Philip Johnson Email & Phone Number

New York, Ny, Us

Indianapolis, Indiana, Us

I lead the Early Oncology Development organization for Lilly, inclusive of Project Leadership & Management, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Medical Writing, and Business Operations functions, with responsibilities spanning from IND filings through NDA/BLA approvals and lifecycle development.

Stamford, Ct, Us

I led a team of 20 Regulatory and Medical Writing professionals supporting all Loxo@Lilly oncology programs from discovery through NDA/BLA approval. Key Regulatory responsibilities included IND filings and coordination of rest-of-world CTA filings, development and alignment of regulatory strategies with internal stakeholders and external regulators to support accelerated regulatory filings and approvals, NDA/BLA submissions, and regulatory policy. Key Regulatory Companion Diagnostics responsibilities included strategic CDx/Dx regulatory interactions including study risk determinations (SRD), IDEs, pre-sub consultation, and scientific advice, and partnerships with external Dx partners to align co-development activities.Key Medical Writing activities included development of all clinical documents including protocols, investigator brochures, protocol amendments, clinical study reports, Module 2 summaries, and Assessment Aids.

New York, New York, Us

At Pfizer, I led the Medicine Team in the submission & approval of Daurismo (glasdegib) by FDA & EMA for acute myeloid leukemia, as well the approval of Besponsa (inotuzumab ozogamicin) by FDA & EMA for acute lymphoblastic leukemia, in addition to multiple life-cycle development programs for those medicines. I have also led an immuno-oncology program in head & neck cancer.As a Medicine Team Leader, I was accountable for driving the strategy, implementation and successful delivery of the integrated Medicine Plan for Oncology compounds in late phase development. Responsibility for these assets begins after achievement of Proof of Concept, and covered the period including pivotal registration development, subsequent registrations, post-approval trials & life-cycle management. I was responsible for ensuring timely execution and delivery of new and ongoing clinical trial programs that had a high likelihood of technical, regulatory and commercial success. I led the Global Medicine Team and aligned with associated subteams to ensure cross-functional alignment in support of the assigned assets. In this role I directly managed and was accountable for the medicine candidate and development budget, and I served as the steward for new medicine development plans at milestone / decision-point at internal governance meetings.

Leverkusen, North Rhine-Westphalia, De

Responsible for managing a team of 6 US & European-based regulatory professionals focused on the global regulatory strategy for a portfolio of Bayer's oncology drugs. The global oncology porfolio I managed included the marketed drugs Aliqopa (copanlisib), Stivarga (regorafenib), and Nexavar (sorafenib), as well as multiple oncology compounds currently in early development.I have also led multiple special projects within Bayer, including a multi-company FDA Advisory Committee meeting focused on Antimicrobials & Drug Safety / Risk Management, and multiple Global Meetings of 60 - 120 attendees.

Leverkusen, North Rhine-Westphalia, De

Responsible for managing a team of 6 US & European-based regulatory professionals focused on the global regulatory strategy for a portfolio of Bayer's oncology drugs. The global oncology porfolio I managed included the marketed drugs Nexavar and Stivarga, the Pi3K inhibitor Copanlisib, as well as multiple oncology compounds currently in early development.I have also led multiple special projects within Bayer, including a multi-company FDA Advisory Committee meeting focused on Antimicrobials & Drug Safety / Risk Management, and multiple Global Meetings of 60 - 120 attendees.

Leverkusen, North Rhine-Westphalia, De

Managed team of 55 regulatory professionals including direct line management of 12 Asia-Pacific Country Heads plus 3 Regional Regulatory Strategists. Responsible for Bayer’s development and market portfolio in Asia-Pacific to obtain health authority approvals with competitive labeling while maintaining optimal regulatory compliance.Ensured alignment of regulatory staff in the Asia Pacific region strategically and operationally to support the regional business objectives and accountable for interactions with national regulatory authorities through the local regulatory representatives. Represented Asia-Pacific region to Global Regulatory Affairs Management Team and provided budgetary oversight to meet financial targets.

Leverkusen, North Rhine-Westphalia, De

Led multidisciplinary team in preparing and filing multiple New Molecular Entity NDAs, obtaining 1st cycle NDA approvals. Led all interactions between Bayer and FDA, including labeling negotiations and responses to clinical and pre-clinical questions. Led meetings with FDA for lifecycle development opportunities.Led 30-member team and coordinated with 3 external vendors to prepare for FDA Advisory Committee; received unanimous vote for approval. Led team in developing Bayer Advisory Committee Best Practices guidance. Recognized with Bayer Leadership award for work on NDAs.

Switzerland 🇨🇭 , Ch

Switzerland 🇨🇭 , Ch

Switzerland 🇨🇭 , Ch

Master Of Business Administration - Mba, Management Of Science And Innovation

Raps Executive Development Program, Regulatory Management

Bachelor Of Science - Bs, Chemistry