Clinical Development Senior Medical Director - Vascular

GSK•Upper Providence, PA

3d•$284,625 - $474,375•Hybrid

About The Position

This role will lead clinical development medical activities for vascular programmes across early and later phase studies. The successful candidate will work closely with colleagues in clinical operations, translational science, regulatory, safety, and commercial teams, valuing clear clinical judgement, collaborative leadership and a focus on patient impact. The role involves shaping clinical plans that accelerate safe, meaningful medicines to people with vascular disease while growing your career and influence at GSK. The position is within the Cardiovascular Medicine group in GSK’s Respiratory, Immunology & Inflammation Research Unit, focusing on translation and early clinical development of programmes in heart failure and atherosclerotic disease, particularly in people with comorbid chronic inflammatory disease. Responsibilities include providing clinical and scientific leadership to clinical and translational studies or programmes for asset-level projects, contributing to the assessment of potential mechanisms and targets, target validation programs, life-cycle expansion, and innovative clinical development opportunities. The role also involves cross-functional collaboration to develop and execute clinical development plans (CDPs) and contribute to above-project development of foundational and real-world data, and translational and biomarker capabilities.

Requirements

Medical degree
Board registration /certification /eligibility in cardiovascular medicine disease, vascular medicine or related specialty.
Minimum of 5 years of experience in clinical research and development
Knowledge of and experience in the execution of translational studies including both generation and analysis of human translational data and conduct of preclinical biological experiments in relevant model systems
Robust knowledge of cardiovascular medicine research priorities, public health needs, competitor landscape, clinical practice trends and treatment guidelines evolution.
Experience working with global regulatory agencies and managing global clinical trials in relevant disease area.
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.

Nice To Haves

PhD in addition to medical degree
Experience in contributing to IND/CTA, NDA, BLA, or MAA submissions

Responsibilities

Lead the formulation of translational and clinical plans and study designs with project strategies to ensure quality design and execution of the CDP.
Develop sections of core regulatory documents.
Generate the data and evidence required to determine a target’s potential efficacy, safety profile, key areas of differentiation and route to becoming a medicine with value to patients in the shortest possible timeframe.
Define and deliver the clinical pillars of the translational table.
Deliver clinical development and study timelines and endpoints, including pharmacology, mechanism and clinical efficacy endpoints, enabling key decision points and go/no-go criteria for the CDP.
Establish and maintain relationships with program counterparts in biology, translational sciences, commercial, regulatory, 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 and experienced support and oversight of R&D evidence generation strategy, plan and activities to ensure patient safety and on-time, in-full study delivery.
Contribute to the study team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc.) to contribute to vital deliverables including early medicine profile, target validation, translational plans, candidate selection.
Lead the design of clinical development plans, study protocols and associated documents across all phases of development, reflecting internal and external stakeholder input (e.g., patients, evidence generation, regulators, payors, pharmacovigilance), with an emphasis on early development.
Bring clinical expertise to regulatory interactions and documents including briefing documents, presentations, addressing questions and responses for assigned studies and programs.
Provide medical monitoring and oversight of the safety of study participants on behalf of the sponsor during the study, together with pharmacovigilance physician.
Accountable for medical governance across the project to ensure scientific integrity and overall safety of the study subjects across the study.
Accountable for leading the clinical matrix team (CMT) for a program.
Serve as a clinical point of contact both internally and externally for an indication of an asset or for a clinical study, and represent the CMT at early/medicine development teams.
Actively lead the end-to-end clinical development strategy for an early program and may contribute to later stages.
Serve as the primary clinical point of contact for an investigational agent (early development) or clinical study for internal and external stakeholders, including regulatory agencies, key opinion leaders, and clinical investigators and with the relevant internal review boards (e.g., technical review or governance) and/or Protocol Review Board.
Lead clinical evaluation of business development opportunities.
Remain abreast of advancements in research, clinical trial methodologies, competitive environment and regulatory space in the relevant disease area to maintain GSK’s competitive edge, and disseminate information about recent advances to the relevant GSK colleagues.
Identify and highlight transformational opportunities for GSK program, for example where projects can offer highly significant benefit to patients in ways not possible with existing approaches.
Oversee the gathering and support the integration of inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to clinical components of the medicine profile.
Consistently contribute to solving study and overall clinical development challenges, including leading through others.
Demonstrate ability to lead and influence others at project, departmental and inter-departmental levels, as appropriate.
Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovative approaches to science and technical solutions.
Promote an environment for others to generate ideas for improvement and proactively drives innovation, beyond taking advantage of opportunities that arise.
Consistently achieves desired outcomes through strong influencing skills including understanding others' perspectives, building trust, tailoring communications depending on the audience and using persuasive arguments to gain support.
Able to consistently inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated.
Manage conflicts effectively and independently, negotiating mutually acceptable solutions.
Demonstrate enterprise mindset with effective collaboration across the matrix, able to integrate cross-functional knowledge into decision-making processes and balance team objectives with the wider business goals.
Analyses, interprets and critically evaluates data, information and digital content to interpret complex information, anticipate obstacles and identify potential solutions.
Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete information, identify potential risks and implications, and make informed decisions.