Oncology Global Clinical Development Manager

Global Clinical Development Manager

GSK continues to expand its oncology organization, and we are looking for experienced professionals to help us grow our internal expertise! We have an exciting (and expanding) portfolio and are looking for Clinical Operations Leaders who have experience leading global oncology studies. It's a wonderful time to join our team because we have multiple open positions in the areas of Immuno-Oncology and Synthetic Lethality & Cancer Epigenetics.

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The Role:

Reporting to the Study Delivery Lead (Team) Director, this job within Global Clinical Delivery (GCD) combines end-to-end design, execution, and reporting of clinical trials with leadership in project teams and across matrix teams. This position within GCD is accountable for planning and leading the delivery of oncology studies to time, quality, budget, company standards and scientific requirements as outlined in the clinical study proposal.

This involves generating robust and accelerated delivery plans (with a focus on upper quartile performance) and delivering these to target or stretch thresholds.

The role may span oncology assets from early through to late phase of development and include delivery through one or more of in-house, outsourced and alliance delivery models. This role is highly visible within Global Clinical Operations.

Key attributes include demonstrated ability to input to and influence studies/projects through operational expertise and effective stakeholder management. This job requires strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change.

Essential behaviours include continuous improvement and learning, effectiveness at building networks of partners and stakeholders, and ability to lead and inspire others. A track record of applying experience and judgement towards agile project decision-making, effective peer review, and shared learning is essential.

Key Responsibilities:

• Lead the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc).
• Drive assessment, selection, engagement, and management of appropriate vendors.
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and GSK SOPs, for all products and services delivered for their designated studies.
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate.
• Actively partner to build relationships and collaborate with oncology aligned staff in other global functions.
• Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
• Lead the conduct of investigator meetings and other study related meetings.
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
• Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project budget allocation.
• Lead / contribute to ways of working and process improvement initiatives.
• Input into protocol development from a Clinical Operations perspective.
• Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study
• Actively partner to build relationships and collaborate with Oncology aligned staff in other global functions e.g., partnering with functional lines to deliver the Clinical Study Report.
• Work with the Oncology patient councils to develop patient centric documents and address patient burden.

When applying for this role, please use the 'cover letter' and your CV/resume to describe how you meet the skills and competencies for this role, as outlined in the job description above.

The information that you have provided in your cover letter and CV/resume will be used to assess your application.