Global Study Lead - FSP Team

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Global Study Lead (GSL) Department: Global Clinical Study Delivery (GCSD), Global Clinical Operations

Job Purpose:

This position within GCSD is accountable for leading the operational strategy, planning and delivery of the study/studies end to end from CSI (Commit to Study Initiation) until study archiving to time, quality, budget, company standards and scientific requirements as outlined in the clinical development plan. The GSL owns the vision for study success, the prioritization of deliverables and formation of Working Groups with key leadership across the matrix organization with the Study Level Statistician and Clinical Lead. The GSL represents Clinical Operations within the Study Leadership Team (SLT).

Key responsibilities include, but are not limited to:

• GSL will be a member of the Study Leadership Team (SLT) with accountability for the strategic leadership and delivery of clinical study/studies to time, quality, and budget, company standards and scientific requirements, driving decision making at pace and strategically leading study team to achieve overall study deliverables.

• Provide oversight and support (where needed) to the GSM and SM (as appropriate) on end-to-end clinical study delivery. Serves as the point of escalation for Clinical Operations.

• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs for assigned studies. understand study contribution to program/submission

• Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead.

• Balance risk/benefit to make decisions based on clear understanding of impact on the study and project.

• As the SLT escalation point for clinical operations, support the Working Groups leads to proactively and effectively identify, oversee, and mitigate study risks.

• Ensure appropriate stakeholder communication, including study status, expectations, risks and issues.

• Ensure robustness in upfront feasibility and planning.

• Preparation of materials for governance and / or financial review cycles.

• Accountable for the study budget.

• Effectively build and lead empowered matrix teams.

• Implement innovative approaches to study delivery through external facing advances in technology and sciences and encourage others within matrix and line teams to seek innovative perspectives and develop solutions in collaboration with the GSM and SM.

• Decision maker for the innovative solutions (e.g. DCT) to be used at study level.

• Provide strategic oversight on operational input into protocol and informed consent form development, and other key study documents.

• Ambassadors in increasing utilisation of AIML tools, driving automation of manual processes, finding efficiencies and more effective ways of working.

• Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.

• Lead / contribute to ways of working and process improvement initiatives.

• Provides therapeutic area expertise to support operations.

• Escalation point for vendor issues.

• Leads assessment and selection of FSO vendors in collaboration with COAL.

• Accountable for holistic oversight of FSO vendors according to the FSO handbook in collaboration with GSM and SM.

• Accountable for assessment and selection of other study vendors under GCSD responsibility in collaboration with GSM and SM.

Education Requirements (minimum expected):

Bachelor's degree: life sciences or related discipline The role will require a good understanding of complex clinical development and regulatory processes.

Job Related Experience (minimum requirements):

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. This level of experience is required to provide clinical trials and project management expertise as well as adequate leadership.

Other Job-Related Skills:

• 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. Able to drive decision-making at pace and strategically lead study team in an autonomous way to achieve overall study deliverables in complex and high pressure environments.

• Ability to influence and manage stakeholders at senior director and/or VP level.

• Ability to translate strategic concepts, stakeholder feedback and requirements into cohesive actions for the study team.

• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.

• Excellent leadership skills, influencing and negotiation skills.

• 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.

• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.

• 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.

• Highly developed communication skills appropriate to the target audience, promoting effective decision making where necessary and ability to manage conflict.

• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting crossfunctional matrix teams.

• Creative thinker able to modernize approach to clinical delivery, leverage external technology and networks to deliver value.

• Ability to articulate and champion key decisions and strategy.

• Ability to define value-driven vision and roadmap for the study.

• Ability to effectively prioritize activities and stakeholder needs.

• Makes timely and complex decisions based on strong rationale.

• Very strong TA experience; where possible consolidated to specific areas / indications.

• Growth Mindset and Mental Agility: Ability to work across various therapeutic areas and manage different types of studies effectively.

• Ability to connect people with our purpose.

• Ability to create psychological safety.

• Ability to foster collaboration and to empower others.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.