FDA, ICH) for IND-enabling studies in biologics and ADCs.
  • Experience with risk management frameworks and tools in preclinical development.
  • Proficiency in project management software (e.g., Microsoft Project, Asana) and data analysis tools.
  • PMP certification is a plus
  • Prior experience in an early-stage startup or small biotech company.

We offer a competitive salary, equity options, and opportunities for professional growth in a collaborative, innovative culture. If you are passionate about advancing groundbreaking therapies and ready to contribute to our mission, please apply today!

Physical Requirements

Physical requirements are typical of those for an office position including ability to work on a computer for extended periods.

Fortitude Biomedicines is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.