Us Director Of Clinical Operations Enablement (Remote)

Site Name: Home Worker - USA
Posted Date: Jul 10 2023
The Director of US Clinical Operations Enablement is accountable for the oversight, management, and leadership of the US GMASE operational support enabling functions including site budget and contracting team, finance, resourcing, performance metrics, business continuity, and clinical supplies. This role will matrix with internal and external stakeholders and ensure successful delivery of the clinical studies across all therapy areas in both pharma and vaccines. The individual in the role requires a high level of knowledge, experience and talent to well-represent GSK R&D within the local environment.
This role will provide you the opportunity to lead key activities to progress your career.
Job purpose and key responsibilities:

• Ability to lead a functionally diverse team, remotely.
• Available and willing to travel as job requires.
• Accountable for clinical operations staff that provide enabling support roles such as local finance, resourcing, and metrics tracking.
• Oversee the US Investigator budget and contracts team, providing oversight of country processes and tools related to budget development, site contracting and site payments.
• Responsible to identify and share best practices, standardizing across the LOC / region and representing local/regional clinical operations on global and cross functional initiatives. Represents study support on internal and cross functional process improvement teams and drives for process efficiencies to be embedded as a continuous improvement mindset way of working within the US, and influences global approaches where appropriate.
• Accountable to US Head for functional resource management and ensuring workload allocation is adequate so that studies are resourced appropriately, and capabilities are aligned with study requirements, resource availability and business priorities.
• Participate as a member of the US GMASE LT, representing these enabling operational activities, and inputting into the US GMASE strategy
• Effectively manages routine and complex issues and escalates appropriately.
• Responsible for recruitment, or leading efforts, for development of GSK permanent staff.
• Oversees delivery of planning and metric analyses reports/data for US LOC to identify trends, findings and ensuring impact to clinical business (resource, cost, productivity, performance to target metrics) and to support the development and delivery of strategic initiatives to reflect emerging business needs.
• Collaborates and communicates on key operational issues with matrix partners at the local, regional and global level as required.
• Collaborates with the relevant country and/or central teams for determining the feasibility of conducting protocols with reference to patient population, study complexity, and relevant resource. Maintains oversight of selection of suitable hospitals/clinics/investigators.
• Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities Serves as an expert in ICH GCP and GSK written standards.
• Accountable for Clinical Supplies Lead, who is the country subject matter expert knowledge of requirements for importation and distribution of supplies according to local regulations and manufacturer requirements, ensuring the necessary operational processes are in place.
• Manage key stakeholder relationships with Legal, Finance, and Study Delivery, ensuring budget, contract and payment outputs are timely, high quality and fit-for-purpose.
• In collaboration with Clinical Operation Head and Local/Regional Risk and Management Monitoring identifies management monitoring process checks linked with function activities that require inclusion in the local quality plan
• Accountable for Enablement staff, by providing study/GSK related training, coaching and mentoring for all staff. For internal staff this will include line and performance management, evaluating capabilities and competencies, and identifying and coordinating implementation of personal development plans.
• Assists with audits/inspections of local clinical operations department & study / sites in the country.
• Responsibility to engage with the FSP partner and ensure they deliver according to agreed timelines and quality expectations.
• Contributes to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilisation of resources and performance metrics. Engage with the DAP team where necessary.
• Supports the development and management of the US country IPE budget in collaboration with the country head

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

• Excellent leadership skills with demonstrated ability to build and maintain highly efficient and performing teams in complex environments.
• Stakeholder management skills required as the role includes interactions with senior stakeholders at a central or LOC level.
• Experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process.
• Excellent verbal and written communication, negotiation, presentations, and relationship skills to drive business performance.
• Bachelors Degree in Life Sciences required coupled with line and project management experience.
• 8+ years of relevant experience in the Pharmaceutical, Biotech or Healthcare Industry with an emphasis on vaccines/drug development, in a multidisciplinary environment, including a preference of previous line management experience.

Preferred Qualifications:

• Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment.
• Knowledge or ability to acquire expertise regarding use of multiple systems/tools related to clinical studies.
• Business acumen and demonstrated ability to think strategically, quickly appreciate the differing perspectives in a given situation and achieve a win-win outcome.
• Masters of Science, MBA, PMP, or equivalent

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.
Find out more:
Our approach to R&D
GSK offers a competitive compensation package inclusive of the following: Competitive base salary, annual bonus based on company performance, access to healthcare and wellbeing programs, retirement savings program, paid time off, and employee recognition programs which reward exceptional achievements. The salary range for this role is: $0 to $0
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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