Company Description

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening disease. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins of proteins as drug targets.

Position

We are currently seeking an experienced leader for the role of Senior Director Clinical Operations. The Senior Director will manage all aspects of clinical operations study management and be responsible for exquisite execution of all interventional clinical trials and oversight of Clinical Research Organization (CRO) run studies.

Adherence to Good Clinical Practice (GCP), local and global policies and procedures to conduct high quality, inspection ready studies is essential. The Senior Director is responsible for trial quality and audit responses and completion of CAPAs. The incumbent ensures a single point of contact for managing clinical trial execution in all its aspects across phases I/II through III/IV.

The position has multiple touch points with Research & Development (R&D) staff and important interactions with, inter alia, Quality Assurance (QA), Finance, Regulatory, Clinical Supplies, Business Development and Legal in a matrix-based organization.
What You’ll Do

• Provide leadership to Clinical Operations study management: Build the best team and chart the course. This includes continual optimization of the organizational design and resources, ownership and optimization of key processes, talent and succession management, overall operating budget management and oversight of all high priority programs and studies.
• Manage Clinical Operations activities and study management personnel. Ensure that compliance, quality and timeline objectives are met for all trials executed globally.
• Work collaboratively in a matrix organization with all internal stakeholders to deliver objectives on time, on budget and with high quality.
• Collaborate with Functional Service Provider (FSP), as necessary, to ensure adequate and appropriate resourcing for our company’s internal clinical trial portfolio.
• Collaborate with clinical vendors, including CRO senior, regional and local leadership to ensure the successful implementation of fully outsourced clinical trials.
• Work with the R&D Therapy Area leads, as appropriate, in site management and selection decisions.
• Support the development and management of Investigator relationships in conjunction with the R&D Therapy Areas. Contribute to the program life-cycle management through effective study allocation and execution (prioritizing programs, working with KOLs, etc.).
• Take responsibility for any clinical audits, working closely with the QA group.
• Represent Clinical Operations Study Management in strategic initiatives at all levels of the organization.
• Build and execute strategies for patient enrollment to include sourcing, selecting, contracting, and oversight of clinical vendors related to patient recruitment and retention.
• Effectively solve problems and use judgment relating to national and international regulations, guidelines, investigator interactions and timelines.
• Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the portfolio and achieve R&D objectives. Responsible for ensuring appropriate scientific and operational training for staff members.
• Will drive top quartile performance via implementation of novel partnerships, site networks, cooperative groups and clinical operations industry best practices.
• Contribute to ongoing department infrastructure development efforts such as SOP development, implementation and/or innovation of new processes and clinical system capabilities to consistently deliver operational excellence.
• Serve as a talent magnet and develop, coach, and retain top talent in the team. Set clear performance standards and holds self and organization accountable for achieving results. Embraces metrics and performance standards (KPI’s).

Qualifications

• Master’s degree in a life science, or equivalent, combined with a proven track record of contribution to and delivery of clinical trials that support global regulatory submissions, clean regulatory inspections and product approvals or marketing authorizations.
• 10 years of experience in Clinical Trial Operations gained from working at hospitals and/or research institutions, recognized clinical trial suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
• Significant management experience in a clinical trial setting with the ability to service and collaborate with different R&D stakeholders in a matrix organization.
• Management expertise should cover management of budget, resources, headcount, processes (and controls), productivity, quality and project delivery.
• A complete understanding of ICH GCP and Global/Regional/Local regulatory requirements is required.
• Strong communication skills requiring proficiency in written and spoken English. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking and high emotional intelligence.
• Strong leadership that will attract, motivate, inspire, develop and retain talented staff. In addition, leadership skills that enable and drive alignment with the goals, purpose and mission or our company.