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Director of Program Strategy Management

Capricor Therapeutics, Inc.

Job Overview

Location

San Diego, CA

Job Type

Full-time

Full Job Description

📋 Description

• Own the end-to-end strategic roadmap for Capricor’s entire therapeutic portfolio, translating corporate vision into executable, milestone-driven plans that accelerate the delivery of life-saving cell and exosome therapies to patients with rare diseases.
• Serve as the single point of accountability for cross-functional program execution, orchestrating R&D, regulatory, CMC, operations, and quality teams to ensure every deliverable, timeline, and budget aligns with corporate objectives and investor milestones.
• Build and continuously refine integrated program plans using Smartsheet, MS Project, or Jira; produce real-time dashboards that surface critical path activities, resource gaps, and risk triggers for executive decision-making.
• Proactively identify, quantify, and mitigate program-level risks through scenario modeling, contingency planning, and cross-functional risk registers that keep late-stage assets like Deramiocel (CAP-1002) on track for FDA and EMA filings.
• Drive governance and stage-gate excellence by designing agendas, authoring briefing books, and presenting clear go/no-go recommendations to the CEO, CMO, and Board of Directors.
• Champion a culture of operational excellence by implementing standardized program management processes, SOPs, and KPIs that scale with Capricor’s growth from clinical-stage to commercial-stage biotech.
• Partner with Finance and Portfolio Strategy to build multi-year resource forecasts, capital allocation models, and scenario analyses that inform strategic partnerships, licensing deals, and investor communications.
• Mentor and upskill a high-performing Project Manager and matrix team members, fostering psychological safety, accountability, and a relentless focus on patient impact.
• Ensure every program activity meets FDA 21 CFR Part 11, EMA GMP/GCP, and internal Quality Management System requirements, collaborating with QA/RA to close gaps before they become compliance liabilities.
• Represent Capricor externally with key opinion leaders, patient advocacy groups, and regulatory agencies, translating complex scientific and regulatory updates into concise, actionable insights for internal stakeholders.
• Lead post-mortem and lessons-learned sessions after each program phase, institutionalizing best practices that continuously shorten development timelines and reduce cost of goods.
• Support BD&L and corporate development by providing due-diligence support, integration planning, and synergy modeling for potential acquisitions or platform expansions.
• Travel up to 15 % domestically and internationally to coordinate CMO/CRO activities, attend scientific conferences, and engage with regulatory health authorities.

🎯 Requirements

• Bachelor’s degree in life sciences, engineering, or business; advanced degree (MBA, MS, or PhD) strongly preferred.
• 10+ years of biotech or pharmaceutical program management experience, including at least 5 years leading late-stage (Phase II/III) cell or gene therapy programs.
• Demonstrated success managing cross-functional teams across R&D, regulatory, CMC, and quality in a matrix environment.
• Deep working knowledge of FDA, EMA, and ICH regulatory frameworks and GMP/GCP requirements.
• Expert-level proficiency in program management software (Smartsheet, MS Project, Jira) and advanced Microsoft Office skills.

🏖️ Benefits

• Competitive base salary of $200,000–$225,000 plus annual performance bonus and equity participation in a NASDAQ-listed company.
• Comprehensive health, dental, vision, and life insurance with 100 % employee premium coverage and generous dependent subsidies.
• Hybrid work model with flexible scheduling, modern San Diego HQ overlooking Torrey Pines, and quarterly team off-sites in inspiring locations.
• 401(k) with immediate vesting and 6 % company match, plus annual tuition reimbursement and professional development stipend.

Skills & Technologies

Remote

Degree Required

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Capricor Therapeutics, Inc.

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About Capricor Therapeutics, Inc.

Capricor Therapeutics is a late-stage biotechnology company developing cell and exosome-based therapeutics for Duchenne muscular dystrophy and other rare diseases. Its lead asset, CAP-1002, is an allogeneic cardiosphere-derived cell therapy in Phase 3 trials. The company also advances exosome vaccine candidates and exosome-mediated delivery platforms for RNA, proteins and gene therapies.

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