Clinical Development Medical Director - Cardiovascular
Core
Lead clinical development strategy and study design for cardiovascular asset-level projects, ensuring quality execution of clinical development plans (CDPs) and generating evidence for target efficacy and safety.
Role type
Senior IC Clinical Development Medical Director
Builds
Clinical development plans, study protocols, regulatory documents, and evidence packages for cardiovascular medicines.
Domain
Biopharmaceuticals / Cardiovascular
Required skills
Clinical development strategy, study design, regulatory document development, medical monitoring, cross-functional collaboration, stakeholder management, scientific integrity, project leadership, competitive landscape analysis, innovation in clinical approaches
Preferred skills
Experience in early to late-stage development, knowledge of translational science, ability to influence cross-functional teams, understanding of real-world data and biomarkers
Technologies
Clinical trial methodologies, digital tools for scientific solutions, regulatory briefing tools
Responsibilities
Support alignment of translational and clinical plans with project strategies; Generate data and evidence for target potential efficacy and safety; Define and deliver clinical pillars of the translational table; Deliver clinical development timelines and endpoints; Establish relationships with program counterparts in Biology, Translational Sciences, Commercial, Regulatory, Clinical Operations, Market Access, Medical Affairs and Statistics; Provide oversight of R&D evidence generation strategy; Design clinical development plans and study protocols; Provide medical monitoring and oversight of study participant safety; Accountable for medical governance across the project; Lead the Clinical Matrix Team (CMT) for a program; Serve as primary Clinical point of contact for internal and external stakeholders; Assist with clinical evaluation of business development opportunities; Stay abreast of advancements in research and regulatory space; Identify transformational opportunities for patient benefit; Gather and integrate inputs from across disciplines to contribute to the Medicine Profile; Solve study and overall clinical development challenges; Demonstrate ability to influence others at project, departmental and inter-departmental levels; Embrace challenge as an opportunity for creativity and use new learning and digital tools to create innovative approaches; Promote an environment for others to generate ideas for improvement; Manage conflicts effectively and independently; Demonstrate enterprise mindset with effective collaboration across the matrix
Seniority
Senior, hands-on IC