Associate Director, Pre-Commercial Launch Lead - 12 Month Fixed Term Contract, Dublin

Social network you want to login/join with:

Associate Director, Pre-Commercial Launch Lead - 12 Month Fixed Term Contract, Dublin

Client: Alexion Pharmaceuticals Location: Dublin, Ireland Job Category: Other EU work permit required: Yes Job Reference: 8fcdd1e17e7e Job Views: 12 Posted: 21.01.2025 Expiry Date: 07.03.2025

Job Description:

The Associate Director, Pre-Commercial Launch Lead (GOLT Lead) role sits within the Alexion Product Management Team in Global Supply Chain & Strategy and plays a critical role in partnering with the Strategic Product Leads (SPLs) to develop and deliver operational launch strategies. This position requires aligning, leading, collaborating, and influencing across functional barriers to establish supply chains and execute global product launches of new products and new product presentations. Our New Product portfolio has grown significantly, and we are handling an increasing level of complexity with our launches. This role is pivotal in managing this complexity, including small molecules, biologics, and external partnerships while accelerating launch timelines. The GOLT Lead ensures that the Global Operations Launch Teams (GOLTs) operate effectively and deliver the operations launch strategy agreed with the Global Program Teams (GPTs) and the PDCS (Product Development & Clinical Supply) CMC Teams. Additionally, the position will manage/own one or more key business processes related to the launch of new products.

Accountabilities

1. Work closely with PDCS CMC Program Management team to ensure the transition from PPQ to launch batches at all manufacturing stages (DS, DP, and FP).
2. Lead Global Operations Launch Teams (GOLT) to successfully execute global launches by leading multi-disciplinary teams and working with our markets worldwide ensuring:

• Our supply chains are launch ready.
• Timely supply of registration samples, packaging, and artwork for submission.
• Delivery of launch stock for market launches.

• Lead all regional or market-specific launch meetings to confirm and align on launch assumptions, including product security features, EAP/Clinical transition to commercial SKU, and potential risks.
• Complete preparation/planning/risk management for launch supply including securing availability of API/BDS & formulated product in alignment with Reg waves of submission/approval.
• Engage actively with partners across the business to understand the global launch expectations, market scope/requirements, and potential needs for acceleration, ultimately ensuring the timely delivery of launch stock to markets.
• Drive continuous improvement initiatives, focusing on process standardization, automation, and digitization related to launch activities.
• Act as Project Manager for the onboarding of new manufacturing sites (internal and external) selected for the launch of new molecule entities or for the launches of new product presentations.
• Responsible for the transition from GOLT to Brand Expansion team to ensure the continuity of launch activities for tail market launches.
• Proactively manage complex risks and challenges using supply chain knowledge and network insights to develop innovative solutions. Ensure these solutions are embedded and shared across the business.
• Build strong relationships across the global organization, displaying cultural awareness and adaptability.
• Ensure compliance with GMP and regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility.
• In addition to the GOLT responsibilities, manage/own one or more key business processes.
• Deliver solutions needed by being entrepreneurial and patient-focused.

Essential Skills/Experience

1. 5+ years working experience in a biopharmaceutical or pharmaceutical company having held accountability for the implementation of high-profile projects, ideally in operational launch readiness or Life Cycle Management.
2. Project management experience in Pharmaceutical or related environment.
3. Knowledgeable about Smartsheet and other Project Management tools/systems.
4. Experience of working cross-functionally with R&D and Commercial in a matrixed environment.
5. Excellent level presentation skills and polished written and oral communication ability.
6. Ability to engage with senior management in Operations and cross-functionally.
7. Experience in identifying areas for improvement and driving process changes.
8. Good understanding of Risk Management.
9. Strategic thinking, balancing short and long-term priorities.

Desirable Skills/Experience

1. Science, Engineer or Business Degree required.
2. Project Management Qualification desired.
3. Advanced degree (MS, PhD, MBA) is an advantage.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world. Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave, pioneering spirit – we are truly unique in R&D and healthcare. At Alexion, grow and innovate in a business with a rapidly expanding portfolio. Enjoy the vibe, entrepreneurial spirit, and autonomy of a leading biotech. You’ll join an energizing culture where people build connections to explore new ideas and learn. As an important member of our commercial team, you'll be meeting the needs of some of the most under-served patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patient's journeys. You’re supported by exceptional leaders and peers ready to lift you in marketing, compliance, and beyond. Date Posted: 08-Jan-2025 Closing Date: 04-Feb-2025 Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. #J-18808-Ljbffr