Director, CMC Project Management

About Jade Biosciences

Jade Biosciences is focused on developing innovative, best‑in‑class therapies to address critical unmet needs in autoimmune diseases. Our lead candidate, JADE101, is designed to inhibit the cytokine APRIL (A Proliferation‑Inducing Ligand) and is being developed for the treatment of immunoglobulin A nephropathy (IgAN), a chronic kidney disease that can impair kidney function over time. JADE101 aims to reduce harmful IgA antibodies, lower proteinuria (a key marker of kidney damage), and preserve long‑term kidney function. A Phase 1 healthy‑volunteer study of JADE101 is ongoing, with interim, biomarker‑rich data expected in the first half of 2026. Jade’s pipeline also includes a second development candidate, JADE201, and an undisclosed antibody discovery program, JADE‑003, both currently in pre‑clinical development. For more information, visit JadeBiosciences.com and follow us on LinkedIn.

Role Overview

As the Director, CMC Program Management, you will be responsible for facilitating CMC planning and cross‑functional alignment for our drug development programs to enable successful execution. You will need attention to detail, proficiency in forward planning and organizational skills, and effective stakeholder management. This position reports to the Executive Director of CMC.

Key Responsibilities

In collaboration with the CMC team members, facilitate management of the CMC activities for our drug development programs, ensuring they are completed on time, within budget, and according to company goals.

Work closely with CMC quality assurance and CMC regulatory to ensure effective collaboration and execution of CMC deliverables.

Maintain integrated CMC development plans across our candidate programs and proactively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs.

Collaborate with cross‑functional program managers to effectively communicate CMC activities and ensure alignment with overall program goals and timelines.

Track program risks, proactively identifying and resolving issues, and working cross‑functionally to develop contingency plans to ensure program success.

Manage relationships with external partners, vendors, and contractors as required to ensure smooth program execution.

Support development and refinement of processes, tools, and systems to deliver high‑quality PM support to the CMC programs.

Qualifications

Bachelor’s degree in a related field required; advanced degree preferred.

15+ years of experience in CMC program management within the biotech or pharmaceutical industry.

PMP certification preferred.

Strong experience in providing program management to CMC teams while interacting with cross‑functional teams.

Knowledge and understanding of CMC early‑stage development pathways, including cell line development, drug substance and drug product manufacturing processes, analytical, formulation and stability studies.

Preferred knowledge and understanding of CMC late‑stage development including process characterization, process and method validation, tech transfers and comparability studies. Experience in managing programs for combination products is also desirable.

Excellent organizational skills and ability to forward‑plan.

Proven track record of successful project management of complex drug development programs in a fast‑paced startup environment.

Expertise with project management tools (e.g., Smartsheet, Microsoft Timeline Pro+).

Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast‑paced environment.

Proactively identifies issues and drives resolution; can anticipate key future events and adjust team priorities / plans accordingly.

Excellent communication and interpersonal skills with the ability to influence and motivate cross‑functional teams, manage a diverse set of stakeholders, and work closely with team leaders.

Strong written and oral communication skills with strong attention to detail.

Position Location

This is a remote role; periodic travel to team and company events is required.

Salary

The anticipated salary range for this role is $210,000 – $235,000. The final salary offered will depend on several factors, which may include, but are not limited to, relevant years of experience, educational background, and geography.

EEO Statement

Jade Biosciences is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

#J-18808-Ljbffr