Medical Director, Clinical Development, Advanced Pipeline Unit (APU) Respiratory

GSK

10d•$172,500 - $316,250•Onsite

About The Position

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, making sure that we focus 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. Find out more: Our approach to R&D GSK is seeking a Medical Director, Clinical Development, APU Respiratory to provide clinical and scientific insights to potential new, established and emerging assets in clinical development with a strong focus on respiratory disease You will work within project teams to plan, execute, and deliver clinical development activities and support medical governance up to and including registrational studies. This role is pivotal in driving GSK’s mission to deliver transformative medicines to patients, ensuring clinical excellence, regulatory compliance, and operational efficiency. About RIIRU: The Respiratory, Immunology and Inflammation Research Unit (RIIRU) was formed in 2024 to identify and advance novel molecular targets with genetic associations to disease based on the foundational observation that targets with human genetic evidence supporting their causal role in the intended indication improves clinical success by two-fold. The remit of RIIRU is to identify novel targets based on human genetics, develop assets for clinical studies, and perform trials through to submission for approvals. This goal is enabled through strategic external (e.g., Flagship Pioneering, Vesalius, Muna Therapeutics and others) and GSK-internal partnerships (Research Technologies). PLEASE NOTE: This career opportunity requires an on-site office presence (minimum of two days a week) at one of GSK’s US (PA or MA) or UK (Stevenage or London HQ) sites.

Requirements

Medical Degree
Completion of a formal postgraduate clinical training, clinical residency or specialty training in Internal Medicine or Primary Medical
Completion of full clinical training/residency leading to board eligibility or certification
Experience in clinical research and drug development, with a focus on respiratory diseases.

Nice To Haves

Medical degree and clinical medical specialty training board qualification/registration in Pulmonary Medicine/Pulmonary & Critical Care or Respiratory Medicine.
Experience in the global pharmaceutical/biotechnology industry in respiratory diseases
Experience in leading NDA, BLA, or MAA submissions and managing global clinical trials.
Experience in late-stage respiratory disease drug development, including Phase 2 and Phase 3 clinical trial design, initiation, execution, and closure

Responsibilities

Contribute to project team discussions on indication planning and incorporate input from across disciplines (scientific, clinical, commercial, regulatory, stats, etc) to support vital deliverables including the Target Medicine Profile (TMP), clinical development plan (CDP), study protocols, and integrated evidence strategy (IES) and planning.
Provide effective support to the development and execution of the IES, including oversight of R&D evidence generation activities to ensure patient safety and study delivery.
Design and execute clinical development plans across advanced stages of development, reflecting internal and external stakeholder input (ie patients, evidence generation, regulators, payors, pharmacovigilance, etc.).
Contribute to ambitious clinical development timelines by overseeing development of clinical study protocols, amendments, investigator brochures, clinical study reports etc.
Input to, and may lead, 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.
Act as clinical lead for a clinical study, taking a key role on the Study Leadership Team (SLT) and serve as clinical point of contact for a clinical study on the Clinical Matrix Team (CMT), across the internal matrix and a broad range of external experts (e.g., regulators, payors, CROs, consultants, investigators).
Make significant contributions to global regulatory submissions/files (e.g., IND, NDA, BLA, MAA), including briefing documents, presentations, and responses to regulatory questions.
Evaluate specific business development activities, including due diligence and contributes to the implementation and embedding of strategic/organizational initiatives in Clinical Development, adopting innovative methodologies and processes including digital tools and technology.
Stay abreast of advancements in therapeutic area research, clinical trial methodologies, competitive environment, and regulatory space to maintain GSK’s competitive edge.
Demonstrate flexibility and adaptability in changing environments and ability to analyze incomplete information, identify potential risks and implications, and make informed decisions.
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.
Embrace challenge as an opportunity, proactively generating ideas for innovative improvement and promoting an environment for others to be creative.
Manage conflicts effectively and independently, negotiating mutually acceptable solutions.
Analyze, interpret and critically evaluate data, information and digital content to interpret complex information, anticipate obstacles and identify potential solutions.
Consistently achieve 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.