Bachelor's degree: life sciences or related discipline
Highly experienced strategic leader capable of performing study accountable role in an autonomous way across multiple studies or a single large / complex study.
Has depth and breadth of experience in clinical delivery, across indications, assets, phases, regions, etc.
Extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
Proven operational experience of leading high performing global study teams in clinical trials.
Demonstrated experience leading in the matrix environment to drive decisions, deliver projects, develop clinical plans and manage change.
In-depth knowledge of study management and knowledge of essential global regulatory guidelines and ICH/GCP.
Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.
Excellent project management skills and budget management skills.
In-depth experience in strategic leadership of innovative trial design including (but not limited to) adaptive designs and decentralised trials (DCT) design, with the learning agility to lead other/more complex innovative trial designs such as platform/umbrella/basket.
Very strong TA experience; where possible consolidated to specific areas / indications.
