GSK
Associate Director, Clinical Scientist Oncology
GSK, Waltham, Massachusetts, United States, 02254
Associate Director, Clinical Scientist Oncology
Join to apply for the Associate Director, Clinical Scientist Oncology role at GSK.
Overview The Associate Director, Clinical Scientist Oncology is accountable for providing clinical input during protocol development, oversight of study conduct, and interpretation of study results to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient‑reported outcomes, and to ensure applicability of data to the target patient population. The role leads a clinical matrix team, ensures patient safety, fulfills regulatory and reporting requirements, supports medical governance, and designs and executes clinical trials in collaboration with the Medical Director.
Job Responsibilities
Deliver quality study strategy and design, ensuring consistent data analysis and interpretation throughout the study.
Lead or contribute to end‑to‑end clinical development activities, integrating global considerations into strategic and operational decisions.
Understand the asset’s biological mechanism, clinical strategy, and scientific interpretation of disease and target literature.
Integrate internal and external data sources, including academic and competitor information.
Support creation of competitor landscape, medical need, and regulatory strategy.
Interact appropriately with Key External Experts, Key Opinion Leaders, and collaborators.
Implement new business processes, proactively identify issues, and propose strategies to manage risks on clinical studies.
Ensure high‑quality protocol documents aligned with the Clinical Development Plan.
Drive or contribute to documents for regulatory submissions.
Develop studies in accordance with GSK policies and procedures.
Accountabilities
Accountable for Phase 1‑4 study design, including clinical pharmacology designs supporting the CDP.
Author the Clinical Study Proposal, prepare and present at Protocol Review Forums, and incorporate governance feedback.
Ensure protocol reflects input from internal and external experts.
Liaise with all functions to evaluate key aspects of the asset product profile.
Contribute to specialized study documents (ICF, PDMP, SRM).
Support regulatory reporting (DSUR, INDSR, etc.) and respond to IRB/ERC and IDMC inquiries.
Participate in eCRF development and user acceptance testing.
Review and advise on reporting and analysis plans.
Participate in data reviews, including interim analyses.
Establish Go/No‑Go criteria and present scientific rationale at investigator meetings.
Ensure prompt communication with sites and completion of medical governance.
Interpret study data and contribute to clinical study reports and regulatory submissions.
Prepare and present data at conferences and for journal publications.
Deliver end‑of‑study reports and publications.
Basic Qualifications
Bachelor’s degree in Life Sciences or equivalent.
2+ years of experience in the pharma industry or relevant clinical trial experience.
1+ year of experience running clinical trials in early or late phases.
Experience working in a matrix management and large cross‑functional team environment.
Experience generating clinical protocols and ICFs.
Experience working with data management and data cleaning of clinical data.
Preferred Qualifications
Advanced degree (MS, PhD, PharmD, RN, Nurse Practitioner) or equivalent experience.
Oncology or immuno‑oncology experience preferred.
Ability to establish and build internal and external relationships at all levels.
Strong communication skills appropriate to the target audience.
Good knowledge of disease‑specific research priorities and competitor landscape.
Broad understanding of the pharmaceutical industry, clinical development process, and regulatory requirements.
Leadership and influencing skills, with experience leading cross‑functional clinical development projects from early stages to regulatory submission.
Excellent interpersonal skills, with a thorough knowledge of worldwide regulatory and safety requirements.
Equal Opportunity Employer 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, military service or any basis prohibited under federal, state or local law.
#J-18808-Ljbffr
Overview The Associate Director, Clinical Scientist Oncology is accountable for providing clinical input during protocol development, oversight of study conduct, and interpretation of study results to define safety, efficacy, pharmacokinetic/pharmacodynamic, and patient‑reported outcomes, and to ensure applicability of data to the target patient population. The role leads a clinical matrix team, ensures patient safety, fulfills regulatory and reporting requirements, supports medical governance, and designs and executes clinical trials in collaboration with the Medical Director.
Job Responsibilities
Deliver quality study strategy and design, ensuring consistent data analysis and interpretation throughout the study.
Lead or contribute to end‑to‑end clinical development activities, integrating global considerations into strategic and operational decisions.
Understand the asset’s biological mechanism, clinical strategy, and scientific interpretation of disease and target literature.
Integrate internal and external data sources, including academic and competitor information.
Support creation of competitor landscape, medical need, and regulatory strategy.
Interact appropriately with Key External Experts, Key Opinion Leaders, and collaborators.
Implement new business processes, proactively identify issues, and propose strategies to manage risks on clinical studies.
Ensure high‑quality protocol documents aligned with the Clinical Development Plan.
Drive or contribute to documents for regulatory submissions.
Develop studies in accordance with GSK policies and procedures.
Accountabilities
Accountable for Phase 1‑4 study design, including clinical pharmacology designs supporting the CDP.
Author the Clinical Study Proposal, prepare and present at Protocol Review Forums, and incorporate governance feedback.
Ensure protocol reflects input from internal and external experts.
Liaise with all functions to evaluate key aspects of the asset product profile.
Contribute to specialized study documents (ICF, PDMP, SRM).
Support regulatory reporting (DSUR, INDSR, etc.) and respond to IRB/ERC and IDMC inquiries.
Participate in eCRF development and user acceptance testing.
Review and advise on reporting and analysis plans.
Participate in data reviews, including interim analyses.
Establish Go/No‑Go criteria and present scientific rationale at investigator meetings.
Ensure prompt communication with sites and completion of medical governance.
Interpret study data and contribute to clinical study reports and regulatory submissions.
Prepare and present data at conferences and for journal publications.
Deliver end‑of‑study reports and publications.
Basic Qualifications
Bachelor’s degree in Life Sciences or equivalent.
2+ years of experience in the pharma industry or relevant clinical trial experience.
1+ year of experience running clinical trials in early or late phases.
Experience working in a matrix management and large cross‑functional team environment.
Experience generating clinical protocols and ICFs.
Experience working with data management and data cleaning of clinical data.
Preferred Qualifications
Advanced degree (MS, PhD, PharmD, RN, Nurse Practitioner) or equivalent experience.
Oncology or immuno‑oncology experience preferred.
Ability to establish and build internal and external relationships at all levels.
Strong communication skills appropriate to the target audience.
Good knowledge of disease‑specific research priorities and competitor landscape.
Broad understanding of the pharmaceutical industry, clinical development process, and regulatory requirements.
Leadership and influencing skills, with experience leading cross‑functional clinical development projects from early stages to regulatory submission.
Excellent interpersonal skills, with a thorough knowledge of worldwide regulatory and safety requirements.
Equal Opportunity Employer 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, military service or any basis prohibited under federal, state or local law.
#J-18808-Ljbffr