Director, Clinical Operations Asset Lead
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assurancegcpbiostatisticsfdacroinformaws
Job description
Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Position Summary The Clinical Operations Asset Lead is the single point of accountability for clinical operations delivery across the full asset lifecycle. Representing Global Clinical Operations at the asset level, the COAL sets and delivers the program‑level operational strategy that enables execution of the scientific vision. Working in close partnership with clinical, biostatistics, and functional experts, the COAL drives informed decision‑making, provides strategic leadership to Study Delivery Teams, and ensures high‑quality, on‑time delivery—while retaining full accountability for overall asset outcomes. Key Responsibilities: Asset & Development Strategy Contribute to the Clinical Development Plan (CDP) and Integrated Evidence Plan (IEP) across Research, Development, and LCM Ensure study designs are operationally feasible, regionally compliant, cost‑effective, and deliver high‑quality data Provide protocol‑level operational input and support amendments through governance review Resourcing & Vendor Strategy Lead and own the asset‑level resourcing strategy (in‑house vs outsourced) Approve vendor selection, contracting, and oversight in line with GSK standards Delivery Quality & Inspection Readiness Serve as escalation point for critical operational, quality, and GCP issues Lead cross‑functional coordination to ensure inspection readiness and high‑quality study delivery Ensure transparent communication of risks, issues, and successes across GCO Operational Delivery & Governance Own asset‑level delivery plans, scenario modeling, and budget forecasts Drive innovative, patient‑centric and efficient approaches to study execution Represent Clinical Operations at governance boards and support clinical filing activities Risk, Data & Stakeholder Management Own the asset‑level risk register and mitigation strategy using Quality by Design Ensure accurate, current operational data in GSK systems until transition to study teams Lead internal and external stakeholder engagement across the asset Capabilities: Demonstrates conceptual, analytical and strategic thinking to innovative approaches to clinical delivery, leverage external technology and networks and build internal capability Ability to translate strategic concepts, scientific requirements, stakeholder feedback and expectations into cohesive actions for the Asset team Innovative and change adept whilst identifying and embracing risks as opportunities Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment, demonstrating conflict management and negotiation skills Partnering skills with key role such as clinical science, biostatistics and other subject matter experts (SME) at asset level to articulate and champion key decisions and strategy Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives Strong influencing and stakeholder management skills at all levels of the organization. Strong communication skills appropriate to the target audience, promoting effective decision-making Leadership style sensitive to different cultures and experience levels in a matrix environment to ensure appropriate asset operational delivery and optimally motivate individuals to reach their potential Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor’s degree in general science or life/health related Science Degree Extensive portfolio‑level strategic experience leading and delivering complex clinical research programs or equivalent initiatives with significant business impact. Expert‑level experience across end‑to‑end clinical development and the regulatory landscape, enabling proactive, innovative strategic guidance and independent leadership of complex cross‑functional teams. Proven experience navigating and strategizing across multiple regulatory pathways potentially pursued simultaneously for different indications. Ability to develop and execute integrated strategic plans across multiple streams and indications for one large asset or multiple interdependent assets Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives within highly complex and high-pressure environments, while maintaining visibility at a senior level. Excellent influencing and stakeholder management skills at all levels of the organization (including SVP and C-level). Competent in working with complexity and uncertainty within the external regulatory environment (e.g. FDA, EMEA) Preferred Qualifications: If you have the following characteristics, it would be a plus: Masters’s Degree in General Science or life/health related Science Degree or MBA Preferred experience leading or contributing to operational integration aspects of BD deals Demonstrated cross-functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization. #LI-GSK* Skills Analytical Thinking, Business Acumen, Change Management, Clinical Research, Clinical Trial Designs, Communication, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Risk Management, Strategic Thinking • If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $189,750 to $316,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experi
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