Executive Director, Lifecycle Lead

Responsibilities

• Lead integrated asset strategy across the full lifecycle, including research, clinical development, PV/PPQ, commercialization, and lifecycle management.
• Drive strategic planning for emerging therapeutic platform technologies.
• Evaluate portfolio opportunities and recommend development pathways, platform investments, and lifecycle expansion strategies.
• Partner with Research, Translational Sciences, and Clinical Development to enable seamless transition from discovery through development.
• Provide strategic oversight of manufacturing readiness, including process characterization, tech transfer, PV/PPQ, comparability, and supply chain readiness.
• Ensure alignment across Clinical Development, Manufacturing/MSAT & Supply, Quality, Regulatory, and Commercial teams for late-stage development and launch planning.
• Guide commercialization strategy, including launch readiness, market access, product differentiation, and lifecycle expansion.
• Partner with Project Management lead to develop and manage program timelines, action items, issues/risks and budget.
• Support governance decisions on manufacturing strategy, CDMO partnerships, network design, capacity planning, and commercial supply.
• Partner with Research, Translational Sciences, and Technical Development to advance next-generation therapeutic modalities and platform technologies.
• Ensure development strategies reflect platform-specific regulatory, manufacturing, clinical, and commercial considerations.
• Drive integrated multi-platform planning with focus on portfolio value and risk mitigation.
• Lead cross-functional planning for INDs, BLAs, label expansions, post-marketing commitments, and global lifecycle management.
• Work with third party technology and/or development partners to advance programs and operational plans

Qualifications

• PhD or advanced degree and 10+ years in bio/pharma industry as a program/LCL lead. 
• Proven experience in the field of biologics and autoimmune/oncology/hematology. A thorough knowledge of the pharmaceutical business model, of the value chain, especially in a Health Care environment. 
• Experience of working with research, clinical & non-clinical development or commercial collaborations with alliance partners. 
• Demonstrated Drug Development knowledge with understanding of the cross functional nature of the role including: Research, Translational Sciences, Clinical, Manufacturing, Commercial and Regulatory. 
• Strong command of clinical data and able to interpret complex data packets
• Experience with NDA, BLA filings and regulatory submissions for different parts of a lifecycle both early and late.
• Experience of working in an international environment.
• Demonstrated ability to drive initiatives, solve issues, pre-empt problems and achieve objectives.
• Ability to multitask and promote objective deliverables in resource constraint environment.
• Experience in cross-functional drug development and clinical-stage program management. 
• Understanding of the drivers of commercial success and the interplay between all customers, patients, physicians, pathologists/regulators payers etc.
• Ability to work effectively and manage stakeholders in a smooth & efficient way.
• Ability to drive delivery and advance complex global programs despite potentially adverse and changing conditions through effective governance and targeted executive escalation in a matrix organizational set up. 
• Experience and ability to innovate and guide the team to think and deliver creatively in order to generate value.
• Demonstrated expert judgment with the ability to quickly identify, analyze, evaluate, escalate and/or resolve problems, which could negatively impact global program implementation and/or financial results. 
• Excellent interpersonal and communication skills (verbal and written) with the ability to communicate and motivate with a persuasive, credible presentation style.
• Ability to resolve issues/ conflict in a constructive manner.
• Ability to develop bold ideas and take calculated risks.
• Strong tolerance for ambiguity, agility to adapt to change, confidence to speak-up and challenge appropriately.