Director, Clinical Operations Program Leadership

Leads the development and ongoing refinement of program level study timelines and scenarios in order to contribute to the Integrated Asset Plan (IAP) and other high-level strategic plans

Provide rigorous, objective information (status and updates) and aligned QSDO recommendations to DAT to support strategic project decisions

Takes overall accountability for QSDO delivery of the clinical studies within a program and provides appropriate oversight to ensure a high quality, ethical, cost-efficient way to meet governance approved timelines and patient recruitment goals

Ability to learn and adapt to the organizational governance framework and associated processes

Accountable to lead the COPL input and development of governance presentations and/or memos including integration of the operational voice

Ability to engage/communicate key messages, including risks, to senior and executive level functional leaders outside of QSDO

Ability to reach technical alignment on governance materials with the Head of QSDO and Head of CTDU in accordance with associated governance timelines

Engage proactively with Biogen and partner stakeholders (e.g. CROs, vendors) and appropriately leverage QSDO governance to support clinical program execution

Responsible for escalating CRO/FSP, vendor delivery issues to senior leadership at vendor partner level, driving delivery of risk mitigation strategies to maintain and deliver program timelines

Responsible for the development and execution of a QSDO Program Operational Plan (POP) accounting for the therapeutic area and underlying science and opportunities for innovation and operational consistency as well as the future clinical, regulatory, and commercial development plan for the molecule

Proactively integrates stage-appropriate needs into operational strategy

Cascades the POP within QSDO to appropriate sub functions to establish vision and strategic framework for successfully delivery at the study level and with individual areas of technical expertise

May participate as a functional contributor to due diligence/business evaluations including the review of external CDP and strategy, the development of internal timelines, scenarios and recommendations, the review of external capabilities and the development of QSDO resource plans for potential new clinical candidates

• Undergraduate degree in a scientific or health-related discipline
• Advanced scientific or business degree or equivalent experience (MS/PhD/PharmD/MBA/MPH) preferred
• Minimum of 12 years’ experience within a Biotech/Pharma environment in drug development, clinical research, and operational strategy experience, ensuring studies and programs are executed to quality, timelines, and budget
• At least 3 years of this time in a Biotech/Pharma Program Operational Delivery capacity is required
• Demonstration of project/program management skills including risk assessment and identification of mitigations, timeline and budget management, and contingency planning
• Demonstration of effective team leadership and an ability to effectively influence matrix teams
• Excellent communication, time management, and organizational skills, along with problem solving, conflict resolution, and team building skills
• Experience identifying and leveraging relevant data and information to develop well-conceived and executable timelines
• Experience across several complex therapeutic areas
• Scientifically and clinically agile, proven ability to learn and apply relevant disease information into strategic operational planning and delivery
• Deep operational expertise
• Experience planning and delivering global clinical programs and studies through all stages of development Ph 1-4 and LCM
• Experience facilitating the development of Clinical Development Plans (CDPs) with multiple functions strongly desired.

Demonstrates extensive experience in drug development and clinical research within the Biotech/Pharma industry, with a strong focus on program operational delivery, project management, and strategic planning. Proven ability to lead cross-functional teams, communicate effectively with senior leadership, and develop executable timelines for clinical…