Senior Vice President, Technical Operations

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. With a strong scientific foundation and a founding team that includes the discoverer of our target pathway, we are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones. We are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning.

We are seeking an experienced Senior Vice President, Technical Operations to lead all CMC activities across our portfolio. This role will provide the vision, leadership, strategy and management skills to oversee, lead and further expand the CMC development and manufacturing of the company’s proprietary programs through preclinical, clinical and commercial stages.  This individual will collaborate with other senior leaders in the organization to ensure CMC execution is tightly aligned with research, clinical, regulatory, commercial and corporate objectives.

The Senior Vice President, Technical Operations is responsible for translating the corporate strategy into global pharmaceutical development and manufacturing strategies (functional areas include chemical development, product development, analytical development, quality control, manufacturing, clinical supply and CMC program management). The SVP will provide technical leadership, strategic direction, risk assessment, and oversight for successful long-range planning and execution across all supporting functions. This individual will manage Contract Development and Manufacturing Organizations (CDMOs) including implementation of strategy, selection, onboarding and relationship management.

As a key member of the leadership team, you will interface regularly with executive leadership and the Board, translating complex technical, operational and regulatory topics into clear, concise, and actionable insights that support rapid and informed decision-making. The ideal candidate will be a seasoned pharma/biotech executive with an outstanding record of accomplishment in development and manufacturing of pharmaceuticals with experience in the global submissions and commercialization.  This is an exciting opportunity to shape CMC strategy end-to-end and build a world-class CMC organization in a growing, science-driven organization.

Reports to: Chief Scientific Officer
Location: Remote (U.S.)

Responsibilities:

CMC Strategy & Leadership

• 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.

Development, Manufacturing & Supply

• Ensure reliable preclinical, clinical and future commercial supply of safe, high-quality drug products and lead development of manufacturing strategies to ensure capacity for the product portfolio. 
• 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 that supports Phase 1 through Phase 3 and commercial readiness
• Oversee clinical supply planning, forecasting, and distribution in collaboration with external manufacturers and logistics partners

Regulatory & Compliance

• 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

Executive & Board Communication

• 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

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, with 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, preferably with 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, regulatory requirements, and small-molecule drug development
• Demonstrated ability to work independently, think strategically, and 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

Compensation Range: $315,000 - $390,000 (actual compensation may vary based on experience, qualifications and location)

Working at Faeth

Benefits:

• Competitive salary and equity in a well-funded, clinical-stage biotech
• 100% remote work and flexible schedule
• Health, dental, and vision for you and your dependents
• Flexible time off
• Generous parental leave
• Traditional and Roth 401k 
• Mission oriented, remote first culture

We are an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

All offers of employment are contingent upon satisfactory completion of a background check and verification of eligibility to work in the United States.