CMC Launch Lead (Director/Senior Director)
Reporting to: VP CMC Lifecycle Management
We are seeking an enthusiastic, highly motivated, and team-oriented leader for the newly established position of CMC Launch Lead, reporting to VP CMC Lifecycle Management.
Key Elements and Responsibilities
In this role, the incumbent will be responsible for the establishment of the CMC Launch function that will provide CMC support and guidance to the cross-functional teams responsible for Commercial Launch of Orchard's HSC based gene therapy products. The incumbent will engage with Global Supply Chain & Business Operations, External Development & Supply, Cell and Gene Therapy Technologies, Quality Assurance, Quality Control, Regulatory, and other departments on a variety of cross-program activities related to product launches.
Partner with CMC Project Management, Portfolio Program Management, and other functions as required, to establish program launch timelines, milestones, risk registers and mitigation plans to be aligned with overall program objectives and timeline. The CMC Launch Lead will have overall responsibility for ensuring that each CMC Lead and CMC Program Team have the information and guidance that they require in order to deliver on all CMC aspects of launch readiness.
Collaborate with Tech Ops functional leaders, including CGTT & CMC Lifecycle Management to allocate resources and budget to ensure successful delivery of CMC Launch milestones; anticipate bottlenecks and/or resource issues and escalate accordingly. Contribute to CMC sections of regulatory filings pertaining to product commercialization and launch. Provide consistent, cross-program CMC guidance and support for generation of launch-readiness materials including Product Manual, SmPC, PIL etc.
Work closely with Global Supply Chain & Business Operations and External Development & Supply, and the Commercial team to ensure lentiviral vector manufacture and supply meets the commercial demand forecast. Collaborate with Medical Affairs team to generate product-specific training materials and other literature as appropriate for treatment sites.
Collaborate with Global Supply Chain & Business Operations team to support all CMC aspects of Site Qualification process. Demonstrate excellent oral and written communication of complex information to executives, peers and regulatory agencies.
Industry experience in the Pharmaceutical sector developing ATMPs (experience with HSCs and Gene Therapies would be advantageous).
Skills & Abilities
*Takes the lead to interact and collaborate cross-functionally on broader Product Launch strategy and decisions
*Proactively seeks and analyzes information from a variety of sources to support decisions
*Takes an entrepreneurial and creative approach to developing new, innovative ideas that will optimize and challenge the status quo to deliver better results
Executing for Results
*Sets clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results
*Comfortable with ambiguity and uncertainty; confident to make decisions through complex situations
*Makes excellent decisions regarding complex issues and communicates decisions effectively with internal stakeholders, elevating complex issues as appropriate
* Self-reflective and leads by example; drives the organization's performance with an attitude for continuous improvement by being open to constructive feedback and self-improvement
Collaborations and Influence
*Creates collaborative and trusting relationships internally and with external partners
*Excellent verbal, presentation, and written communication skills. Can concisely articulate and deliver effective presentations on complex technical issues
*Encourages others to share the spotlight and celebrates and supports the success of the team
Min BSc., plus MSc/PhD or equivalent industry experience. 10-15+ years industry experience.