Director, Preclinical Development

Job Description: Director, Preclinical Development 

Location: Remote, preferred in the US

Company: OS Therapeutics Inc., a Delaware corporation (“OS Tx”)

About OS Tx

OS Therapeutics is a fast-growing US biotech company build around a mission to make the impossible possible for patients facing difficult-to-treat diseases. We are pioneering next-generation therapeutics that turn breakthrough science into life-changing therapies. That vision is built on a validated scientific platform, a focused strategy with a clear development roadmap, and a team with a track record of disciplined execution. Together, they position us toward a bold ambition: bringing transformative medicines to the patients and improving lives with speed and scientific discipline.

Position Overview

OS Tx is seeking an experienced and hand-on Director, Preclinical Development to lead the advancement of our nonclinical programs through IND submission. Reporting directly to the Chief Operating Officer (COO), this individual will oversee critical aspects of preclinical development, including DMPK/PK-PD, nonclinical safety (toxicology), and regulatory strategy, ensuring the delivery of a comprehensive and high-quality IND-enabling package. Operating in a lean, fast-paced startup environment, the Director will partner closely with the leadership team and external partners to design and execute robust IND-enabling studies and prepare IND/CTA submissions, establishing the scientific and regulatory foundation for successful first-in-human clinical studies.

Key Responsibilities

• Lead the nonclinical development strategy from preclinical candidate (PCC) selection through IND submission, integrating DMPK/PK-PD, toxicology, and regulatory into a comprehensive and stage-appropriate development plan.
• Direct DMPK/PK-PD activities, including design, oversight and interpretation of ADME, PK/PD, and bioanalytical studies to support candidate selection, translational strategy, dose projections, and first-in-human dose recommendations.
• Oversee the IND-enabling safety assessments, including GLP toxicology, safety pharmacology, and related studies, ensuring scientific rigor, regulatory compliance, and alignment with development timelines and agency expectations.
• Drive regulatory execution by coordinating the planning, preparation, authoring, and submission of IND and CTA applications, while ensuring high-quality, inspection-ready documentation.
• Manage external partners and CROs, providing strategic oversight of study execution, budgets, timelines, deliverables, and data quality to ensure efficient and successful program advancement.
• Author and review nonclinical sections of regulatory documents, including IND, Investigator’s Brochure, briefing packages and represent nonclinical in health-authority interactions.
• Align nonclinical and regulatory milestones with corporate goals and communicate progress and data-driven recommendations to leadership.

Qualifications

• PhD in Pharmacology, Pharmaceutical Sciences, Toxicology, DMPK, or a related discipline (PharmD or equivalent considered)
• Strong scientific foundation in nonclinical drug development, with expertise in translational pharmacology and IND-enabling development.

Experience

•  10 years of industry experience in nonclinical drug development, with significant expertise in DMPK/PK-PD strategy and execution
• Demonstrated experience of designing and interpreting ADME, PK/PD, and bioanalytical studies to support candidate selection, translational modeling, dose optimization and human dose projection
• Broad understanding of nonclinical safety assessment/toxicology and regulatory requirements, with practical, hands-on experience advancing programs from PCC through IND submission
• Experience authoring nonclinical sections of IND/CTA filings and managing GLP toxicology and DMPK and other non-clinical studies through external CROs
• Preferred experience with global / multi-region regulatory submissions, leading pre-IND and other health-authority meetings

Desired Attributes

• Hands-on, pragmatic, and resourceful—comfortable rolling up sleeves and executing.
• Strong interpersonal skills and the ability to build trust across scientific, operational, investor, and partner ecosystems.
• High personal integrity and ability to handle confidential information with discretion.

Why Join OS Tx?

• Opportunity to shape and build a pioneering biotech company at a formative stage.
• Collaborative and innovative culture with direct exposure to scientific and corporate decision-making.
• Meaningful career growth opportunities as the company scales toward clinical development.
• Competitive compensation and benefits package (details below).

Compensation and Benefits

OS Tx offers competitive benefits and compensation to all employees, regardless of their location, including medical insurance, dental insurance, 401k program, vacation, and paid holidays. In addition to base salary, other compensation may include an annual discretionary merit bonus and/or participation in an employee stock option plan. Any form of additional compensation offered by OS Tx may be subject to the terms and conditions of an applicable policy, bonus or stock plan determined by OS Tx, in its sole discretion, based on individual and/or Company performance. This compensation and benefits information is based on OS Tx’ reasonable expectation as of the date of publication of this job posting. OS Tx may modify any of the compensation and benefits provided to employees at any time, in its sole discretion.

Application Process

To apply, please submit your resume and a brief cover letter outlining your qualifications and interest in the role to hiring@ostherapeutics.com.

OS Tx is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.