Director, Clinical Operations Asset Lead Oncology

GlaxoSmithKline; Upper Providence (Delaware County); Hybrid; USD 150,000 - 210,000; Full time

Job summary

GSK seeks an experienced Clinical Operations Asset Lead to represent Development Operations at asset level and at EDT/MDT, shaping the program's operational strategy and delivery.

You will coordinate clinical, biostatistics, safety, and vendors across early and late-phase oncology programs, manage resourcing and feasibility, ensure inspection readiness, and contribute to regulatory deliverables and budgeting.

Qualifications

• Bachelor's degree in life sciences, health sciences or equivalent qualification.
• Experience in oncology clinical operations (solid tumours and haemato-oncology).
• Experience in oncology early-phase development (FiH/Ph1).
• Experience in vendor management and CRO oversight.
• Experience applying GCP and clinical development processes.
• Experience delivering global clinical program oversight across regions.
• Ability to manage multiple stakeholders and communicate in English (written and spoken).

Responsibilities

• Lead and support the operational strategy and delivery for oncology programs per the clinical development plan.
• Represent Development Operations at EDT/MDT.
• Coordinate cross-functional inputs from clinical, biostatistics, safety, clinical supplies and vendors to meet timelines and quality.
• Contribute to protocol development, feasibility assessments and resourcing decisions (insourcing vs outsourcing).
• Maintain inspection readiness and quality oversight with risk management and escalation for serious breaches.
• Provide operational input for regulatory deliverables and governance, including budgeting for clinical activities.
• Act as a point of contact for stakeholders and vendors to ensure consistent execution across studies and sub-projects.

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

Scientific Presentations

Education

Bachelor's degree in life sciences, health sciences or equivalent qualification

Job description

Role Summary

The Clinical Operations Asset Lead represents all Development Operations functions at the asset level and at Early Development Team (EDT) or Medicine Development Team (MDT) and other asset team interactions and is accountable for developing the program level operational strategy and delivery plan to execute the scientific strategy for an asset and, working in partnership with clinical / biostats / clinical supplies and the functional subject matter experts to ensure informed asset decision-making from the operational, scientific and data perspectives.

Key Responsibilities

• Lead and support the operational strategy and delivery for assigned early phase oncology programs and/or late phase development programs, ensuring alignment with the clinical development plan.


• Represent Development Operations at EDT/MDT.


• Coordinate cross-functional inputs from clinical, biostatistics, safety, clinical supplies and vendors to meet timelines and quality expectations.


• Contribute to protocol development, operational feasibility assessments and resourcing decisions, including insourcing versus outsourcing recommendations.


• Maintain inspection readiness and quality oversight, supporting risk management, mitigation plans and serious breach escalation when needed.


• Provide operational input for regulatory deliverables and governance forums, including scenario modelling and budget forecasting for clinical activities.


• Act as a point of contact for stakeholders and vendors to ensure consistent execution across studies and sub-projects.

Basic Qualification

• Bachelor's degree in life sciences, health sciences or equivalent qualification.


• Experience in oncology clinical operations (both solid tumours and haemato-oncology).


• Experience in oncology early-phase development (FiH/Ph1).


• Experience in vendor management and oversight of Contract Research Organization (CRO) relationships.


• Experience working in roles requiring application of Good Clinical Practice (GCP) and clinical development processes.


• Experience delivering global clinical program oversight across multiple regions.


• Ability to manage multiple stakeholders and communicate effectively in written and verbal English in a professional setting.

Preferred Qualification

• Experience working on complex, multi-indication programs.


• Experience in phase 1 healthy volunteer studies.


• Formal project management training or certification.


• Experience contributing to regulatory submission content or supporting regulatory interactions.


• Experience with budgeting and forecasting for clinical studies and programs.


• Familiarity with clinical supplies, bio-sample management or diagnostic implementation.


• Experience working in matrix teams and mentoring junior colleagues.

Work Arrangement

This role offers a hybrid working model, with a mix of on-site and remote work.

Closing date for applications is Monday 28th September

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

Why GSK?

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.

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 [e-mail] 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. Click the link where you will find answers to multiple questions we receive.

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/