Clinical Development Medical Director- Vascular

Key Accountabilities / Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following

Be an expert in translational medicine and early clinical development in vascular & related disease:

• 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. This includes designing and delivering the clinical elements of a translational strategy and designing and delivering 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 clinical development plan.

• 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

Contribute to clinical development strategy, program and study design:

• 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, incorporates input from across disciplines (e.g. biology, clinical, commercial, regulatory, statistics) to contribute to vital deliverables including early medicine profile, target validation, translational plans, candidate selection.

• Design clinical development plans and study protocols across all phases of development - with a focus on phases 1 and 2 - reflecting internal and external stakeholder input (e.g. patients, evidence generation, regulators, payors, pharmacovigilance).

• Develop other asset- and study-related documents, including protocol amendments, investigator brochures, clinical study reports.

• 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 on behalf of the sponsor during the study, together with pharmacovigilance physician. If you are a physician, this includes accountability for medical governance across the project to ensure scientific integrity and overall safety of the study participants.

Be a clinical leader:

• Be accountable for leading the clinical matrix team (CMT) on EPU programs. Serve as a clinical point of contact both internally and externally (e.g. regulatory agencies, academic collaborators, investigators, external experts) for one or more asset or indication, or for a clinical study. Represent the clinical matrix team at the early development team (EDT) or clinical study at CMT.

• Actively collaborate to design and deliver the end-to-end clinical development strategy for one or more EPU programs and may contribute to later clinical development stages.

• Serve as the primary clinical interface with the relevant internal RIIRU/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 (scientific, clinical, commercial, regulatory) to contribute to clinical components of the medicine profile. Consistently contribute to the solving of study and overall clinical development plan problems.

• Demonstrate ability to influence others at project, departmental and inter-departmental levels, as appropriate.

Influence and inspire others, and manage conflict:

• Consistently inspire others by setting a positive example, communicating a compelling vision, and creating an environment where team members feel valued and motivated.

• Demonstrate experience in managing conflicts effectively and independently, negotiating mutually acceptable 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.

Have an enterprise mindset and navigate ambiguity:

• Demonstrate flexibility and adaptability in changing environments, able to analyze incomplete or imprecise 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 for creativity and uses new learning and digital tools to create innovation in other areas

• Proactively generate ideas for innovative improvement and takes advantage of opportunities that arise; promotes environment for others to generate ideas for improvement

• Medical degree from accredited medical school

• Completion of a clinical residency program

• Experience in clinical research and development

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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 specialty (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