Company Overview

Cambrian Bio (Cambrian) is a clinical-stage drug development company focused on building therapeutics to treat and ultimately prevent some of today’s most debilitating chronic diseases. Each program at Cambrian is led by its own R&D team in collaboration with experts dedicated to a pipeline company. This model allows Cambrian to develop new drugs efficiently, partner flexibly across the healthcare ecosystem, and reward the scientists whose vision drives the creation of new medicines.

Amplifier Therapeutics, is a Sweden-based biopharmaceutical pipeline company within Cambrian. It is focused on developing AMP-activated protein kinase (AMPK) activator compounds to treat diseases associated with aging, including metabolic conditions, cardiovascular disease, kidney disease, and cancer. Its lead asset, ATX-304, is currently in human clinical trials.

Position Overview

Cambrian is seeking a Senior Director Pharmaceutical Development to lead Chemistry, Manufacturing, and Control (CMC) activities with an emphasis on formulation and late-stage drug product development particularly in the small molecule space. The successful candidate will ensure end-to-end clinical and commercial supply planning and oversee key partnerships with vendors and Contract Custom Development and Manufacturing Organization (CCDMOs) for our lead program, ATX-304.

Reporting to the Chief Medical Officer, the Senior Director of Pharmaceutical Development will be instrumental in driving drug product development with emphasis on formulation development and late-stage clinical phases through commercialization. The Senior Director will be tasked with leading at a strategic level while remaining hands-on with key operational activities, ensuring seamless execution across both tactical and leadership functions. This role blends strategic and operational responsibilities, encompassing areas such as formulation and process development, technology transfer, and regulatory compliance

Responsibilities

• Drug Product formulation development and development of analytical methods that are appropriate for each development stage, aligning with intended use and regulatory expectations for late stage clinical
• Collaborate cross-functionally on process development, analytical testing, manufacturing, and continuous improvements to meet milestones
• Vendor selection and oversee the development, manufacturing, and supply chain operations for ATX-304, ensuring timely clinical and commercial supply, including import/export compliance and alignment with local requirements. Lead trial supply planning, technology transfer, and formulation development to support successful scale-up and commercialization.
• Forge strong relationships with CMOs, CROs, and suppliers to optimize operational efficiency, productivity, quality and supply assurance. Provide technical oversight for process optimization, cGMP manufacturing, and supply of Drug Substance (DS) and Drug Product (DP) from clinical phases through commercialization.
• Establish and maintain robust interfaces with regulatory agencies (e.g., FDA, EMA) and notified bodies, assuming accountability for CMC sections of regulatory submissions such as INDs, BLAs, NDAs, and MAAs. Ensure alignment with internal and external stakeholder requirements, focusing on process optimization, quality standards, and budgetary control.
• Collaborate with cross-functional teams to establish the supply network, negotiate with vendors, and manage day-to-day vendor operations to ensure consistent product supply.
• Develop and implement comprehensive CMC strategies, encompassing program plans, budgets, timelines, and risk mitigation for clinical and commercial programs.
• Monitor and manage key performance metrics, including production cost, quality benchmarks, and accurate budgeting and forecasting. Maintain quality systems and cGMP compliance, driving continuous product and process improvements.

Requirements

• Master’s degree or Ph.D. in chemical engineering, chemistry, organic chemistry, or a related scientific discipline.
• 12+ years of experience in the pharmaceutical or biotech industry, with extensive experience in drug product development, technical operations, and CMC activities, including late-stage clinical programs.
• Extensive knowledge of drug development strategies, cGMP regulations, formulations, differentiated drug delivery products, and multiple drug modalities, small molecules is a must.
• Proven experience in drug formulation, process optimization, analytical development, technology transfer, and clinical supply chain management.
• Deep understanding of CMC issues and their impact on successful regulatory submissions (INDs, NDAs, BLAs, MAAs).
• Strong experience working with global regulatory agencies (e.g., FDA, EMA) and managing international supply chains.
• Proven experience working in small or emerging biotech companies, demonstrating the ability to thrive in resource-constrained environments with shifting priorities, and direct involvement in hands-on operations, decision-making, and cross-functional collaboration.
• Demonstrated ability to build and lead high-performing cross-functional CMC teams across multiple sites and disciplines.
• Strong leadership presence as a subject matter expert, driving continuous improvement and tackling complex challenges with minimal supervision.
• Proven skills in influencing, managing, and fostering collaboration within global organizations and across external vendors.
• Proficiency in budget management, forecasting, and navigating complex CMC challenges.
• Exceptional written and verbal communication skills, with proficiency in relevant software tools and systems.
• Strong organizational abilities, with a proven aptitude for multitasking in high-growth, fast-paced environments.
• Thrive in a dynamic, collaborative environment, working effectively both independently and with cross-functional teams.

Cambrian Offers

Compensation

Cambrian offers competitive compensation packages that are made up of base salary, bonus and equity:

• Salary: $200,000 - $250,000 offered to NYC employees, commensurate with relevant experience; salary range may vary depending on state of residence
• Bonus: up to 15% based on performance
• Equity: Employee stock options vesting over 4 years with 1-yearcliff

Benefits

In addition to being part of a brilliant team of collaborative innovators, you will also enjoy the following benefits as a member of the Cambrian team:

• 16 Company holidays and unlimited vacation policy
• Comprehensive medical, dental, and vision insurance with fully employer paid coverage options for employees
• 401K with pre-tax and Roth contribution options
• Employee Assistance Program to provide free, confidential support for all employees and their dependents through Optum’s Life and Work Well
• Flexible spending accounts and health savings account
• Adoption assistance
• Short & long term disability
• Basic life & AD&D insurance, as well as voluntary life insurance

Cambrian Biopharma is proud to be an equal employment opportunity and affirmative action employer. We celebrate diversity and do not discriminate based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.