Director, Clinical Science – Oncology Clinical Development GYN

1925 GlaxoSmithKline LLC; Waltham (MA); Híbrido; USD 190.000 - 316.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health care benefits

Retirement benefits

Paid holidays

Descripción de la vacante

GlaxoSmithKline plc in the United States is seeking a Director, Clinical Science – Oncology Clinical Development GYN to provide scientific leadership across study design, data review and interpretation within an assigned programme. The role collaborates with cross‑functional teams to ensure quality, regulatory alignment and strategic execution.

This hybrid position is on‑site at US locations (Cambridge, MA or Waltham, MA) at least two days per week, with remote days available.

Formación

• Bachelor’s degree in life sciences or related field.
• Experience in pharmaceutical/biotech clinical development.
• Experience with protocol authoring, data review and regulatory submissions.

Responsabilidades

• Provide scientific leadership for protocol development and study design.
• Support data review, interpretation, and regulatory submissions.
• Ensure quality and consistency of study documents (IBs, CSRs).
• Collaborate with cross-functional teams and external experts.

Conocimientos

Analytical Thinking

Clinical Data Interpretation

Clinical Data Review

Clinical Development

Hematology and Oncology

Educación

Bachelor’s degree in life sciences

Advanced degree (MS/PhD/PharmD) preferred

Descripción del empleo

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029. 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 Cancer is unrelenting, but so are we.

The Director, Clinical Science – Oncology Clinical Development GYN provides scientific leadership across defined components of study design, conduct, data review, and interpretation within an assigned clinical programme. Reporting to the Clinical Development Lead (CDL), this role operates within the asset‑level clinical strategy and contributes scientific depth and rigour to the execution of the Clinical Development Plan (CDP). The Director, Clinical Science partners closely with the Senior Scientist and cross‑functional teams to support delivery of clinical studies, ensuring scientific quality, data integrity, and robust interpretation of clinical data. This role contributes to both study‑level activities and broader programme insights, without holding accountability for asset‑level strategy or overall study delivery. This is a scientific individual contributor role requiring deep oncology clinical development expertise, strong analytical and collaboration skills, and the ability to operate effectively within a complex, matrixed environment.

In This Role You Will:

• Provide scientific leadership across defined components of study‑level activities, including protocol development, study design, data review, and interpretation, within the strategic direction set by the CDL
• Serve as a core member of the Clinical Matrix Team (CMT), ensuring scientific alignment across study objectives, timelines, and deliverables
• Provide scientific insight to the CDL and Senior Scientist to inform asset‑level strategy, benefit–risk assessment, and programme‑level decision‑making
• Ensure the scientific quality and consistency of key clinical and regulatory documents, including protocols, Investigator’s Brochures, Clinical Study Reports, and submission materials
• Apply scientific and clinical expertise to analyse and interpret data, ensuring rigour, integrity, and relevance to the target patient population
• Engage with internal and external stakeholders, including investigators and Key External Experts, to support study execution and scientific exchange
• Contribute to a culture of scientific excellence, innovation, and continuous improvement within Oncology Clinical Development

Detailed Responsibilities:

Study Design and Execution

• Provide scientific input into protocol development and study design, ensuring robustness, feasibility, and alignment with CDP‑defined objectives and regulatory requirements
• Author or co‑author key study documents (e.g., Clinical Study Proposals), contributing to preparation and presentation at governance forums such as Protocol Review Boards
• Support study conduct by addressing scientific questions, ensuring data integrity, and maintaining alignment with protocol and regulatory standards
• Provide scientific input into study‑level decisions related to protocol implementation and study conduct, within the strategic framework defined by the CDL
• Present and support the scientific rationale and study design at Investigator Meetings and respond to scientific inquiries from study sites
• Support implementation of study‑level Go/No‑Go criteria aligned to the asset‑level decision framework defined by the CDL
• Analyse and interpret clinical data to generate insights on safety, efficacy, and patient populations
• Integrate data from internal and external sources (e.g., literature, competitor data, emerging science) to inform study and programme understanding
• Provide scientific input into data review and interpretation activities, in collaboration with Medical Directors and pharmacovigilance
• Translate study findings into clear scientific insights to inform programme progression and support CDL‑led decision‑making

Clinical and Regulatory Deliverables

• Contribute to development of clinical and regulatory documents, including protocols, Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), and submission materials
• Ensure scientific accuracy, consistency, and quality across study documentation
• Support preparation of regulatory submissions and responses to Health Authority queries
• Contribute to regulatory reporting requirements (e.g., DSURs, INDSRs) and ensure alignment with regulatory standards

Cross‑Functional Collaboration & Scientific Contribution

• Serve as a core member of the CMT, partnering with Clinical Operations, Statistics, Safety, Regulatory, and Medical Affairs to support integrated study delivery
• Provide scientific expertise to cross‑functional discussions, including integrated evidence planning and disease‑area forums, as appropriate
• Participate in internal and external scientific interactions with investigators, Key External Experts, advisory boards, and collaborators
• Contribute to scientific communications, including publications, congress presentations, and study‑related materials

Ways of Working & Continuous Improvement

• Identify scientific and operational risks at the study level and provide input into mitigation strategies
• Support and drive implementation of consistent ways of working and process improvements across the programme
• Participate in Oncology Clinical Development initiatives and workstreams to strengthen standards, processes, and capabilities
• Engage in ongoing development to deepen scientific expertise, expand disease‑area knowledge, and build broader clinical development capabilities

Basic Qualifications

• Bachelor’s degree in life sciences or related scientific discipline required
• Experience in pharmaceutical/biotechnology industry or related clinical development experience, with a focus on oncology
• Experience in clinical development from early stage through to regulatory submission, including study design, protocol authoring, and data review/interpretation
• Experience working within GCP, ICH, and global regulatory guidelines
• Experience authoring or contributing to clinical study proposals, protocols, Investigator’s Brochures, informed consent forms, clinical study reports, and regulatory submissions
• Experience working within cross‑functional matrix teams and contributing to clinical decision‑making
• Proven track record of working with investigators, site staff, external experts, CROs, and vendors

Preferred Qualifications

• Advanced degree (e.g. MS, PhD, PharmD) strongly preferred in life sciences or a related discipline
• Clinical development experience across multiple phases of development (Phase I–IV)
• GYN Oncology clinical development experience
• Experience presenting or preparing materials for Protocol Review Boards, governance meetings, or scientific forums
• Knowledge of regulatory requirements to support registration, including experience contributing to IND, EoP2, scientific advice, pre‑NDA/BLA, NDA/MAA, or AdCom submissions

Working Arrangement

This role is hybrid. You will be on‑site at one of the posted locations at least two days per week. Remote work is available on other days.

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.

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.

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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 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.