Director, Clinical Operations Asset Lead

GlaxoSmithKline; Upper Providence (Delaware County); On-site; USD 190,000 - 316,000; Full time

Benefits offered by this job

Health care benefits

Retirement benefits

Paid time off

Paid family leave

Job summary

GlaxoSmithKline is seeking a Clinical Operations Asset Lead to serve as the single point of accountability for operational delivery across the asset lifecycle. You will partner with clinical, biostatistics, and functional experts to drive strategy and ensure timely, high-quality study delivery while managing budgets and risks.

The role spans early and late phase responsibilities, leading crossfunctional teams, stakeholder engagement, and governance representation within Global Clinical

Qualifications

• Bachelor's degree in general science or life/health related Science.
• Extensive portfolio-level strategic experience leading complex clinical programs.
• Expert-level experience across end-to-end clinical development and regulatory landscape.

Responsibilities

• Contribute to the Clinical Development Plan (CDP) and Integrated Evidence Plan (IEP) across Research, Development, and LCM.
• Ensure study designs are operationally feasible, regionally compliant, costeffective, and deliver highquality data.
• Provide protocollevel operational input and support amendments through governance review.
• Lead the assetlevel resourcing strategy (inhouse vs outsourced) and vendor oversight.
• Serve as escalation point for operational, quality, and GCP issues; ensure inspection readiness.
• Own assetlevel delivery plans, scenario modeling, and budget forecasts; drive efficient study execution.
• Represent Clinical Operations at governance boards and support clinical filing activities.

Skills

Analytical Thinking

Leadership

Stakeholder Management

Strategic Thinking

Decision Making

Communication

Change Management

Risk Management

Education

Bachelor's degree in general science or life/health related Science Degree

Job description

Business Introduction

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.

Position Summary

The Clinical Operations Asset Lead is the single point of accountability for clinical operations delivery across the full asset lifecycle. Representing Global Clinical Operations at the asset level, the COAL sets and delivers the programlevel operational strategy that enables execution of the scientific vision.

Working in close partnership with clinical, biostatistics, and functional experts, the COAL drives informed decisionmaking, provides strategic leadership to Study Delivery Teams, and ensures highquality, ontime delivery-while retaining full accountability for overall asset outcomes.

This COAL may take on responsibilities across both early and late phase, depending upon demand in our RIIRU portfolio.

Key Responsibilities:

Asset & Development Strategy

• Contribute to the Clinical Development Plan (CDP) and Integrated Evidence Plan (IEP) across Research, Development, and LCM
• Ensure study designs are operationally feasible, regionally compliant, costeffective, and deliver highquality data
• Provide protocollevel operational input and support amendments through governance review

Resourcing & Vendor Strategy

• Lead and own the assetlevel resourcing strategy (inhouse vs outsourced)
• Approve vendor selection, contracting, and oversight in line with GSK standards

Delivery Quality & Inspection Readiness

• Serve as escalation point for critical operational, quality, and GCP issues
• Lead crossfunctional coordination to ensure inspection readiness and highquality study delivery
• Ensure transparent communication of risks, issues, and successes across GCO

Operational Delivery & Governance

• Own assetlevel delivery plans, scenario modeling, and budget forecasts
• Drive innovative, patientcentric and efficient approaches to study execution
• Represent Clinical Operations at governance boards and support clinical filing activities

Risk, Data & Stakeholder Management

• Own the assetlevel risk register and mitigation strategy using Quality by Design
• Ensure accurate, current operational data in GSK systems until transition to study teams
• Lead internal and external stakeholder engagement across the asset

Capabilities:

• Demonstrates conceptual, analytical and strategic thinking to innovative approaches to clinical delivery, leverage external technology and networks and build internal capability
• Ability to translate strategic concepts, scientific requirements, stakeholder feedback and expectations into cohesive actions for the Asset team
• Innovative and change adept whilst identifying and embracing risks as opportunities
• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment, demonstrating conflict management and negotiation skills
• Partnering skills with key role such as clinical science, biostatistics and other subject matter experts (SME) at asset level to articulate and champion key decisions and strategy
• Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives
• Strong influencing and stakeholder management skills at all levels of the organization.
• Strong communication skills appropriate to the target audience, promoting effective decision-making
• Leadership style sensitive to different cultures and experience levels in a matrix environment to ensure appropriate asset operational delivery and optimally motivate individuals to reach their potential

Why you?

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

• Bachelor's degree in general science or life/health related Science Degree
• Extensive portfoliolevel strategic experience leading and delivering complex clinical research programs or equivalent initiatives with significant business impact.
• Expertlevel experience across endtoend clinical development and the regulatory landscape, enabling proactive, innovative strategic guidance and independent leadership of complex crossfunctional teams.
• Proven experience navigating and strategizing across multiple regulatory pathways potentially pursued simultaneously for different indications.
• Ability to develop and execute integrated strategic plans across multiple streams and indications for one large asset or multiple interdependent assets
• Excellent leadership skills building and managing matrixed teams, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives within highly complex and high-pressure environments, while maintaining visibility at a senior level.
• Excellent influencing and stakeholder management skills at all levels of the organization (including SVP and C-level).
• Competent in working with complexity and uncertainty within the external regulatory environment (e.g. FDA, EMEA)

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Masters's Degree in General Science or life/health related Science Degree or MBA
• Preferred experience leading or contributing to operational integration aspects of BD deals
• Demonstrated cross-functional collaborator with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.

#LI-GSK*

Skills

Analytical Thinking, Business Acumen, Change Management, Clinical Research, Clinical Trial Designs, Communication, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Risk Management, Strategic Thinking* If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $189,750 to $316,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.Polish Salary Range / Polski przedzia wynagrodzenia: PLN 429,000 to PLN 715,000Italian Salary Range / Fascia retributiva in Italia: EUR 81,750 to EUR 136,250Belgium Salary Range / Fourchette salariale - Belgique: EUR 119,250 to EUR 198,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed