Andreas Minke

About

Senior biopharmaceutical executive with 15+ years of progressive leadership across project and program management, and portfolio governance in small biotechnology and large pharmaceutical companies. Track record includes successful filings of FDA IND and EU CTR applications, FDA Breakthrough Therapy Designation, CPRIT/NIH research funding, and end-to-end leadership of Phase 2/3 programs across multiple therapeutic areas.

Experience

• Vice President, Program Management · Immunovant05-01-2024 – 05-01-2026

  ● Led global programs in endocrinology (TED), rheumatology (RA) and dermatology (CLE), managing cross-disciplinary teams across clinical, regulatory, CMC, and commercial functions. ● Built and scaled cross-functional PMO infrastructure for IMVT-1402 pipeline as program transitioned from early to late-stage development. ● Managed cross-functional teams to successfully submit multiple INDs and EU CTR applications across new indications for IMVT-1402.

• Senior Director, Program Management · Immunovant04-01-2023 – 05-01-2024

  ● Led global programs in endocrinology (TED), rheumatology (RA) and dermatology (CLE), managing cross-disciplinary teams across clinical, regulatory, CMC, and commercial functions. ● Built and scaled cross-functional PMO infrastructure for IMVT-1402 pipeline as program transitioned from early to late-stage development. ● Managed cross-functional teams to successfully submit multiple INDs and EU CTR applications across new indications for IMVT-1402.

• Director, Project Management · Immunovant06-01-2021 – 02-01-2022

  ● Led cross-functional efforts to resume batoclimab Phase 3 development after voluntary clinical pause due to lipid safety findings

• Vice President, Program & Alliance Management · OncoNano Medicine02-01-2023 – 04-01-2023

  ● Led end-to-end program management for pegsitacianine, an adjunct intraoperative optical imaging agent, and ONM-501, a dual-activating polyvalent STING agonist ● Managed strategic public-private alliances with the U.S. National Institutes of Health (NIH), Cancer Prevention & Research Institute of Texas (CPRIT), and UT Southwestern, successfully managing over $30M in competitive research funding. ● Received FDA Breakthrough Therapy designation for pegsitacianine as adjunct in peritoneal carcinomatosis surgery and activated IND for ONM-501 Phase 1 clinical trial.

• Senior Director, Project & Program Management · OncoNano Medicine02-01-2022 – 02-01-2023

  ● Led end-to-end program management for pegsitacianine, an adjunct intraoperative optical imaging agent, and ONM-501, a dual-activating polyvalent STING agonist ● Managed strategic public-private alliances with the U.S. National Institutes of Health (NIH), Cancer Prevention & Research Institute of Texas (CPRIT), and UT Southwestern, successfully managing over $30M in competitive research funding. ● Received FDA Breakthrough Therapy designation for pegsitacianine as adjunct in peritoneal carcinomatosis surgery and activated IND for ONM-501 Phase 1 clinical trial.

• Head of R&D Portfolio Management Operations · Galderma09-01-2020 – 06-01-2021

  ● Implemented stage-gate decision model across integrated R&D organization, improving pipeline governance consistency and decision-making speed ● Appointed secretary of the corporate pipeline governance committee; managed agenda, ensured factual presentations, and tracked follow-up actions ● Delivered long-range R&D investment plan supporting multi-year portfolio prioritization.

• Head of Global Project Management · Galderma01-01-2016 – 09-01-2020

  ● Oversaw governance and long-term R&D investment strategy for global pipeline. ● Managed full lifecycle programs (from early to late stage) including NEMLUVIO® and AKLIEF®. ● Implemented new PMO processes, methodologies, tools, and infrastructure following company-wide restructuring.

• Head of Global Quality Operations Surgical · Alcon (a Novartis Company)08-01-2014 – 01-01-2016

  ● Implemented electronic quality systems (CAPA, Change Control, Training) globally across nine medical device manufacturing sites. ● Prepared and supported manufacturing sites for successful FDA inspections. ● Developed strategic investment roadmap following a global benchmarking of surgical manufacturing operations.

• Strategic Advisor to the CEO and Executive Team · Alcon (a Novartis Company)10-01-2012 – 08-01-2014

  ● Orchestrated division-wide restructuring and product acceleration strategies with >$100M impact. ● Designed dashboards and planning models for global decision-making. ● Facilitated monthly executive team meeting, streamlining agendas and ensuring consistent follow-through on action items.

• Associate Director, Portfolio & Project Management · Alcon (a Novartis Company)04-01-2009 – 09-01-2012

  ● Spearheaded integration of new planning processes; led 5 early-stage assets from candidate selection to proof-of-concept Phase 1/2 clinical trials. ● Directed annual strategic plan submissions and milestone reviews.

Education

• Southeast Missouri State UniversityMaster of Business Administration
• Hogeschool ZuydBachelor of Arts

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