Jonathan Leff

Board Member

2022 - Current

NorthSea is a clinical-stage biopharmaceutical company focused on the development of structurally engineered fatty acids, or SEFAs, for the treatment of metabolic diseases.

Executive Partner

2020

Board Member

2017

Independent Board member, Compensation Committee, Privately held. Avalyn Pharma develops improved therapies for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Board Member

2020 - 2021

Aerovate is a biotechnology company focused on developing drugs that meaningfully improve the lives of patients with rare cardiopulmonary disease

Senior Vice President and Chief Medical Officer

2016 - 2019

Built and managed leadership and oversight of all groups within company's clinical development organization, including clinical development, clinical operations, biometrics, regulatory, medical affairs, and pharmacovigilance functions. Served on Executive Staff providing company leadership both internal and external facing. • Designed and executed successful global Phase 3 trial in growth hormone deficiency. • Advanced second and third clinical assets into clinical development (INDs and equivalent). • Built group from two to an organization of 48 FTEs. • Integrated China and Japan into global development plans. • Coached and mentored numerous individuals.

Executive Vice President, Research and Development

2012 - 2015

Managed leadership and oversight of all groups within company's research and development organization, including research, development, regulatory, medical affairs, drug safety and pharmacovigilance, quality assurance, and project management. Worked to expand company’s product portfolio through support of business development activities. Oversaw budget of $110,000,000. • Led pristine execution of Phase 3 trial with FDA resubmission three months after unblinding. • Achieved approval of pirfenidone (Esbriet) for IPF in U.S. six weeks early with no Advisory Committee. • Developed and executed Early Access Program with over 1,600 patients. • Advanced pipeline with two IND-ready assets. • Supported successful EU, Canadian, and U.S. launches.

Chief Medical Officer

2011 - 2012

• Provided tactical and strategic leadership throughout the organization. • Led and redefined strategy on 3 products in the clinic • Rebuilt a high functioning Clinical Development Department with high morale and productivity. • Rescued a struggling oncology program with poor recruitment; now actively recruiting and progressing. • Active member of Series E financing team.

Vice President and Chief Medical Officer

2009 - 2010

-Clinical Development/Medical Affairs Head across all Halozyme franchises and products -Rescued oncology program with development issues; now recruiting and advancing in Phase 2 -Member of Senior Executive Team

Vice President, Global Head Inflammation Clinical Development

2007 - 2009

• Successfully defended Actemra at FDA Arthritis Advisory Board July 29, 2008 achieving 10-1 vote for approval. Currently approved in EU, US and several other countries • Manage a department at 4 international sites (Palo Alto, Nutley, Welwyn Garden City UK and Basel) • Completed complex worldwide line extension filing for Rituxan/MabThera in rheumatoid arthritis • Design and executed large Phase 3 program for ocrelizumab (humanized anti-CD20 antibody in rheumatoid arthritis and autoimmune diseases • Actively managed discovery and early development portfolio with DBLT, terminating numerous programs and in-licensing several molecules

Vice President

2007 - 2009

Roche is known by a number of different names. Same position as above.

Vice President - North America Medical Affairs

2002 - 2007

Held 3 positions of increasing responsibility culminating in VP North American Medical Affairs VP North American Medical Affairs: • Supported and grew 5 blockbuster brands (Neupogen, Neulasta, Epogen, Aranesp, Enbrel) • Created and standardized approaches to observation studies and analysis of pre-existing data to add value to brands • As member of Pipeline Steering Committee (with CEO and CEO direct reports), managed portfolio investments of Amgen development organization