City : 7333 Mississauga Road North

Category : Other

Industry : Healthcare

Employer : GSK

Clinical Operations Planning Director

As R&D efforts follow science without constraint, we need to take full advantage of our internal data and expertise, as well as leverage external services and technology, to inform, optimize and validate our clinical trial protocols and study delivery plans. This includes the management of a robust site feasibility process.

As such we are seeking to appoint a Clinical Operations Planning Director/Associate Director to create data driven, high quality insights and modelling to support clinical operations project and study team members. This role will manage a team of Clinical Operations Planning Analysts and will also directly support clinical operations planning activities.

Key Responsibilities include, but are not limited to: 

·         Use internal and industry data sources, along with data analytics, to generate insights used for the planning of clinical trials

·         Utilisation of current and emerging data sources to identify risks and challenges to optimise clinical trial protocol design

·         Lead the site feasibility process in close partnership with the network of local offices

·         Provide timely, high-quality deliverables (e.g. recruitment plans, feasibility report) to clinical trial teams to support the clinical trial planning

·         Actively participate in team meetings to obtain relevant information and present the result of their work

·         Comprehensive tracking of assumptions used to generate deliverables 

·         Line management of a team of analysts: recruitment, objective setting, performance review, development, and resources tracking & management

·         Contribute to the tracking and reporting of KPIs and OKRs

·         Drive continuous improvement in Feasibility and Clinical Operations Planning processes

·         Identify and share trial informatics best practice and exemplars within Clinical Operations. 

·         May support the assessment, piloting and embedding of new data analytics and data sources to ensure GSK continues to access best in class solutions.

·         May act as Subject Matter Expert or System Business Owner for tools and systems

·         Maintain information on impact and successes. 

·         Provide mentoring and coaching to more junior members of staff

Basic Qualifications: 

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

·         Bachelor’s degree in relevant field

·         7+ years relevant industry experience 

·         Demonstrated leadership in a clinical development operations or study feasibility role at a CRO, pharmaceutical company or other relevant environment

·         Proven track record in problem solving

·         Excellent project management skills gained in a complex matrix organization

·         Results orientated with a drive to set and reach challenging goals with high standards for performance

·         Excellent influencing and negotiation skills

·         Excellent written and verbal communication skills 

·         Ability to build strong relationships

·         Ability to analyse data from divergent sources and translate it into meaningful recommendations

·         Good understanding of the drug development process

·         Understanding of all relevant industry guidelines (ie; FDA, GCP and ICH guidelines)

Preferred skills: 

·         Master’s or PhD degree in relevant field

·         Line management experience

·         Knowledge of Agile methodology

·         Experience utilizing clinical trial recruitment modelling tools  

·         Experience utilizing industry clinical trial related data sources (i.e., CiteLine, DQS, TriNetX, etc)

·         Experience across therapeutic areas would be advantageous 

·         Experience with data manipulation, visualization, or advanced analytics

·         High level of proficiency with Microsoft Office

Why GSK?

We’re uniting science, technology and talent to make a difference in more people’s lives, and revolutionising the way we do R&D.

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.

No single scientist, nor any one technology can keep us all ahead of disease. That’s why we build important collaborations with commercial and academic partners to advance our understanding of disease and what it takes to get ahead. In the past three years, we’ve doubled the number of partnerships we’ve signed, because of our belief in their significant impact on our process.

Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we’ve delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.

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.

We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do the most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.

Find out more:

Our approach to R&D.   

#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 impact the health of 2.5 billion people around the world in the next 10 years.

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.

Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices. In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors’ offices and dentists’ offices will need to be fully vaccinated against COVID-19.  Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.