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David Jacobs

@davidjacobs1

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I lead global clinical development programs through regulatory approval.

United States

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What I'm looking for

I'm seeking a Chief Medical Officer or senior clinical development leadership role where I can shape portfolio strategy, build high-performing organizations, lead global development through regulatory approval, and engage directly with boards, investors, and health authorities.

I've led clinical development and medical affairs across biotech and pharma for more than 25 years, spanning gene therapy, rare disease, CNS, immunology, rheumatology, and ophthalmology. At Tonix Pharmaceuticals, I direct late-stage development and lifecycle strategy across rheumatology, transplant/immunology, and neurology assets.

Previously, I owned ATX-304 clinical development at Betagenon and set strategy for four gene therapy programs at AGTC. As Chief Development Officer at Oculis, I held executive responsibility for CMC, regulatory affairs, clinical development, and clinical operations across the portfolio.

I've led Phase 1–4 programs through regulatory milestones, including two 505(b)(2) approvals, an eCTD NDA submission, and a $600M global Phase 3 program across 40 countries and 6,000 subjects. I build clinical organizations, own development budgets, and represent companies with FDA, EMA, boards, investors, KOLs, and safety monitoring boards.

Experience

Work history, roles, and key accomplishments

Vice President, Clinical Development

Tonix Pharmaceuticals

Sep 2025 - Jun 2026 (9 months)

Directed late-stage development and lifecycle management strategy across rheumatology, organ transplant/immunology, and neurology assets. Built standardized clinical development processes and managed a multi-disciplinary team.

Clinical Development Lifecycle Management Regulatory Strategy Team Management Portfolio Review Budgeting Individual Development Plans (IDPs)Target Product Profiles (TPPs)

Vice President, Clinical Development

Betagenon AB

Mar 2023 - Sep 2025 (2 years 6 months)

Owned end-to-end clinical development strategy for ATX-304, a novel AMPK activator in weight management. Authored foundational Phase I/II protocols and led medical monitoring and safety oversight.

Clinical Development Protocol Design Medical Monitoring Safety Oversight Regulatory Engagement DSMB Site Selection Recruitment Strategy

Senior Vice President, Clinical Affairs

AGTC (Applied Genetic Technologies Corporation)

May 2022 - Mar 2023 (10 months)

Set and executed clinical development strategy for four gene therapy programs. Held CMO-level scope across clinical affairs and pharmacovigilance, managing direct reports and consultants.

Gene Therapy Clinical Development Pharmacovigilance safety management PSURs DSURs Strategic Advisory Data Safety Monitoring

Chief Development Officer

Oculis SA

Sep 2020 - Oct 2021 (1 year 1 month)

Held full executive ownership of CMC, Regulatory Affairs, Clinical Development, and Clinical Operations. Led development of OCS-01 and OCS-02, delivering updates to CEO and Board.

Executive Leadership CMC Regulatory Affairs Clinical Development Clinical Operations Budget Management Vendor Selection Business Development KOL Engagement

Vice President, Clinical Development & Medical Affairs

Osmotica Pharmaceuticals PLC

Apr 2017 - Sep 2020 (3 years 5 months)

Led global Phase 3 programs in CNS and ophthalmology through to two 505(b)(2) approvals. Built and led a 7-person clinical operations organization and concurrently led Medical Affairs.

Clinical Development Medical Affairs Phase III 505(B)(2)Clinical Operations Budget Management MSL Advisory Board Payor Presentations

Senior Director, International Team Leader / Clinical & Frontier Development

Daiichi-Sankyo Pharmaceuticals

Jan 2013 - Dec 2017 (4 years 11 months)

Global project lead for a $600M, 6,000-subject, 40-country Phase 3 program (mirogabalin). Led a 35-person cross-functional team and all US/EU regulatory interactions.

Project Leadership Phase III Regulatory Interactions Cross functional Leadership Fibromyalgia Diabetic Neuropathy Post Herpetic Neuralgia

Senior Director, Clinical Development & Operations

Aptalis Pharmaceuticals

Jan 2011 - Dec 2013 (2 years 11 months)

Clinical lead for the Zenpep® Phase 3 registration program and PREA pediatric requirements for Rectiv®.

Clinical Development Phase III Pediatric Requirements Regulatory Affairs

Senior Director, Medical Affairs

King Pharmaceuticals / Pfizer

Jan 2010 - Dec 2011 (1 year 11 months)

Medical Development Leader for Oxecta® and Flector® patch, including Phase IIIb/IV strategy and labeling.

Medical Affairs Phase IIIb IV Labeling Product Development

Vice President, Clinical Development

Drais Pharmaceuticals

Jan 2009 - Dec 2009 (11 months)

Clinical and medical lead for two oncology candidates. Managed a QTc safety signal to resolution via protocol amendment and expert panel.

Oncology Clinical Development safety management Protocol Amendments Investor Presentations

Vice President, Clinical Research & Development

Cervelo Pharmaceuticals

Jan 2008 - Dec 2008 (11 months)

Took a DEA Schedule I analgesic from pre-IND meeting through IND submission and into Phase 1/2a. Presented quarterly to the Board of Directors and VC partners.

Clinical Research IND Submission Phase 1 2a Board Presentations Analgesic Development

Senior Director, Clinical Development

Progenics Pharmaceuticals

Jan 2006 - Dec 2008 (2 years 11 months)

Clinical lead for the methylnaltrexone eCTD NDA submission. Managed a 12-person clinical organization and led a multi-national Phase 3 program in post-operative ileus.

Clinical Development NDA And (E)CTD Submissions Phase III Team Management Post Operative Ileus

Senior Director, Clinical Development

NPS Pharmaceuticals

Jan 2004 - Dec 2006 (2 years 11 months)

Clinical lead for teduglutide registration studies in Short Bowel Syndrome and Phase I/II programs in CNS/psychiatric indications. Chaired the Protocol Approval Committee.

Clinical Development Registration Studies Phase I II Trials CNS Psychiatry Protocol Approval