GlaxoSmithKline
Clinical Development Director - Renal
GlaxoSmithKline, Collegeville, Pennsylvania, United States, 19426
Overview
The Clinical Development Director - Renal provides clinical and scientific insights and leadership to renal translational and clinical development activities within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The role works with project teams to plan, execute, and deliver translational and clinical development strategies and clinical studies, including plans up to Proof of Mechanism/Proof of Concept studies. This role offers opportunities to lead key activities and advance your career. Key responsibilities and activities include leading cross-functional clinical development plans and supporting program strategies, with collaboration across Biology, Translational, Commercial, Regulatory, Clinical Operations, Access, Medical Affairs, and Statistics. Key Accountabilities / Responsibilities
Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of the Integrated Evidence Plan (IEP) and Clinical Development Plan (CDP). Develop sections of core regulatory documents. Generate data and evidence to determine target/medicine potential efficacy and safety profile, key differentiators, and a route to delivering value to patients in the shortest timeframe. Define and deliver the clinical pillars of the translational table. Deliver clinical development timelines and endpoints, including pharmacology, mechanism, and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP. Seek and maintain relationships with program counterparts in Biology, Translational Science, Commercial, Regulatory, Clinical Operations, Access, Medical Affairs, and Statistics. Contribute to the implementation and embedding of strategic and organizational initiatives in Clinical Development. Provide effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery. Contribute to study team discussions on indication planning, incorporating input from scientific, clinical, commercial, regulatory, and statistical functions to deliver essential outputs (e.g., early Medicine Profile, Target Validation, Translational Plans, Candidate Selection). Design clinical development plans and study protocols across all development phases, reflecting input from patients, evidence generation, regulators, payors, and pharmacovigilance. Develop clinical study protocols, amendments, investigator brochures, and clinical study reports. Contribute to regulatory interactions and documents, including briefing documents, presentations, and responses for assigned studies and programs. Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor, in collaboration with Pharmacovigilance, and ensure scientific integrity and safety across the study subjects. Accountable for leading the Clinical Management Team (CMT) on an EPU program. Serve as the clinical point of contact for an indication or clinical study and represent the clinical matrix team at EDT or CMT. Collaborate with cross-functional teams to ensure cohesive translational and clinical development plans; act as Clinical Lead at the study level. Lead the end-to-end clinical development strategy for an EPU program and may contribute to later stages. Serve as primary clinical interface with internal RIIRU/GSK review boards and with external stakeholders (regulatory agencies, key opinion leaders, clinical investigators). Contribute to the clinical components of the Medicine Profile and gather inputs across disciplines to solve study and development plan challenges. Stay abreast of renal research advancements, trial methodologies, and regulatory developments to maintain GSK's competitive edge and identify transformational opportunities for patients. Support the integration of cross-disciplinary inputs and contribute to strategic initiatives within the EPU. Demonstrate the ability to influence others at project, departmental, and cross-functional levels as appropriate. Influencing and inspiring others: set a positive example, communicate a compelling vision, and create an environment where team members feel valued and motivated. Conflict management: demonstrate experience in managing conflicts effectively and negotiating mutually acceptable solutions. Influence skills: tailor communications to different audiences and use persuasive arguments to gain support. Enterprise mindset and navigating ambiguity: adapt to changing environments, analyze incomplete information, identify risks, and make informed decisions; collaborate across the matrix and balance team objectives with wider business goals; embrace challenges as opportunities for innovation; use digital tools to drive improvement. Qualifications
Basic Qualifications:
We are looking for professionals with these required skills: PhD or PharmD (or equivalent) with 13 years of postgraduate experience. Minimum of 3 years of experience in clinical research and development (may include postgraduate experience). Robust knowledge of renal-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines. Experience working with global regulatory agencies and managing global clinical trials in nephrology. Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research. Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards. Preferred Qualifications:
If you have the following characteristics, it would be a plus: Medical Degree and Board certification/eligibility in Nephrology Experience contributing to NDA, BLA or MAA submissions Why GSK?
Our values and expectations are at the heart of everything we do and are part of our culture. These include Patient focus, Transparency, Respect, Integrity, Courage, Accountability, Development, and Teamwork. 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 millions by the end of the decade, focusing on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to an agile working culture and a diverse, inclusive workplace. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants receive equal consideration for employment regardless of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military status, or any basis prohibited by law. If you require adjustments to our process to demonstrate your strengths, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available 8:30am12:00 noon Monday to Friday; hours may vary on bank holidays. Please note that if your enquiry does not relate to adjustments, we may not be able to assist through these channels. A UK Recruitment FAQ guide is available in the Careers section for common questions. Important notice to Employment businesses/Agencies:
GSK does not accept referrals from employment businesses or agencies for vacancies posted on this site. All employment businesses/agencies must obtain prior written authorization from GSK before referring candidates. #J-18808-Ljbffr
The Clinical Development Director - Renal provides clinical and scientific insights and leadership to renal translational and clinical development activities within the Early Pipeline Unit (EPU) of the Respiratory, Immunology and Inflammation Research Unit (RIIRU). The role works with project teams to plan, execute, and deliver translational and clinical development strategies and clinical studies, including plans up to Proof of Mechanism/Proof of Concept studies. This role offers opportunities to lead key activities and advance your career. Key responsibilities and activities include leading cross-functional clinical development plans and supporting program strategies, with collaboration across Biology, Translational, Commercial, Regulatory, Clinical Operations, Access, Medical Affairs, and Statistics. Key Accountabilities / Responsibilities
Support alignment of translational and clinical plans and study designs with project strategies to ensure quality execution of the Integrated Evidence Plan (IEP) and Clinical Development Plan (CDP). Develop sections of core regulatory documents. Generate data and evidence to determine target/medicine potential efficacy and safety profile, key differentiators, and a route to delivering value to patients in the shortest timeframe. Define and deliver the clinical pillars of the translational table. Deliver clinical development timelines and endpoints, including pharmacology, mechanism, and clinical efficacy endpoints, enabling key decision points and Go/No Go criteria for the CDP. Seek and maintain relationships with program counterparts in Biology, Translational Science, Commercial, Regulatory, Clinical Operations, Access, Medical Affairs, and Statistics. Contribute to the implementation and embedding of strategic and organizational initiatives in Clinical Development. Provide effective support and oversight of R&D evidence generation activities to assure patient safety and study delivery. Contribute to study team discussions on indication planning, incorporating input from scientific, clinical, commercial, regulatory, and statistical functions to deliver essential outputs (e.g., early Medicine Profile, Target Validation, Translational Plans, Candidate Selection). Design clinical development plans and study protocols across all development phases, reflecting input from patients, evidence generation, regulators, payors, and pharmacovigilance. Develop clinical study protocols, amendments, investigator brochures, and clinical study reports. Contribute to regulatory interactions and documents, including briefing documents, presentations, and responses for assigned studies and programs. Provide medical monitoring and oversight of the safety of study participants on behalf of the Sponsor, in collaboration with Pharmacovigilance, and ensure scientific integrity and safety across the study subjects. Accountable for leading the Clinical Management Team (CMT) on an EPU program. Serve as the clinical point of contact for an indication or clinical study and represent the clinical matrix team at EDT or CMT. Collaborate with cross-functional teams to ensure cohesive translational and clinical development plans; act as Clinical Lead at the study level. Lead the end-to-end clinical development strategy for an EPU program and may contribute to later stages. Serve as primary clinical interface with internal RIIRU/GSK review boards and with external stakeholders (regulatory agencies, key opinion leaders, clinical investigators). Contribute to the clinical components of the Medicine Profile and gather inputs across disciplines to solve study and development plan challenges. Stay abreast of renal research advancements, trial methodologies, and regulatory developments to maintain GSK's competitive edge and identify transformational opportunities for patients. Support the integration of cross-disciplinary inputs and contribute to strategic initiatives within the EPU. Demonstrate the ability to influence others at project, departmental, and cross-functional levels as appropriate. Influencing and inspiring others: set a positive example, communicate a compelling vision, and create an environment where team members feel valued and motivated. Conflict management: demonstrate experience in managing conflicts effectively and negotiating mutually acceptable solutions. Influence skills: tailor communications to different audiences and use persuasive arguments to gain support. Enterprise mindset and navigating ambiguity: adapt to changing environments, analyze incomplete information, identify risks, and make informed decisions; collaborate across the matrix and balance team objectives with wider business goals; embrace challenges as opportunities for innovation; use digital tools to drive improvement. Qualifications
Basic Qualifications:
We are looking for professionals with these required skills: PhD or PharmD (or equivalent) with 13 years of postgraduate experience. Minimum of 3 years of experience in clinical research and development (may include postgraduate experience). Robust knowledge of renal-specific research priorities, public health needs, competitor landscape, clinical practice trends, and treatment guidelines. Experience working with global regulatory agencies and managing global clinical trials in nephrology. Knowledge of regulatory requirements, Good Clinical Practice (GCP), and ethical guidelines for clinical research. Demonstrated ability to work collaboratively in cross-functional teams and a matrix environment to design and execute trials to regulatory standards. Preferred Qualifications:
If you have the following characteristics, it would be a plus: Medical Degree and Board certification/eligibility in Nephrology Experience contributing to NDA, BLA or MAA submissions Why GSK?
Our values and expectations are at the heart of everything we do and are part of our culture. These include Patient focus, Transparency, Respect, Integrity, Courage, Accountability, Development, and Teamwork. 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 millions by the end of the decade, focusing on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases. We are committed to an agile working culture and a diverse, inclusive workplace. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants receive equal consideration for employment regardless of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military status, or any basis prohibited by law. If you require adjustments to our process to demonstrate your strengths, contact UKRecruitment.Adjustments@gsk.com or 0808 234 4391. The helpline is available 8:30am12:00 noon Monday to Friday; hours may vary on bank holidays. Please note that if your enquiry does not relate to adjustments, we may not be able to assist through these channels. A UK Recruitment FAQ guide is available in the Careers section for common questions. Important notice to Employment businesses/Agencies:
GSK does not accept referrals from employment businesses or agencies for vacancies posted on this site. All employment businesses/agencies must obtain prior written authorization from GSK before referring candidates. #J-18808-Ljbffr