Nom du site: Mississauga Milverton Drive
Date de publication: Oct 23 2024
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Study Delivery Lead Associate Director
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.
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 and in the Clinical Matrix Teams.
Key attributes include: demonstrated ability to input to and influence studies/projects through operational expertise and demonstrated excellence in stakeholder management. This job requires competent strategic thinking, solution-finding, and agility as evidenced by flexibility, adaptability to change, curiosity, and ability to lead and drive change.
Essential behaviours include: proven global leadership, 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,
Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc) and for overall study deliverables.
Drive assessment, selection, engagement, management, and oversight 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.
Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation
Preparation of materials for governance and / or financial review cycles and provide expert clinical operational input into protocol development.
Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary.
Identify and communicate resource gaps for assigned studies.
Lead risk management and quality efforts to ensure study compliance and continual inspection readiness.
Lead / contribute to ways of working and process improvement initiatives. Encourage others within matrix and line teams to seek alternative perspectives and develop solutions.
Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study and collaborate with Oncology aligned staff in global functions to deliver the Clinical Study Report.
Work with the Oncology patient councils to develop patient centric documents and address patient burden.
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.
Extensive clinical development experience that is equivalent to 6 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.
Proven operational experience leading global oncology clinical trials and knowledge of essential global regulatory guidelines and ICH/GCP.
Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget.
Proven leadership skills, influencing and negotiation skills.
Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change.
Preferred Qualifications
If you have the following characteristics, it would be a plus:
Oncology phase III global registrational study leadership experience.
Proven clinical development experience across all phases of development (I-IV).
Experience of innovative trial design (platform, basket, umbrella, adaptive designs) and decentralised trials (DCT) initiatives.
Highly developed communication skills appropriate to the target audience, promoting effective decision-making where necessary and ability to manage conflict.
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.
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.
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