SUMMARY/JOB PURPOSE:**:**
This position oversees the overall success of delivery and execution within Pharmaceutical and Biological Operations, Manufacturing, and Supply Chain. This role drives the end-to-end execution of CMC development and manufacturing activities for small molecule and biologic programs, ensuring alignment with strategic objectives and timely achievement of milestones. The role provides strong operational leadership, cross-functional collaboration skills, and a proven track record in managing complex CMC programs across internal teams and external partners.
DUTIES/RESPONSIBILITIES: **:**
- Lead with Agility: Drive end-to-end execution of CMC development and manufacturing activities from early development through commercial readiness, adapting to evolving priorities and challenges.
- Ownership of Operational Delivery**: Translate strategic program goals into actionable operational plans; take full accountability for day-to-day execution of CMC deliverables.
- Foster Collaboration and Engagement: Build partnership across internal stakeholders and external CDMOs to ensure readiness for each phase of development and manufacturing.
- Solve Problems and Minimize Risk**: Proactively identify technical, operational, and supply risks; develop and implement mitigation strategies and resolve issues before escalation.
- Ensure Excellence in External Partnership: Monitor CDMO performance, ensure alignment with quality and regulatory standards, and drive accountability for results.
- Champion Strategic Initiatives: Drive or support PSC-wide initiatives focused on cost optimization, reliability, and patient-centric improvements.
- Demonstrate Executive Presence: Promote consistency, best practices, and continuous improvement across business operations in PSC. Influence decision making and drive alignment across key stakeholders.
ADDITIONAL RESPONSIBILITIES: **:**
- Provide meeting management support, including meeting planning, scheduling, facilitation, documentation (development of meeting agenda and minutes), and follow-up/follow-through on action items.
- Develop tools and dashboards to monitor key deliverables, decision points, risks, and critical path activities to drive delivery.
- Oversee material movement, inventory management, and liaise between internal contract/outsourcing team, technical teams, and CDMOs to coordinate contract related workstreams to ensure operational continuity.
SUPERVISORY RESPONSIBILITIES: **:**
- No direct supervisory responsibilities.
- Involves management of cross-functional teams of senior executives and functional teams in support of collaboration objectives.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: **:**
Education:
- BS/BA in a relevant drug or biological development discipline and thirteen years of related experience; or,
- MS/MS in a relevant drug or biological development discipline and eleven years of related experience; or,
- PhD in a relevant drug or biological development discipline and eight years of related experience; or,
- Equivalent combination of education and training.
Experience:
- Advanced degree (MBA, PhD) preferred.
- Requires at least five years of CMC development or project management experience in pharmaceutical or biotech field.
- Experience managing a portfolio of multiple products, and prioritization of activities and resources.
- Experience and prior knowledge of drug development for small and large molecules.
Knowledge, Skills and Abilities: **:**
- Effective communication skills, both oral and written. Comfort in interacting with much more senior personnel and across functional areas.
- Learning agility; ability to quickly grasp new concepts and processes.
- Determination and persistence in working through challenging and/or ambiguous business situations.
- Strong project management and organization.
- Committed to continuous improvement, both for individual responsibilities and contributions to PSC processes.
- Self-motivated, works with limited supervision. Seeks training and guidance when needed.
- Willingness to provide clear, pointed feedback to internal and external personnel.
- Negotiation and influence skills.
- Should be knowledgably about cGMP requirements and quality management systems for the pharmaceutical or biotechnology industry environment.
- Working knowledge of drug development process and the Federal laws and regulations affecting the pharmaceutical industry.
- Works on business cases and projects with high degrees of uncertainty and ambiguity; certain key business processes may be nascent or not yet formed.
- Requires frequent executive level communications (verbal and written) with internal and external stakeholders.
- Requires strong judgment, in accordance with both contractual terms and Exelixis culture, for structure of communication with internal/external parties and in ongoing decision-making.
- Networks with key contacts outside own area of expertise.
- Environment: primarily working indoors
- Travel required up to 20%
Work Environment/Physical Demands**: **:**
Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
WORKING CONDITIONS: **:**
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
