Study Director Jobs in Indiana (NOW HIRING)

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 toCambridge. The location of this role will therefore subsequently change to Cambridge 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.
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Our approach to R&D

Overview

Cancer is unrelenting, but so are we. At GSK, we are committed to transforming outcomes for people with cancer through innovative science, bold ambition, and strong partnerships across the healthcare ecosystem. We focus our science where it can matter most-advancing care in cancers with high unmet need, grounded in a deep understanding of disease biology and deliberate scientific choices that connect discovery to meaningful impact in the real world.

The Director, Clinical Science - Oncology Clinical Development 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 Scientist 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

Data Generation, Analysis, and Interpretation

• 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

Why You?
Working model:

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.

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 or related scientific discipline required

5+ years of 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
If you have the following characteristics, it would be a plus:

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)

Oncology or immuno-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.

What we value
We act with transparency, respect and integrity. We welcome different perspectives and champion inclusion. Bring curiosity, humility and a clear focus on patients.
Apply now
If this role matches your experience and career goals, please apply. Tell us how your experience will drive clinical progress and how you want to grow with us. We look forward to hearing from you.

Ready to apply?
If you want to help shape clinical development and make a real difference for patients, we would like to hear from you. Please submit your resume and a short cover letter describing your relevant experience and why this role matters to you. We welcome applicants from all backgrounds and are committed to inclusion.

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.Polish Salary Range / Polski przedzia wynagrodzenia: PLN 472,500 to PLN 787,500The 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 location or country, 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.

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

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.

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, s...