GlaxoSmithKline
Clinical Development Medical Director- Vascular
GlaxoSmithKline, Boston, Massachusetts, us, 02298
Position Summary
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, focusing 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.
Key Accountabilities / Responsibilities
Provide scientific and clinical leadership to strengthen RIIRU’s capabilities in translation and early clinical development programs that modulate inflammation and endothelial dysfunction using a range of drug modalities, including oligonucleotides, biologics and small molecules.
Act as a subject matter expert in clinical development drugs that modulate inflammation and endothelial dysfunction.
Support the design of translational and clinical plans that support project strategy.
Support the execution of high‑quality evidence‑gathering and clinical development plans that offer swift paths to new safe and effective medicines.
Lead development of clinical sections of core regulatory documents.
Contribute to the design and execution of clinical studies that generate the data and evidence required to determine a target or medicines’ potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe, including design and delivery of the clinical elements of a translational strategy and development of clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and go‑no‑g criteria.
Seek, build and maintain relationships with program counterparts in biology, translational, commercial, research technologies, regulatory affairs, clinical operations, market access, medical affairs and statistics.
Contribute to the implementation and embedding of strategic initiatives and various 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, including input from across disciplines (e.g. biology, clinical, commercial, regulatory, statistics).
Design clinical development plans and study protocols across all phases of development—focusing on phases 1 and 2—reflecting internal and external stakeholder input.
Develop other asset‑ and study‑related documents, including protocol amendments, investigator brochures, clinical study reports, etc.
Provide clinical input to regulatory interactions and documents and responses to regulatory feedback for assigned studies and programs.
Provide medical monitoring and oversight of the safety of study participants.
Be a clinical leader: accountable for leading the clinical matrix team on EPU programs; serve as a clinical point of contact internally and externally.
Actively collaborate to design and deliver the end‑to‑end clinical development strategy for EPU programs and may contribute to later clinical development stages.
Serve as the primary clinical interface with the relevant internal GSK governance review boards and protocol review board.
Contribute to clinical evaluation of business development opportunities.
Gather and support the integration of inputs from across disciplines to solve clinical components of the medicine profile.
Demonstrate ability to influence others at project, departmental and inter‑departmental levels.
Influence and inspire others, manage conflict, and maintain a positive team environment.
Have an enterprise mindset, navigate ambiguity, and collaborate across the matrix to balance team objectives with wider business goals.
Embrace challenge as an opportunity for creativity, use new learning and digital tools to create innovation in other areas.
Proactively generate ideas for innovative improvement and take advantage of opportunities that arise; promote an environment for others to generate ideas for improvement.
Basic Qualifications
Medical degree from an accredited medical school.
Completion of a clinical residency program.
Experience in clinical research and development.
Preferred Qualifications
Board certification in internal medicine, cardiology, clinical pharmacology or a related specialty.
Deep understanding of vascular medicine or vascular biology.
Experience in translational and clinical research in vascular medicine allied to one or more internal medicine specialties (e.g. cardiology, metabolic medicine, nephrology, hepatology, neurology) either in a clinical academic setting or in a biotech or pharma organization.
Involvement in cross‑functional matrix teams designing and executing clinical trials to relevant regulatory standards.
Experience in contributing to NDA, BLA or MAA submissions.
Knowledge of regulatory requirements, Good Clinical Practice (GCP) and ethical guidelines for clinical research.
Salary and Benefits For U.S. locations: $202,500 to $337,500 for a new hire. For Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: $222,750 to $371,250. Salary ranges reflect work location, skills, experience, education and market rate. The role offers an annual bonus, eligibility for a share‑based long‑term incentive program, health care, retirement benefits, paid holidays, vacation, and caregiver/parental and medical leave.
Why GSK? 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. 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.
Equal Opportunity Employer GSK is an Equal Opportunity Employer. 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, state or local law.
Contact for adjustments: UKRecruitment.Adjustments@gsk.com
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Key Accountabilities / Responsibilities
Provide scientific and clinical leadership to strengthen RIIRU’s capabilities in translation and early clinical development programs that modulate inflammation and endothelial dysfunction using a range of drug modalities, including oligonucleotides, biologics and small molecules.
Act as a subject matter expert in clinical development drugs that modulate inflammation and endothelial dysfunction.
Support the design of translational and clinical plans that support project strategy.
Support the execution of high‑quality evidence‑gathering and clinical development plans that offer swift paths to new safe and effective medicines.
Lead development of clinical sections of core regulatory documents.
Contribute to the design and execution of clinical studies that generate the data and evidence required to determine a target or medicines’ potential efficacy, safety profile, key areas of product differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe, including design and delivery of the clinical elements of a translational strategy and development of clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and go‑no‑g criteria.
Seek, build and maintain relationships with program counterparts in biology, translational, commercial, research technologies, regulatory affairs, clinical operations, market access, medical affairs and statistics.
Contribute to the implementation and embedding of strategic initiatives and various 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, including input from across disciplines (e.g. biology, clinical, commercial, regulatory, statistics).
Design clinical development plans and study protocols across all phases of development—focusing on phases 1 and 2—reflecting internal and external stakeholder input.
Develop other asset‑ and study‑related documents, including protocol amendments, investigator brochures, clinical study reports, etc.
Provide clinical input to regulatory interactions and documents and responses to regulatory feedback for assigned studies and programs.
Provide medical monitoring and oversight of the safety of study participants.
Be a clinical leader: accountable for leading the clinical matrix team on EPU programs; serve as a clinical point of contact internally and externally.
Actively collaborate to design and deliver the end‑to‑end clinical development strategy for EPU programs and may contribute to later clinical development stages.
Serve as the primary clinical interface with the relevant internal GSK governance review boards and protocol review board.
Contribute to clinical evaluation of business development opportunities.
Gather and support the integration of inputs from across disciplines to solve clinical components of the medicine profile.
Demonstrate ability to influence others at project, departmental and inter‑departmental levels.
Influence and inspire others, manage conflict, and maintain a positive team environment.
Have an enterprise mindset, navigate ambiguity, and collaborate across the matrix to balance team objectives with wider business goals.
Embrace challenge as an opportunity for creativity, use new learning and digital tools to create innovation in other areas.
Proactively generate ideas for innovative improvement and take advantage of opportunities that arise; promote an environment for others to generate ideas for improvement.
Basic Qualifications
Medical degree from an accredited medical school.
Completion of a clinical residency program.
Experience in clinical research and development.
Preferred Qualifications
Board certification in internal medicine, cardiology, clinical pharmacology or a related specialty.
Deep understanding of vascular medicine or vascular biology.
Experience in translational and clinical research in vascular medicine allied to one or more internal medicine specialties (e.g. cardiology, metabolic medicine, nephrology, hepatology, neurology) either in a clinical academic setting or in a biotech or pharma organization.
Involvement in cross‑functional matrix teams designing and executing clinical trials to relevant regulatory standards.
Experience in contributing to NDA, BLA or MAA submissions.
Knowledge of regulatory requirements, Good Clinical Practice (GCP) and ethical guidelines for clinical research.
Salary and Benefits For U.S. locations: $202,500 to $337,500 for a new hire. For Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA: $222,750 to $371,250. Salary ranges reflect work location, skills, experience, education and market rate. The role offers an annual bonus, eligibility for a share‑based long‑term incentive program, health care, retirement benefits, paid holidays, vacation, and caregiver/parental and medical leave.
Why GSK? 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. 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.
Equal Opportunity Employer GSK is an Equal Opportunity Employer. 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, state or local law.
Contact for adjustments: UKRecruitment.Adjustments@gsk.com
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