Executive Director, Lifecycle Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Direct the integrated asset strategy throughout the entire lifecycle, encompassing research, clinical development, PV/PPQ, commercialization, and lifecycle management.

• Lead strategic initiatives for emerging therapeutic platform technologies.

• Assess portfolio opportunities and propose development pathways, platform investments, and strategies for lifecycle expansion.

• Collaborate with Research, Translational Sciences, and Clinical Development to facilitate a smooth transition from discovery to development.

• Provide strategic oversight for manufacturing readiness, which includes process characterization, tech transfer, PV/PPQ, comparability, and supply chain readiness.

• Ensure alignment among Clinical Development, Manufacturing/MSAT & Supply, Quality, Regulatory, and Commercial teams for late-stage development and launch planning.

• Guide the commercialization strategy, focusing on launch readiness, market access, product differentiation, and lifecycle expansion.

• Collaborate with the Project Management lead to develop and oversee program timelines, action items, issues/risks, and budget management.

• Support governance decisions related to manufacturing strategy, CDMO partnerships, network design, capacity planning, and commercial supply.

• Work with Research, Translational Sciences, and Technical Development to promote next-generation therapeutic modalities and platform technologies.

• Ensure that development strategies align with platform-specific regulatory, manufacturing, clinical, and commercial considerations.

• Drive integrated multi-platform planning with an emphasis on portfolio value and risk mitigation.

• Lead cross-functional planning for INDs, BLAs, label expansions, post-marketing commitments, and global lifecycle management.

• Collaborate with third-party technology and/or development partners to advance programs and operational plans.

⛳️ Requirements

• PhD or advanced degree.

• 10+ years of experience in the bio/pharma industry as a program/LCL lead.

• Proven background in biologics and autoimmune/oncology/hematology.

• Comprehensive understanding of the pharmaceutical business model and value chain, particularly in a healthcare setting.

• Experience collaborating with research, clinical, and non-clinical development, or commercial partnerships with alliance partners.

• Demonstrated expertise in drug development across Research, Translational Sciences, Clinical, Manufacturing, Commercial, and Regulatory functions.

• Strong proficiency in clinical data with the ability to interpret complex data sets.

• Experience with NDA and BLA filings, as well as regulatory submissions across various lifecycle stages.

• Experience working in an international context.

• Proficiency in cross-functional drug development and clinical-stage program management.

• Understanding of the drivers for commercial success and stakeholder interactions among customers, patients, physicians, pathologists, regulators, and payers.

• Ability to initiate projects, resolve issues, preempt problems, and meet objectives.

• Capacity to multitask and promote objective outcomes in a resource-limited environment.

• Ability to work effectively and manage stakeholder relationships smoothly and efficiently.

• Capability to drive delivery and advance complex global programs through effective governance and targeted executive escalation within a matrix organization.

• Experience and skill in innovation, guiding teams to think creatively and deliver effectively.

• Proven judgment to identify, analyze, evaluate, escalate, and/or resolve issues impacting global program execution or financial outcomes.

• Excellent verbal and written communication skills, with persuasive and credible presentation abilities.

• Ability to address issues and conflicts constructively.

• Capacity to generate bold ideas and take calculated risks.

• Strong tolerance for ambiguity, agility to adapt to change, confidence to voice concerns, and the ability to challenge appropriately.

🏝️ Benefits

• Eligible for a bonus.

• Comprehensive benefits package.

• Participation in the Company’s stock plan.