Associate Director, Clinical Trial Management/Local Delivery Lead

GSK • Philadelphia, PA

8d

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D

Position Summary
Would you like to be part of GSK’s emerging clinical leadership, with an opportunity to accelerate clinical operations on a national scale? If so, this could be an excellent opportunity to explore.
The Associate Director, Clinical Trial Management/Local Delivery Lead provides leadership, oversight and manages the activities of operational planning and delivery of Phase I-IV Medicines clinical trials in the United States to the required quality standards, GSK written standards, local regulations and ICH GCP. In a senior capacity, act as a role model, coach, mentor for less experienced LDLs on processes, technical and behavioral competencies.
Key Responsibilities:
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following.
Leads the local study team consisting of US clinical operations team members, cross functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the United States.
Serves as the operational point-of-contact between the central GSK study team and US study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements
Accountable for delivery of assigned studies to recruitment targets, diversity targets, time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH guidelines, GSK Corporate, and local SOPS and POLs.
Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.
Ensures that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for US team to ensure productive, efficient study delivery.
Has the curiosity to understand the why and the courage to challenge the how.
Acquires and maintains an appropriate level of knowledge on the study compound, protocol, study indication(s), pathology of disease area being studied, competitive landscape within the US, local treatment/immunization guidelines and local health care system requirements.
Can lead and influence a matrixed team of stakeholders to ensure successful study execution.
Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
Identifies and resolves or escalates issues and risks that may impact study delivery. Takes a leadership role in identifying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level.
Provides feedback on performance, capabilities and competencies of study members to line management.
Ensures appropriate site monitoring activities have been completed per the study monitoring plan and reviews/ approves monitoring visit reports.
Accountable to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
As required, advises on contract development with Sites/CRO/Vendors and participates in budget/contract negotiations with study vendors or clinical investigator sites.
As required, assists with audits/inspections of local clinical operations department and study / sites in the US.
Takes a leadership role in standardizing processes, identifying and sharing best practices in support of continuous improvement. Represents local/regional clinical operations on global and cross functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally.
Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards.
Acts as a role model, coach, mentor for less experienced LDLs on processes, study, technical and behavioral competencies. Provides training for new and less experienced LDLs as required.
Available and willing to travel as job requires.

Requirements

• Bachelor’s degree: BA or BS
• At least 7 years’ experience as a clinical trial manager/local delivery lead managing studies and at least 4 of the years managing Medicines trials.
• Must have Phase I-III Medicines trial experience in Oncology and/or Respiratory, including dose escalation and dose expansion studies for various indications.
• Must have experience with leading and managing multiple complex design studies. This can, but is not limited to, master protocols of umbrella, basket and platform trial designs.

Nice To Haves

• Master of Science, PhD or equivalent coupled with previous project management experience.
• Experience in clinical development or equivalent experience in the pharmaceutical or health-related field.
• Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug development process.
• Effective problem solving, negotiation and conflict resolution skills in a matrix environment
• Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
• Strong written and verbal communications skills are required in English
• Strong planning and organizational skills, with the ability to work efficiently and effectively in a dynamic environment. Works in an environment that is constantly evolving with new processes and systems, internally and externally and adapts to these changes quickly and efficiently.
• Demonstrates track record in quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. Recognizes potential risks and can implement effective mitigation strategies.
• Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.
• Strong project management skills; comfortable projecting, managing, and reporting budget information (business and financial acumen) and able to develop scenarios and effective contingency plans.
• Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies.
• Deep knowledge of human research regulations in the US, IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines

Responsibilities

• Leads the local study team consisting of US clinical operations team members, cross functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the United States.
• Serves as the operational point-of-contact between the central GSK study team and US study team. The LDL collaborates closely with local medical and regulatory affairs staff to align local medical and scientific requirements
• Accountable for delivery of assigned studies to recruitment targets, diversity targets, time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH guidelines, GSK Corporate, and local SOPS and POLs.
• Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.
• Ensures that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for US team to ensure productive, efficient study delivery.
• Has the curiosity to understand the why and the courage to challenge the how.
• Acquires and maintains an appropriate level of knowledge on the study compound, protocol, study indication(s), pathology of disease area being studied, competitive landscape within the US, local treatment/immunization guidelines and local health care system requirements.
• Can lead and influence a matrixed team of stakeholders to ensure successful study execution.
• Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
• Identifies and resolves or escalates issues and risks that may impact study delivery. Takes a leadership role in identifying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level.
• Provides feedback on performance, capabilities and competencies of study members to line management.
• Ensures appropriate site monitoring activities have been completed per the study monitoring plan and reviews/ approves monitoring visit reports.
• Accountable to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
• As required, advises on contract development with Sites/CRO/Vendors and participates in budget/contract negotiations with study vendors or clinical investigator sites.
• As required, assists with audits/inspections of local clinical operations department and study / sites in the US.
• Takes a leadership role in standardizing processes, identifying and sharing best practices in support of continuous improvement. Represents local/regional clinical operations on global and cross functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally.
• Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards.
• Acts as a role model, coach, mentor for less experienced LDLs on processes, study, technical and behavioral competencies. Provides training for new and less experienced LDLs as required.
• Available and willing to travel as job requires.

Benefits

• health care and other insurance benefits (for employee and family)
• retirement benefits
• paid holidays
• vacation
• paid caregiver/parental and medical leave
• annual bonus
• eligibility to participate in our share based long term incentive program which is dependent on the level of the role

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level