Test Ahamd VONQ

Global Clinical Development Associate Director

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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 a Clinical Operations Leader who has experience leading global paediatric oncology studies.  It’s a wonderful time to join our team in Immuno-Oncology. Apply to learn more!

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 paediatric 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 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/carer 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
• 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 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
• Provide expert clinical operational input into protocol development
• 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 paediatric patient councils, paediatric networks, and advisory groups to develop paediatric patient centric documents and address paediatric patient burden

Closing Date for Applications: 28th May 2023 (COB)

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’ 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
• Extensive clinical development experience with at least 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
• Experience managing paediatric oncology studies globally, through start up, maintenance and close out
• Experience in developing robust paediatric recruitment plans in a challenging patient population
• Proven operational experience of leading high performing global study teams in clinical trials
• Proactively identify and resolve issues to ensure timely study delivery to quality, timelines, and budget
• Excellent leadership skills, influencing and negotiation skills
• Demonstrated experience leading in the matrix environment to deliver projects, develop clinical plans and manage change
• Working knowledge of the paediatric regulatory environment
• In-depth knowledge of study management and knowledge of essential global regulatory guidelines and ICH/GCP
• Proven experience working with investigators, external experts and regulatory agencies and oversight of Contract Research Organizations 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
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
• Excellent project management skills and budget management skills
• Possess competent written skills and experienced in authoring patient facing materials, study procedures manuals, pharmacy manuals, and informed consent forms

Preferred Qualifications

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

• 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
• Experience working in full-service outsourcing (FSO) model

#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.

GSK is an equal opportunity employer committed to diversity and inclusion.  We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at canada-recruitment@gsk.com.  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.

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