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 Study Delivery Lead (SDL) positions in the areas of Immuno-Oncology. Apply to learn more!

These are office based roles (hybrid onsite 2-3 days per week) based at either our Waltham, MA or Upper Providence, PA locations.

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.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in life sciences or related discipline.
• Considerable clinical development experience with at least 3 years as a global study leader with proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment.
• Three or more years of experience working with investigators, external experts and regulatory agencies and effective oversight of Contract research Organisations and third-party vendors including realigning with CRO partners when deliverables are at risk, negotiating solutions and leading After Action Reviews to share lessons learned.

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Proven clinical development experience across all phases of development (I-IV).
• Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary.
• Proven expertise in the proactive identification of issues which may impact clinical programs coupled with the ability to contribute to solutions affecting cross-functional matrix teams.
• Creative thinker able to modernise approach to clinical delivery, leverage external technology and networks to deliver value.
• Proven operational experience of leading high performing global study teams in Oncology clinical trials.
• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
• Strong leadership, influencing and negotiation skills.
• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.
• In-depth knowledge of either study management or data management, and knowledge of essential regulatory guidelines and ICH/GCP.
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment.
• Excellent project and budget management skills; review vendor invoices and drive the tracking of spend against approved budget.
• Possess competent written skills and experienced in authoring patient facing materials, study procedures manuals, pharmacy manuals, and informed consent forms.

Why GSK?

We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

#LI-GSK

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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