Job Description

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Position: Associate Director, Regional Delivery Lead (RDL)

Position Summary:

The Associate Director, Regional Delivery Lead (RDL) is a project leader that helps drive accountability and delivery of all country clinical operations team commitments within a region (e.g., Americas, EMEA, APAC, etc.) for assigned trials throughout the end-to-end study lifecycle by coordinating between global and local teams. The RDL directly works with Global Trial Managers, Clinical Trial Managers and Regional Clinical Operations country leadership in countries within their region to support delivery of multiple trials. The Associate Director, Regional Delivery Lead is someone who is passionate for coordination, experienced in country/regional clinical trial delivery, able to implement strategic solutions and demonstrates strong communication and leadership skills.

• Drives the clinical trial feasibility process and decision-making for country, site, and patient allocations on behalf of a region in collaboration with global and country operational leaders
• Monitors and drives country-level timeline planning and sequencing of events in assigned region during study start-up within a region
• Synthesizes learnings from trends surfaced from regional monitoring throughout study conduct and leads patient re-allocation decisions as needed

• Leads decision making for allocation of countries, sites and patients for insourced clinical trials in collaboration with global and country study leadership

• Drives the country- and site-feasibility processes within assigned regions
• Communicates country perspectives on study feasibility to facilitate effective planning and assumptions when establishing milestones for a trial
• Monitors country progress during feasibility and escalates concerns to the global team
• Ensures that relevant stakeholders are proactively notified of key feasibility decisions

• Oversees country-level timeline planning and drives inputs for the global team to holistically sequence events; ensures adherence to timelines and pushes teams towards mass site activation
• Synthesizes regional challenges and shares with global study team for early mitigation; pressure tests mitigation strategies to be employed to overcome challenges
• Oversees regional progress towards delivery of key documents for regulatory/HA submission, and communicates delays across stakeholders
• Communicates bi-directionally between global and local stakeholders to support clinical trial delivery
• Coordinates and tracks progress towards site activation goals including clearing bottlenecks and flagging delays at a regional level
• Drives local accountability and momentum towards key milestones

• Monitors country and regional trends in enrollment and execution; Synthesizes trends and patterns for leadership consumption
• Monitors patient enrollment across countries to identify regional patterns and inform global study team when reallocation is warranted
• Ensures proper oversight and accountability on key data metrics through database lock
• Performs country-level storyboarding

• Proactively develops and maintains collaborative relationships with global and local stakeholders on multidisciplinary teams across leadership levels within the organization
• Ensures appropriate methods are used when communicating with key stakeholders and cross-functional partners

• Effectively influences and communicates with individuals at all levels of the organization between global and local teams including situations of conflict resolution, problem solving and crisis management
• Creates and monitors realistic regional plans that clearly define goals, milestones, responsibilities, and results
• Leads regular meetings with Clinical Trial Managers within region, and contributes to meetings with the global team
• Holds self and others accountable by proactively communicating with key stakeholders and global/local teams, making timely and data-driven decisions while considering global and regional perspectives
• Prioritizes work and shifts priorities as needed, builds relationships and collaborates across teams, functions and geographies
• Focuses on delivering the strategic and corporate objectives while accomplishing operational goals

• Effectively manages multiple assigned trials at a given time and sets priorities with minimal guidance
• Understands interdependencies and effectively escalate issues with proposed solutions to appropriate global team in a timely manner
• Understands the upstream and downstream implications of decisions that affect study and regional outcomes and timelines; proactively communicates the implications with a proposed solution to the appropriate stakeholders
• Ability to focus on country level and study level work as situations arise and deliver high quality presentations to key stakeholders
• Proactively provides recommendations and perspectives when seeking guidance from GTMs and/or other global team members

• Acts as a mentor to local team members

• BA/BS or equivalent degree in relevant discipline

• Minimum of 7 to 10 10 years of project management experience in the pharmaceutical industry in country or regional operations required
• Experience in leading multi-functional teams
• Demonstrated project leadership, management, and organizational skills with strong presentation and communication abilities
• Experience with electronic quality, compliance, and CTMS systems required
• Risk management experience is preferred

• Clinical trial project management skills at a country or regional level with strong presentation and communication abilities
• Strong experience in the areas of feasibility processes (study, country and site), first in human trials, pediatrics, cell-therapy or neurology is sought after and will hold the candidate in an advantaged position.
• Financial budgeting, forecasting, and feasibility expertise are a plus
• In depth knowledge of regulatory guidelines, drug development and clinical research processes in country and/or region
• Proven success in using oral/written communication skills to influence, inform, or guide others
• Computer skills - Microsoft applications including (but not limited to), Word and Excel and PowerPoint
• Proficiency in study tools including electronic system skills (e.g., CTMS, eTMF)
• Ability to manage multiple deliverables and nimbly respond to changing business demands

• Up to 25% of travel required based on study needs