Global Clinical Development 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. 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. Apply to learn more!
Remote working outside of listed locations may be considered for a limited number of qualified applicants by exception and where the needs of the individual and the business can both be met.
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 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.
- 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.
- 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 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
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.
- 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.
- Excellent leadership skills, 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 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.
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.
in R&D At GSK, we want to find new medicines and vaccines in ways that are faster, more effective and more predictable.
We start with what matters most, the science. Our approach to R&D focuses on science related to the immune system, the use of human genetics, and advanced technologies. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including oncology, infectious diseases, immunology / respiratory and HIV. We have pivotal study starts in 2021 for our RSV vaccine in older adults, COVID-19 assets, long-acting anti-IL-5 antagonist, daprodustat, and dostarlimab. In oncology, momentum is building with 15 potential medicines in trials, including nine immuno-oncology and three cell therapies.
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 most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere.
Technology can help us find patterns in genetic data better and faster. We’re using machine learning to unlock the potential of complex genetic data with new levels of speed, precision, and scale. And we’re one of the first biopharmaceutical companies to have created an in-house AI lab dedicated to drug development.
Even with the knowledge, tools, and resources within GSK, there’s always a benefit to new perspectives. Thats why were increasingly partnering with and hiring outstanding people from cutting edge fields like tech, data-science and academia. In 2018, GSK formed an exclusive, highly innovative collaboration with 23andMe, the worlds leading consumer genetics and research company. Other partners include: the Altius Institute; the UK Biobank, which is generating anonymized genetic sequence data from 500,000 volunteers; and the Open Targets Consortium, the mindset and approach of smaller, more agile startups.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, colour, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class
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.
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.