Council of State and Territorial Epidemiologists
Clinical Development Director - Hepatology
Council of State and Territorial Epidemiologists, Somerville, Massachusetts, us, 02145
Job description
Clinical Development Director - Hepatology
leads clinical and scientific strategy for the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The director plans, executes and delivers activities including hepatology translational and clinical development strategies and studies, particularly within steatotic liver disease (SLD). Cross‑functional work develops and executes clinical development plans up to Proof of Mechanism/Proof of Concept.
Key Accountabilities / Responsibilities
Align translational and clinical plans with project strategies, support IEP and CDP quality execution, and develop core regulatory documents.
Generate data and evidence to determine target or medicine efficacy, safety profile, differentiation and route to value for patients.
Define and deliver the clinical pillars of the translational table, including timelines, endpoints and Go/No Go criteria.
Maintain relationships with program counterparts across Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
Embed strategic and organizational initiatives in Clinical Development.
Clinical Development Strategy; Study & Program Design
Provide oversight of R&D evidence generation to assure patient safety and study delivery.
Contribute to study team discussions on indication planning and deliverables such as early Medicine Profile, Target Validation, Translational Plans and Candidate Selection.
Design clinical development plans and study protocols across all phases, reflecting internal and external stakeholder input.
Develop clinical study protocols, amendments, investigator brochures and clinical study reports.
Input to regulatory interactions and documents, including briefing documents and presentations.
Provide medical monitoring and oversight of study participant safety on behalf of the Sponsor during the study.
Clinical Leadership
Accountable for leading the CMT on an EPU program and serve as a clinical point of contact for indications or studies.
Collabrate with cross‑functional teams to ensure cohesive translational and clinical development plans.
Lead end‑to‑end clinical development strategy for an EPU program and contribute to later stages.
Serve as the primary clinical interface with internal RIIRU review boards.
Conduct clinical evaluation of business development opportunities.
Stay abreast of hepatology research and regulatory space to maintain competitive edge.
Gather and support integration of inputs from across disciplines to contribute to clinical components of the Medicine Profile.
Contribute to embedding of strategic initiatives in the EPU.
Demonstrate influence at project, departmental and inter‑departmental levels.
Influencing and Inspiring Others, Managing Conflict
Consistently inspire others by setting a positive example and communicating a compelling vision.
Manage conflicts effectively, negotiate solutions and achieve outcomes through influencing skills.
Enterprise Mindset and Navigating Ambiguity
Demonstrate flexibility and adaptability in changing environments and make informed decisions with incomplete information.
Collaborate across the matrix, integrate cross‑functional knowledge into decision‑making, and balance team objectives with business goals.
Use new learning and digital tools to create innovation in other areas.
Proactively generate ideas for innovative improvement and promote an environment for others to do so.
Why you? We are looking for professionals with the required skills to achieve our goals.
Basic Qualifications
PhD or PharmD (or equivalent) degree required.
Experience in clinical research and development, including postgrad experience.
Knowledge of and experience in execution of translational studies and preclinical biological experiments in relevant model systems.
Robust knowledge of hepatology research priorities, public health needs, competitor landscape, clinical practice trends and treatment guideline evolution.
Experience working with global regulatory agencies and managing global clinical trials in hepatology.
Knowledge of regulatory requirements, Good Clinical Practice (GCP) and ethical guidelines for clinical research.
Preferred Qualifications
Medical Degree Preferred.
Board certified/eligible in gastroenterology with focus in hepatology.
General internal medicine preferred for MDs or alternative experience in the relevant disease area.
Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture.
Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork guide us. GSK is an Equal Opportunity Employer. Flexible working culture is encouraged and can be explored with the hiring team.
For salary ranges and benefits, see the compensation details and flexible working notes provided in the original posting. Contact us at UKRecruitment.Adjustments@gsk.com for adjustments or FAQs linked to the role.
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.
Please note that we do not accept referrals from employment businesses or agencies. All employment business/agency referrals require prior written authorization before referring candidates to GSK.
For US licensed healthcare professionals, GSK may capture and report expenses incurred on your behalf complying with federal and state transparency requirements. For more information, visit https://openpaymentsdata.cms.gov/.
#J-18808-Ljbffr
Clinical Development Director - Hepatology
leads clinical and scientific strategy for the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The director plans, executes and delivers activities including hepatology translational and clinical development strategies and studies, particularly within steatotic liver disease (SLD). Cross‑functional work develops and executes clinical development plans up to Proof of Mechanism/Proof of Concept.
Key Accountabilities / Responsibilities
Align translational and clinical plans with project strategies, support IEP and CDP quality execution, and develop core regulatory documents.
Generate data and evidence to determine target or medicine efficacy, safety profile, differentiation and route to value for patients.
Define and deliver the clinical pillars of the translational table, including timelines, endpoints and Go/No Go criteria.
Maintain relationships with program counterparts across Biology, Translational, Commercial, Research, Regulatory, Clinical Operations, Access, Medical Affairs and Statistics.
Embed strategic and organizational initiatives in Clinical Development.
Clinical Development Strategy; Study & Program Design
Provide oversight of R&D evidence generation to assure patient safety and study delivery.
Contribute to study team discussions on indication planning and deliverables such as early Medicine Profile, Target Validation, Translational Plans and Candidate Selection.
Design clinical development plans and study protocols across all phases, reflecting internal and external stakeholder input.
Develop clinical study protocols, amendments, investigator brochures and clinical study reports.
Input to regulatory interactions and documents, including briefing documents and presentations.
Provide medical monitoring and oversight of study participant safety on behalf of the Sponsor during the study.
Clinical Leadership
Accountable for leading the CMT on an EPU program and serve as a clinical point of contact for indications or studies.
Collabrate with cross‑functional teams to ensure cohesive translational and clinical development plans.
Lead end‑to‑end clinical development strategy for an EPU program and contribute to later stages.
Serve as the primary clinical interface with internal RIIRU review boards.
Conduct clinical evaluation of business development opportunities.
Stay abreast of hepatology research and regulatory space to maintain competitive edge.
Gather and support integration of inputs from across disciplines to contribute to clinical components of the Medicine Profile.
Contribute to embedding of strategic initiatives in the EPU.
Demonstrate influence at project, departmental and inter‑departmental levels.
Influencing and Inspiring Others, Managing Conflict
Consistently inspire others by setting a positive example and communicating a compelling vision.
Manage conflicts effectively, negotiate solutions and achieve outcomes through influencing skills.
Enterprise Mindset and Navigating Ambiguity
Demonstrate flexibility and adaptability in changing environments and make informed decisions with incomplete information.
Collaborate across the matrix, integrate cross‑functional knowledge into decision‑making, and balance team objectives with business goals.
Use new learning and digital tools to create innovation in other areas.
Proactively generate ideas for innovative improvement and promote an environment for others to do so.
Why you? We are looking for professionals with the required skills to achieve our goals.
Basic Qualifications
PhD or PharmD (or equivalent) degree required.
Experience in clinical research and development, including postgrad experience.
Knowledge of and experience in execution of translational studies and preclinical biological experiments in relevant model systems.
Robust knowledge of hepatology research priorities, public health needs, competitor landscape, clinical practice trends and treatment guideline evolution.
Experience working with global regulatory agencies and managing global clinical trials in hepatology.
Knowledge of regulatory requirements, Good Clinical Practice (GCP) and ethical guidelines for clinical research.
Preferred Qualifications
Medical Degree Preferred.
Board certified/eligible in gastroenterology with focus in hepatology.
General internal medicine preferred for MDs or alternative experience in the relevant disease area.
Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture.
Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork guide us. GSK is an Equal Opportunity Employer. Flexible working culture is encouraged and can be explored with the hiring team.
For salary ranges and benefits, see the compensation details and flexible working notes provided in the original posting. Contact us at UKRecruitment.Adjustments@gsk.com for adjustments or FAQs linked to the role.
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.
Please note that we do not accept referrals from employment businesses or agencies. All employment business/agency referrals require prior written authorization before referring candidates to GSK.
For US licensed healthcare professionals, GSK may capture and report expenses incurred on your behalf complying with federal and state transparency requirements. For more information, visit https://openpaymentsdata.cms.gov/.
#J-18808-Ljbffr