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Director, Clinical Operations Asset Lead

$189.75k - $316.25k

Glaxosmithkline

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 program‑level operational strategy that enables execution of the scientific vision. Working in close partnership with clinical, biostatistics, and functional experts, the COAL drives informed decision‑making, provides strategic leadership to Study Delivery Teams, and ensures high‑quality, on‑time 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, cost‑effective, and deliver high‑quality data Provide protocol‑level operational input and support amendments through governance review Resourcing & Vendor Strategy Lead and own the asset‑level resourcing strategy (in‑house 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 cross‑functional coordination to ensure inspection readiness and high‑quality study delivery Ensure transparent communication of risks, issues, and successes across GCO Operational Delivery & Governance Own asset‑level delivery plans, scenario modeling, and budget forecasts Drive innovative, patient‑centric and efficient approaches to study execution Represent Clinical Operations at governance boards and support clinical filing activities Risk, Data & Stakeholder Management Own the asset‑level 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. Basic Qualifications Bachelor’s degree in general science or life/health related Science Degree Extensive portfolio‑level strategic experience leading and delivering complex clinical research programs or equivalent initiatives with significant business impact. Expert‑level experience across end‑to‑end clinical development and the regulatory landscape, enabling proactive, innovative strategic guidance and independent leadership of complex cross‑functional 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 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. 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 Polish Salary Range / Polski przedział wynagrodzenia: PLN 429,000 to PLN 715,000 Italian Salary Range / Fascia retributiva in Italia: EUR 81,750 to EUR 136,250 Belgium Salary Range / Fourchette salariale - Belgique: EUR 119,250 to EUR 198,750 The 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. 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 przedział wynagrodzenia: PLN 429,000 to PLN 715,000 Italian Salary Range / Fascia retributiva in Italia: EUR 81,750 to EUR 136,250 Belgium Salary Range / Fourchette salariale - Belgique: EUR 119,250 to EUR 198,750 The 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 in the job posting for a specific country or location, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria. Why GSK? Unifying science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at View email address on click.appcast.io where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Where you will find answers to multiple questions we receive. We are 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 impact the health of 2.5 billion people around the world in the next 10 years. 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site. #J-18808-Ljbffr GSK

Vacancy posted 2 days ago
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