Senior Vice President, Technical Operations

New

Faeth TherapeuticsOncology

Remote (U.S.)Full-TimeExecutive

Salary315000 - 390000 USD per year

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Job Details

Experience: 15+ years

Requirements

PhD in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline (strongly preferred); Bachelor’s or Master’s with significant relevant experience considered
15+ years of progressive CMC experience in pharmaceutical development and manufacturing
Demonstrated senior-level ownership of CMC programs with significant small molecule experience
Strong record of accomplishments and successful leadership experience leading and executing CMC development and commercial manufacturing
Experience in an emerging pharmaceutical company that has scaled from early-stage product development to commercial operations
Demonstrated ability to build a successful technical and operations organizations
Deep understanding of GMP
Deep understanding of regulatory requirements
Deep understanding of small-molecule drug development
Demonstrated ability to work independently
Demonstrated ability to think strategically
Demonstrated ability to solve problems proactively in fast-moving environments
Strong conflict-resolution and problem-solving skills working with diverse organizations and cultures
Exceptional communication skills, with the ability to distill complex issues into clear, decision-ready messages for senior leadership and boards

Responsibilities

Own and drive the end-to-end CMC strategy across development, clinical supply, scale-up, and commercialization for a portfolio of small-molecule programs
Operate with a high degree of independence and accountability, proactively identifying risks, tradeoffs, and opportunities across the CMC landscape
Anticipate CMC challenges well in advance and lead structured problem-solving efforts, balancing speed, quality, cost, and regulatory expectations
Build scalable CMC roadmaps aligned with clinical milestones, financing events, and long-term corporate strategy
Define CMC organizational requirements and ensure corporate objectives are delivered through internal and external resources
Select, manage, and hold CROs, CDMOs, and consultants accountable for performance, quality, and timelines
Develop and manage CMC budget
Support business development and evaluation of in licensing opportunities
Ensure reliable preclinical, clinical and future commercial supply of safe, high-quality drug products and lead development of manufacturing strategies
Provide senior technical oversight of process development, manufacturing, analytical development, and control strategies
Work collaboratively with Quality and Regulatory to ensure robust, phase-appropriate CMC execution
Oversee clinical supply planning, forecasting, and distribution
Oversee global CMC regulatory strategy, ensuring alignment with FDA, EMA, and other regulatory authorities
Oversee preparation, review, and approval of all CMC-related sections of INDs, NDAs, amendments, and variations
Oversee CMC related regulatory interactions, inspections, and agency meetings
Ensure ongoing compliance with GMP and evolving regulatory expectations
Communicate CMC strategy, risks, and decision points clearly to the executive team and Board of Directors
Synthesize complex technical, regulatory, and operational topics into concise, executive-level summaries and visuals
Provide leadership with clear options, implications, and recommendations to support strategic and financial decisions
Act as a trusted advisor on CMC-related matters impacting valuation, timelines, and investor discussions

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