Head of development operations for cardiology program evaluating cardiac myosin modulators for the treatment of patients with hypertrophic cardiomyopathy and and other serious diseases of cardiac diastolic dysfunction. Initiating first-in-human and first-in-patient studies for EDG-7500.

Clinical development for a privately-held, clinical-stage biopharmaceutical company pioneering novel approaches for the treatment of cardiovascular conditions by the inhalation route.

Clinical research and development lead for a small biopharma company focused on precision medicine based cardiovascular therapies. Designed and analyzed an adaptive, seamless Phase 2b/3, comparative efficacy trial investigating bucindolol hydrochloride for the prevention of atrial fibrillation in a genotype-defined heart failure population. Recruited and managed team responsible for all clinical research and operations activities. Developed protocols, investigator brochures, statistical analysis plans, and other study related documents. Negotiated program requirements and Special Protocol Assessment agreement with FDA and ex-US regulatory agencies. Responsible for clinical budgets, program timelines, vendor selection/management, data analyses and publications. Company liaison with investigators, medical advisory committees and corporate partners.

Independent consultant providing clinical, regulatory, and business development strategies to the pharmaceutical and biotech industries. Past projects include: clinical, regulatory, and business development for a start-up company focused on targeted radiopharmaceutical drug-device therapies for locally-advanced cancers; protocol design, regulatory and clinical operations for Phase 2/3 cardiovascular program (heart failure/atrial fibrillation); protocol development for several biomarker-directed biologics (idiopathic pulmonary fibrosis, pulmonary hypertension); protocol development and publications (pulmonary hypertension).

Project leader responsible for a cross-functional team that provided strategic and tactical recommendations to senior management for the post-launch development of ambrisentan. Developed comprehensive Phase 4 development plan to leverage product strengths and expand commercial adoption, including design of a major event-driven outcomes study in PAH. Guided regulatory strategy for post-approval commitments and labeling, including safety submissions that eliminated unwarranted black box warnings and a pediatric development plan designed to extend market exclusivity. Provided medical affairs support, including commercial advisory board presentations, assessment of investigator sponsored trial proposals, and development of medical information response documents. Produced clinical assessments of cardiovascular in-licensing opportunities, performed due diligence, and created development plans for potential new products. Created and executed long-term publication strategy, assigned projects, maintained timelines and deliverables, and mentored writers.

Directed a team of internal clinical scientists, external vendors, and contract medical writers who were responsible for creating 11 clinical study reports and five CTD clinical summary/overview sections in less than one year. Assigned projects, created timelines, led scientific reviews, and wrote or edited all clinical sections of the NDA. Successfully petitioned for Fast Track designation and Priority Review, which led to the accelerated FDA approval of ambrisentan (Letairis®) for the treatment of pulmonary arterial hypertension. Guided strategy for regulatory responses and label negotiations with the Division of Cardio-Renal Drug Products. Trained a newly-hired medical science, sales, and marketing staff in advance of commercial launch. Served as the primary clinical liaison for a corporate partnership with GlaxoSmithKline which acquired ex-US rights for ambrisentan. Developed publication strategy and wrote/edited numerous abstracts, manuscripts, and reviews. Provided clinical support for commercial development and marketing, including branding, KOL development, and in-license/out-license opportunities.

Designed, authored, and executed multiple clinical study protocols and amendments (Phase 1-3). Participated in teleconference and face-to-face meetings with the FDA and functioned as the primary company liaison with key opinion leaders and steering committee members. Developed statistical analysis and data management plans. Wrote/edited numerous regulatory documents, including FDA/EMEA briefing documents, IRB/EC responses, IND annual reports, and investigator brochures. Executed clinical operations responsibilities, such as investigator meeting presentations, site evaluation and initiation visits, clinical drug supply management, informed consent approvals, enrollment tracking, and laboratory reviews. Analyzed clinical study results and wrote clinical study reports, meeting abstracts, and peer-reviewed manuscripts.

Performed clinical pharmacology research in patients receiving high-dose chemotherapy in conjunction with autologous bone marrow transplantation or hematopoietic stem cell support. Supported Phase 1-3 clinical oncology trials, conducted pre-clinical animal studies, and performed pharmacokinetic modeling for both clinical and animal studies. Conducted clinical research focused on the use of radionuclide-conjugated antibodies for the treatment of advanced breast cancer.