Kiran Bhirangi

Chief Medical Officer and influential company leader partnering with the board of directors, investors, and key stakeholders to drive scientific and business opportunities. As a forward-thinking business strategist, I have led the design and successful delivery of clinical development and medical affairs for global organizations spanning the US, EU, EMEA, and APAC. Recognized as a trailblazer, I have a track record of success in building environments for the commercialization of new products for medical device, specialty pharma and rare disease biotech. With an entrepreneurial mindset, I am accustomed to establishing vision and mission, building organizational infrastructure, recruiting and developing diverse professional teams, and creating a patient-centered cultural environment delivering world-class outcomes. As a collaborative and fair leader, I have consistently created an efficiently operating cohesive culture by aligning the right people in the right jobs. I have recruited, developed, and inspired top-performing professionals to drive the organization’s mission and business goals. I’m driven by the commitment to patient care and safety. My Breadth of Medical Leadership Expertise Spans: • Establishing/transforming Global Medical and Clinical organizations • Instituting infrastructure and governance • Negotiating with investors, boards of directors, regulators, investigators, and scientific advisory boards • Identifying and managing licensing deals and global funding opportunities • Staffing medical-clinical groups (MSL, publications, medical info & safety/PV) and KOL Advisory boards) • Leading product launches & commercialization (Rare disease; Cardiology; anti-infective products; hematology; and medical devices) • Launching and managing clinical trials worldwide (US, EU, India, Latin America, China) • Cultivating investigator and CRO, patient support group relationships • Developing and managing KOL relationship strategies for USA, EMEA, Canada and Rest of the World Expertise Spans: • Multiple therapeutic areas • NDA, sBLA, MAA and FDA difficult clinical hold negotiations • Phase 1, 2, 3 (and 3b) and 4 protocols with drug and appropriate phase studies for devices • Device and drug device combinations (launch, IDE, PMA, 510K, CE mark and evaluation) • Clinical Dev Plan for Biologic, small molecules, IDE for devices 510K and PMA • Global regulatory filings (US FDA; EMA; Israel, Brazil, Mexico, Switzerland and Canada) • Reimbursement • HEOR trials and registry development and PASS