Connecting Odds
GSK

Director, Clinical Operations Asset Lead (COAL), Late Phase Lung Oncology

GSK
USA - Pennsylvania - Upper Providence; GSK HQ Posted Discovered via the company's careers siteMatch locked
Full time3+ years exp

About the role

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.

The Clinical Operations Asset Lead (COAL), Late Phase Lung Oncology

is accountable for the operational strategy and delivery of complex global clinical programs across the asset lifecycle. As a key member of the Medicine Development Team, the COAL translates scientific strategy into executable operational plans, partnering across Clinical Development, Biostatistics and functional experts to enable informed asset decisions. This role provides strategic leadership to Study Delivery Teams and oversees delivery across multiple studies, indications and combinations, while retaining overall accountability for successful asset delivery.

Key Responsibilities

  • Own the clinical operational strategy and end-to-end delivery of the asset

, from candidate commitment through development, late-phase delivery and lifecycle management. •

Shape the Clinical Development Plan and Integrated Evidence Plan

, ensuring studies are operationally feasible, scientifically aligned and positioned for high-quality, timely delivery. •

Lead asset-level operational planning and scenario modelling

, balancing timelines, cost, resources, quality and risk to inform governance decisions and optimize delivery. •

Define and oversee the asset resourcing strategy

, including insourcing/outsourcing decisions, vendor selection and oversight of external delivery partners. •

Provide strategic leadership across Study Delivery Teams

, coordinating cross-functional expertise and acting as the senior escalation point for significant operational, quality and delivery issues. •

Drive asset-level risk management, quality and inspection readiness

, embedding Quality by Design principles and ensuring effective mitigation of operational and GCP-related risks. •

Lead operational strategies across countries, patient engagement, diversity and study execution

, bringing innovation, technology and external insights into asset delivery. •

Ensure robust financial, data and stakeholder governance

, including accurate budget forecasting, operational data, regulatory submission contributions and effective communication across clinical operations and asset stakeholders.

Basic Qualifications

We are seeking professionals with the following required skills and qualifications to help us achieve our goals

  • Bachelor's degree in life sciences, healthcare, business or a related field, or equivalent experience.
  • Minimum of 10 years of pharmaceutical R&D or related industry experience.
  • At least 3 years of experience as COAL (or similar role) in lung cancer indications
  • 5 years + experience successfully managed global, complex programs with multiple studies
  • Demonstrated experience with preparing for BLA filing (from early prep to actual filing) and BLA inspection readiness
  • Deep therapeutic area expertise and solid knowledge of the lung treatment landscape and competitive environment

Preferred Qualification

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

  • Advanced degree (Master's, PhD, PharmD, MD) in a relevant discipline.
  • Day-to-day fluency in using AI to accelerate trial timelines, improve data quality, evidence assurance, and reduce time spent on manual tasks.
  • Experience leading global portfolios or cross-region evidence programs.
  • Strong data fluency, including experience using dashboards and performance metrics to drive decisions.
  • Experience with vendor oversight and partnerships with CROs, academic networks or external investigators.
  • Demonstrated success delivering process improvements or digital-enabled transformation in evidence generation.

#LI-GSK*

Skills

Analytical Thinking, Clinical Data Interpretation, Clinical Data Review, Clinical Development, Clinical Trial Designs, Clinical Trials Monitoring, Digital Fluency, Drug Regulatory Affairs, Executive Presence, Hematology and Oncology, Learning Agility, Matrix Leadership, Real World Evidence (RWE), Scientific Presentations

  • 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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Uniting 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com . 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Not included in the source posting: benefits.

Skills

artificial-intelligencegcp

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