Senior Manager, Clinical Trials Strategy & Submissions at AbbVie · LumiJobs

Responsibilities

Develop and lead the strategy and execution of a portfolio of Clinical Trial Applications (CTAs) including increasingly complex trial designs with elevated regulatory risk, involving high-priority assets, new therapeutic areas, adaptive trial designs, decentralized models, and evolving regulatory requirements.
Develop agile regulatory strategies that include risk assessment and actionable mitigation measures, provide strategic advice on submission planning to drive acceleration and successful execution of global CTAs across multiple markets.
Design and implement global CTA submission strategy that aligns with the overarching regulatory strategy and region-specific requirements and ensure that risks and issues are highlighted to the Global Regulatory Project Team (GRPT), study teams and functional leadership.
Lead CTA-specific scientific-advice procedures, advising study teams and management on available options and the optimal timing and approach for their use.
Assess scientific data against CTA regulatory requirements; identify gaps, develop mitigations, and lead resolution and escalation of complex regulatory or feasibility and operational issues.
Define country and regional strategies (geostrategy) based on regulatory expertise, country-specific trends and risk outlook, and acceleration opportunities. Serve as the EU Agency Point of Contact (APOC) for EU CTR submissions, leading regulatory-agency interactions, negotiations, and relationship building.
Lead discussions with and adapt the expertise and knowledge from senior leaders, including Therapeutic Area Vice-President (TA VP) Heads, Executive Medical Directors (MDs), etc., to shape the optimal regulatory strategy. Effectively frames complex issues for decision-makers. Prepares and delivers effective management presentations that lead to actionable results.
Make well-informed and strategic decisions that may impact clinical R&D deliverables on key geographic areas such as program timelines and quality, company reputation and credibility with regulatory agencies, downstream registrations, marketing authorisations, and market access outcomes.
Lead review and provide regulatory input on clinical trial submission-related documents, such as the Investigator’s Brochure (IB) and Clinical Study Protocols, managed by other functions to ensure alignment with regulatory compliance, emerging regulatory trends and expectations across regions and countries.
Serve as the Clinical Trial Submission & Strategy subject matter expert in cross-functional forums and study teams, acting as a key liaison with global and affiliate stakeholders to influence decisions and align strategy across functions. Educate stakeholders across therapeutic areas and programmes on regulatory requirements, risks and mitigations, timelines, strategies, and insights from trends in regulatory agency questions and requests for information (RFIs), while managing cross-functional expectations.
Ensure approved company CTA processes and regulatory SOPs are followed, and deliverables are completed within agreed timelines. Ensure compliance with current clinical trial legislation including EU CTR, IVDR, MDR, etc.
Monitor and track key project milestones (actual vs. planned activities and timelines), identify issues and changes to assigned stakeholders and communicate updates to management in line with company procedures.

Senior Manager, Clinical Trials Strategy & Submissions

Responsibilities

Benefits

Company

AbbVie

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