Development Project Coordinator Jobs in Frederick, MD

Our client is a clinical-stage immunotherapy company developing next-generation therapeutics for cancer and autoimmune disease.

The company has a strong leadership team, was founded by an internationally recognized physician-scientist and is backed by a top-tier syndicate of institutional life sciences investors. Multiple assets are already in the clinic, spanning both biologic and oral small-molecule modalities across oncology and autoimmune indications. The company is well capitalized with multiple years of runway.

The Role

Our client is at the inflection point where a small company's greatest risk stops being the science and starts being the coordination. Three clinical programs are moving from Phase 1 toward Phase 2. Four to five preclinical programs are advancing behind them. Every one of those programs has a clinical timeline, a regulatory timeline, and a manufacturing timeline that have to converge — and right now they need one person who owns making that happen.

That is this role. You are the connective tissue across clinical, regulatory, and CMC, and the single source of truth on where every program actually stands.

This is not a role where you inherit a PMO. You build one — sized to a lean, fast-moving company, not imported wholesale from big pharma.

What You'll Own

Integrated program timelines

• Build and maintain integrated development plans for each clinical and preclinical program, with clinical, regulatory, and manufacturing workstreams on a single critical path.
• Identify dependencies and bottlenecks before they become delays — particularly where drug supply gates a study start or a regulatory interaction gates a protocol.
• Maintain the master portfolio timeline and keep leadership honest about what's real versus what's aspirational.

Phase 1 to Phase 2 transitions

• Drive the operational planning for three programs moving into Phase 2: study startup, site and vendor readiness, supply forecasting, and the regulatory steps that precede each.
• Coordinate end-of-Phase-1 activities and the data packages that support them.

Regulatory timeline management

• Partner with Regulatory to plan and track submissions, agency interactions, and the internal deliverables that feed them.
• Ensure functions deliver their components on schedule for INDs, amendments, briefing documents, and meeting requests.

Manufacturing and supply timelines

• Work with CMC and external CDMOs to align drug substance and drug product timelines with clinical demand.
• Own the visibility layer between manufacturing reality and clinical planning so supply never becomes a surprise.

Cross-functional program leadership

• Run program team meetings that produce decisions, not status recitals.
• Drive risk identification, mitigation planning, and scenario analysis across the portfolio.
• Manage external partners, CROs, and CDMOs against agreed timelines and deliverables.
• Prepare portfolio and program updates for executive leadership and the board.
• Establish the right level of process, tooling, and governance for a company this size — enough structure to move fast, not so much that it slows the science.

What We're Looking For

Required

• Bachelor's degree in a life sciences discipline; advanced degree (M.S., Ph.D., PharmD, MBA) welcome.
• 8+ years in biotech or pharmaceutical drug development project or program management, including direct ownership of clinical-stage programs.
• Hands-on experience managing Phase 1 and Phase 2 clinical program timelines.
• Demonstrated ability to build and manage integrated timelines spanning clinical, regulatory, and CMC/manufacturing workstreams — this is the core of the job.
• Experience coordinating external CROs, CDMOs and research partnerships.
• Working fluency in regulatory processes and submission timelines (IND, amendments, agency meetings).
• Strong command of project management tooling (MS Project, Smartsheet, Planisware, or equivalent) and the judgment to right-size it.
• The ability to influence without authority and hold senior scientists and functional leads to commitments.
• On-site full-time in Montgomery County, MD.

Nice to have

• Immuno-oncology or autoimmune development experience.
• Experience in a company under 100 people, where the PM function is built rather than inherited.
• PMP or equivalent certification.
• Experience supporting board-level portfolio reporting.

The reality of the role: this is a hands-on seat at a lean company. You will build the timelines yourself, run the meetings yourself, and chase the details yourself. The trade is real ownership across the entire portfolio and a direct line to the CEO.

Compensation and Benefits

Competitive package including base salary, target bonus, and equity, plus a 401(k) with company match, comprehensive healthcare benefits, and a flexible vacation policy.