Sr. Manager, Product Launch
BioMarin Pharmaceutical Inc.
5 months ago
Remote
United States
Marketing
Key Responsibilities
- Develop and oversee comprehensive, integrated launch plans—including timelines, dependencies, risks, resources, and market-specific requirements—aligning technical, regulatory, supply chain, and commercial objectives.
- Partner with Product Strategy leaders to create development-to-commercial strategies using 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 cross-functional launch teams (commercial, regulatory, supply chain, manufacturing, quality, and beyond) to meet ambitious timelines.
- Build partnerships and influence senior stakeholders across functions without direct authority, fostering accountability, clarity, and collaborative decision-making.
- Ensure adherence to global regulatory standards (e.g., FDA, EMA, ICH, cGMP), proactively resolving CMC, labeling, and access challenges to safeguard compliance and market entry.
- Translate strategic commitments into executable plans; monitor readiness KPIs; lead rapid resolution of issues across manufacturing, quality, logistics, data, and packaging.
- Identify, track, and mitigate multi-domain risks using a crisis-management mindset with contingency planning.
- Champion process simplification, digital tools, data automation, and Lean methodologies (DMAIC) to embed launch excellence and adaptability.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Supply Chain Management, Business Administration, or related field.
- PMP certification or equivalent.
- 7+ years leading product launches into global biotech/pharma markets, including New Product Introduction and market timing processes.
- In-depth knowledge of pharmaceutical regulatory environments, GMP, and ICH guidelines.
- Lean-DMAIC expertise (Green Belt or higher preferred).
- Demonstrated ability to manage complexity, balance priorities, lead change, and drive cross-functional improvements in regulated settings.
- Proficiency in Microsoft applications, PowerBI, SAP, or similar technologies.
Preferred Qualifications
- MBA or Master’s in Supply Chain, Business, or Engineering.
Work Style
- Remote capacity; approximately 15% travel.
- Develop and oversee comprehensive, integrated launch plans—including timelines, dependencies, risks, resources, and market-specific requirements—aligning technical, regulatory, supply chain, and commercial objectives.
- Partner with Product Strategy leaders to create development-to-commercial strategies using 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 cross-functional launch teams (commercial, regulatory, supply chain, manufacturing, quality, and beyond) to meet ambitious timelines.
- Build partnerships and influence senior stakeholders across functions without direct authority, fostering accountability, clarity, and collaborative decision-making.
- Ensure adherence to global regulatory standards (e.g., FDA, EMA, ICH, cGMP), proactively resolving CMC, labeling, and access challenges to safeguard compliance and market entry.
- Translate strategic commitments into executable plans; monitor readiness KPIs; lead rapid resolution of issues across manufacturing, quality, logistics, data, and packaging.
- Identify, track, and mitigate multi-domain risks using a crisis-management mindset with contingency planning.
- Champion process simplification, digital tools, data automation, and Lean methodologies (DMAIC) to embed launch excellence and adaptability.
Required Qualifications
- Bachelor’s degree in Life Sciences, Engineering, Supply Chain Management, Business Administration, or related field.
- PMP certification or equivalent.
- 7+ years leading product launches into global biotech/pharma markets, including New Product Introduction and market timing processes.
- In-depth knowledge of pharmaceutical regulatory environments, GMP, and ICH guidelines.
- Lean-DMAIC expertise (Green Belt or higher preferred).
- Demonstrated ability to manage complexity, balance priorities, lead change, and drive cross-functional improvements in regulated settings.
- Proficiency in Microsoft applications, PowerBI, SAP, or similar technologies.
Preferred Qualifications
- MBA or Master’s in Supply Chain, Business, or Engineering.
Work Style
- Remote capacity; approximately 15% travel.