Sr. Manager, Product Launch

Role Summary

Senior Manager of Product Launch to lead high-impact, end-to-end launches of innovative therapies across global markets. This high-profile, fast-paced role demands a strategic, patient-focused leader who excels at navigating regulatory complexity, driving cross-functional alignment, and delivering on-time, compliant market availability. You will shape integrated launch strategies, mitigate critical risks, and champion launch excellence to accelerate patient access to life-changing treatments. Ideal for a proven biotech/pharma executive with deep launch expertise, strong business acumen, and the ability to influence at senior levels in a dynamic, regulated environment.

Responsibilities

• Develop and oversee comprehensive, integrated launch plans—including timelines, dependencies, risks, resources, and market-specific requirements—while aligning technical, regulatory, supply chain, and commercial objectives.
• Partner with Product Strategy leaders to craft cohesive development-to-commercial strategies that incorporate competitive intelligence, market insights, and patient-centric value propositions.
• Establish standardized processes, tools, dashboards, and KPIs to drive global launch excellence and continuous improvement.
• Form and lead high-performing cross-functional launch teams (commercial, regulatory, supply chain, manufacturing, quality, and beyond) to meet ambitious timelines.
• Build strategic partnerships and influence senior stakeholders across functions without direct authority, fostering accountability, clarity, and collaborative decision-making.
• Ensure full adherence to global regulatory standards (e.g. FDA, EMA, ICH, cGMP) while proactively anticipating and resolving CMC, labeling, and access challenges to safeguard compliance and market entry.
• Translate strategic commitments into executable plans, monitor readiness KPIs, and lead rapid resolution of issues across manufacturing, quality, logistics, data, and packaging domains.
• Identify, track, and mitigate multi-domain risks with a resilient, crisis-management mindset focused on forward momentum and contingency planning.
• Champion process simplification, digital tools, data automation, lean methodologies (DMAIC), and innovative approaches to embed launch excellence and adaptability.

Qualifications

• Required: Bachelor's degree in Life Sciences, Engineering, Supply Chain Management, Business Administration, or related field.
• Required: PMP certification or equivalent.
• Preferred: MBA or Master's in Supply Chain, Business, or Engineering.
• Required: 7+ years leading product launches into global biotech/pharma markets, with proven success in New Product Introduction and market timing processes.
• Required: In-depth knowledge of pharmaceutical regulatory environments, GMP, and ICH guidelines.
• Preferred: Lean-DMAIC (Green Belt or higher).
• Required: Demonstrated ability to manage complexity, balance priorities, lead change, and drive cross-functional improvements in regulated settings.
• Required: Proficiency in Microsoft applications, PowerBI, SAP, or similar technologies.

Skills

• Decision Making & Strategic Acumen — Makes independent, complex decisions with material impact; distills critical insights from ambiguous challenges; gathers diverse inputs for sound conclusions; applies financial/business acumen and competitive/market intelligence to optimize positioning, access, and ROI.
• Influencing & Collaboration — Navigates inter-departmental dependencies; shares information transparently to align goals; listens actively, incorporates feedback, and partners across teams; builds relationships with KOLs, payers, and external stakeholders to drive advocacy and adoption.
• Agility & Resilience — Develops options to overcome setbacks; anticipates problems with deep process knowledge; seeks advice swiftly; maintains positive, solution-focused momentum in crises and fast-paced change.
• Leadership & Patient-Centric Orientation — Guides team development from foundational to advanced tasks; resolves conflicts to sustain teamwork; aligns launches with long-term portfolio vision and unmet patient needs, translating scientific complexity into compelling value.
• Innovation & Adaptability — Champions continuous learning and innovative practices (e.g., digital tools, agile adaptations in regulated settings) while operating autonomously across global regions and time zones with exceptional communication and influencing skills.

Education

• Bachelor's degree in Life Sciences, Engineering, Supply Chain Management, Business Administration, or related field.
• PMP certification or equivalent.
• Preferred: MBA or Master's in Supply Chain, Business, or Engineering.

Additional Requirements

• Work Style: Hybrid – onsite in San Rafael at least two days/week.
• Travel: Approximately 15% travel.