Global Trial Delivery Lead - Sponsor Dedicated

ph3Trial Delivery Leader (TDL) /h3 pThe bTrial Delivery Leader (TDL) /b serves as the single point of accountability for trial operational strategy, trial‑level budget, quality, and on‑time delivery of assigned clinical trials. This role represents the evolution of the Global Trial Leader (GTL), with a stronger emphasis on strategic leadership, end‑to‑end accountability, and governance‑level decision making. /p pThe TDL works in close partnership with the Program Delivery Leader (PDL) and co‑leads the Cross‑Functional Trial Team (CFTT) to ensure trial strategies are aligned with program objectives and executed efficiently. /p pThe Trial Delivery Leader plays a critical role in ensuring clinical trials are delivered efficiently, compliantly, and with high quality, while balancing speed, cost, and innovation. /p h3Scope of Focus /h3 ul liCo‑leading the CFTT and driving cross‑functional alignment /li liCoordinating functional strategies (e.g., trial endpoints, ARBM, biomarkers, DEICT, digital health, companion diagnostics) /li liEnsuring timely delivery of trial‑level deliverables /li liTrial‑level budget ownership and oversight /li liQuality oversight and inspection readiness /li liEarly operational input during initial protocol development /li liDevelopment of cost‑optimized and accelerated scenarios and innovative approaches, aligned with trial tiering (post‑POC) /li /ul h3Key Accountabilities /h3 ul liDevelop the trial operational strategy, integrating and aligning all trial‑level functional strategies into a single, holistic approach, including vendor strategy. /li liPartner closely with the PDL to shape trial‑level strategy in alignment with overall program strategy. /li liCo‑lead the Cross‑Functional Trial Team (CFTT), setting meeting cadence, agendas, and expectations. /li liEmpower CFTT members to independently drive their functional deliverables while maintaining accountability for timelines and quality. /li liServe as the single point of accountability for on‑time delivery, quality, and trial‑level budget across assigned trials. /li liEnsure all trial milestones, quality targets, and budget commitments are met. /li liProvide budget management and oversight at the trial level, including scenario planning and cost optimization. /li liReview and approve key study‑level documents (e.g., global master ICFs). /li liProactively identify, assess, and mitigate trial‑level risks, overseeing them through to closure. /li liDefine protocol deviation and resolution pathways. /li liTake ownership of study‑level escalations, including vendor performance issues and enrollment risks. /li liCommunicate trial risks, issues, changes, and milestones to relevant stakeholders in a timely and transparent manner. /li liRepresent Global Development (GD) at trial‑level therapeutic area (TA) governance forums. /li liContribute to and influence governance decisions, ensuring operational feasibility and alignment. /li liAttend Clinical Team (CT) meetings when requested by the PDL. /li liEnsure strong alignment with key stakeholders on protocol amendments, enrollment targets, and study changes. /li liEnsure all trial operational activities, TMF, and study documentation are health authority‑compliant, inspection‑ready, and meet required quality standards at all times. /li liSet up and oversee clinical trial systems and documentation, including (but not limited to): E7 drivers, Safety Management Plan, JJAR Unified Clinical Trial Team (UCT) setup. /li /ul h3Candidate Profile – Requirements /h3 ul liBachelor’s degree (BS) or equivalent in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy) /li li6–8 years of clinical trial management experience within the pharmaceutical industry or a CRO, including specific therapeutic area experience /li liProven experience managing clinical trials end to end, from start‑up through database lock and trial close‑out /li liStrong working knowledge of ICH‑GCP, local laws, and regulatory requirements /li liSuperior clinical research operational knowledge with a demonstrated track record of delivery /li liAbility to ensure ongoing quality, compliance, and inspection readiness /li liDemonstrated effective leadership, with the ability to proactively guide study teams through key trial stages /li liProven ability to delegate effectively while maintaining accountability /liliExperience leading teams from formation to high‑performance /li liStrong capability to manage multiple global stakeholders and cross‑functional partners /li liProven experience coordinating global or regional teams in a virtual environment, for a minimum of 2 years (preferably 3+) /li liAbility to foster team productivity, alignment, and cohesiveness across geographies /li liStrong project planning and project management capabilities /li liProven experience in proactive planning, risk identification, and mitigation throughout the trial lifecycle /li liAbility to gain team consensus on updated plans during changing project circumstances /li liDemonstrated capacity for independent, complex decision making /li liSolution‑oriented mindset with strong problem‑solving skills /li liStrong IT skills, including proficiency with Microsoft applications and familiarity with Trial Master File (TMF) Trial Management Systems (CTMS) /li liWillingness and ability to learn new systems and technologies /li liMonitoring experience is recommended; other relevant experience (e.g., data management or central monitoring) will be considered /li liExcellent verbal and written communication skills, supporting effective collaboration /li liProven experience developing presentations and presenting complex information to stakeholders /li liStrong analytical skills, with the ability to manage ambiguity when limited information is available /li liAbility to understand, plan, and oversee country‑ and vendor‑level budgets /li liAwareness of country Out‑of‑Pocket (OOP) cost drivers and FTE‑related cost components /li liWillingness to travel, as required /li liProficiency in English (spoken and written) and the local country language, as applicable /li liThis role is not eligible for UK visa sponsorship /li /ul /p #J-18808-Ljbffr