US Director of Clinical Operations Enablement

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:

• 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. 
• 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.
• 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.
• Supports the development and management of the US country IPE budget in collaboration with the country head
• Oversee the US Investigator budget and contracts team, providing oversight of country processes and tools related to budget development, site contracting and site payments.
• Manage key stakeholder relationships with Legal, Finance, and Study Delivery, ensuring budget, contract and payment outputs are timely, high quality and fit-for-purpose.
• 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.
• Accountable for clinical operations staff that provide enabling support roles such as local finance, resourcing, and metrics tracking.
• 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.
• Assists with audits/inspections of local clinical operations department & study / sites in the country.
• Responsible for recruitment, or leading efforts, for development of GSK permanent staff.
• 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.
• 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.     
• Responsibility to engage with the FSP partner and ensure they deliver according to agreed timelines and quality expectations.
• 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
• 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.
• Collaborates and communicates on key operational issues with matrix partners at the local, regional and global level as required.
• 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.
• Available and willing to travel as job requires.
• Ability to lead a functionally diverse team, remotely.

 Why you?

Basic Qualifications:

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

• 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.
• Experience in all stages of study lifecycle (start-up,  recruitment  and close out) and understanding of R&D and drug/vaccine development process. 
• Stakeholder management skills required as the role includes interactions with senior stakeholders at a central or LOC level.
• Excellent leadership skills with demonstrated ability to build and  maintain highly efficient and performing teams in complex environments. 
• Excellent verbal and written communication, negotiation, presentations, and relationship skills to drive business performance.

Preferred Qualifications:

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