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 intranslational medicine and early clinical developmentin vascular &relateddisease:

• Providescientific and clinical leadershiptostrengthen RIIRUs capabilities in translation and early clinical developmentprograms that modulate inflammation and endothelial dysfunctionusing a range of drug modalities including oligonucleotidesbiologicsand small molecules.

• Act as a subject matter expert in clinical development drugs that modulate inflammation and endothelial dysfunction.

• Support thedesignoftranslational and clinical plansthatsupportproject strategy.Support theexecution ofhigh-qualityevidence-gathering and clinical development plansthatoffer swift paths tonew safe and effective medicines.Leaddevelopment of clinicalsections of core regulatory documents.

• Contribute tothe design and execution of clinical studies that generate the data and evidencetodeterminea 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 possibletimeframe. This includes designingand deliveringthe clinicalelements of a translational strategy and designingand deliveringclinical development and study timelines and endpoints including pharmacologymechanismand clinical efficacy endpoints enabling key decision points andgo/no-go criteria for theclinical development plan.

• Seekbuildandmaintainrelationships with program counterparts inbiologytranslationalcommercialresearch technologiesregulatory affairsclinical operationsmarket accessmedicalaffairsandstatistics.

• Contribute tothe implementation and embedding of strategic initiatives and variousorganizationalinitiatives inclinical development

Contribute toclinicaldevelopment strategyprogramand studydesign:

• Provide effective support and oversight ofR&D evidence generation activities to assure patient safety and study delivery.

• Contribute tostudy team discussions onindicationplanningincorporates input from across disciplines (e.g. biology clinical commercial regulatory statistics) to contribute to vital deliverables including earlymedicine profiletarget validationtranslational planscandidate selection.

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

• Developother asset- and study-related documents including protocolamendments investigator brochures clinical study reports.

• Provideclinical inputto regulatory interactions and documentsand responses to regulatory feedbackfor assigned studies and programs.

• Provide medical monitoring and oversight of the safety of study participants on behalf of thesponsorduring the study together withpharmacovigilance physician.Ifyou areaphysicianthis includesaccountability formedical governanceacross the project to ensure scientific integrity and overall safety of the studyparticipants.

Be a clinical leader:

• Be accountablefor leading theclinical 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)forone or moreassetorindicationor for a clinical study. Represent the clinical matrix team atthe early development team (EDT)or clinical study at CMT.

• Activelycollaborateto design and deliverthe end-to-end clinical development strategy forone or moreEPU programsand may contribute to laterclinical developmentstages.

• Serve as the primary clinical interface with the relevant internal RIIRU/GSKgovernancereview boardsandprotocolreview board.

• Contribute toclinicalevaluation of business development opportunities.

• Gather and support the integration of inputs from across disciplines (scientific clinicalcommercial regulatory) tocontribute toclinical components of themedicine profile. Consistentlycontribute tothesolvingofstudy and overall clinical development plan problems.

• Demonstrate ability to influence others at project departmental and inter-departmental levels asappropriate.

Influenceandinspireothersandmanageconflict:

• Consistentlyinspire 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 andnavigateambiguity:

• Demonstrate flexibility and adaptability in changing environments able to analyze incompleteor impreciseinformationidentifypotential 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 teamobjectiveswith the wider business goals.

• Embrace challenge as an opportunity for creativity and uses new learning and digital tools to create innovation in other areas

• Proactivelygenerateideas 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 medicineallied toone or more internal medicine specialty(e.g. cardiologymetabolic medicinenephrology hepatology neurology)either in a clinical academic setting or in a biotech or pharma organization.

• Involvement incross-functionalmatrixteamsdesigning andexecuting clinical trialsto 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