Senior Director, CMC Leader for Cardiovascular and Metabolism Biotech

Join to apply for the Senior Director, CMC Leader for Cardiovascular and Metabolism Biotech role at Clora

Senior Director, CMC Leader for Cardiovascular and Metabolism Biotech

Join to apply for the Senior Director, CMC Leader for Cardiovascular and Metabolism Biotech role at Clora

This range is provided by Clora. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$200,000.00/yr - $250,000.00/yr

Logistics

Remote, ideally from EST & CST time zones, or EU-based

Travel Requirements: N/A

Annual base salary range: $200,000 - $250,000

About

Clora's client is a clinical-stage biotechnology company focused on treating and preventing chronic diseases of aging. They are looking for a seasoned CMC consultant with an emphasis on formulation/reformulation and late-stage drug product development particularly in small molecule space. The successful candidate will ensure end-to-end clinical and commercial supply planning and oversee key partnerships with vendors and CDMOs with a strong focus on our lead program. Reporting to the Chief Medical Officer, the Senior Director of Pharmaceutical Development will be instrumental in driving drug product development with emphasis on 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 the lead program, 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.

Ideal Candidate

• 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, reformulation, 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.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

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