The role:

The Associate Director/Director, Clinical Supplies Management will lead Braveheart’s efforts to produce and distribute packaged drug product to clinical trial sites, and establish the procedures for label-pack and distribution activities for eventual commercialization of Braveheart products. Reporting into the SVP, Development Operations, you will be responsible for inter-site shipping logistics for drug substances and drug products, ancillary materials, intermediates and samples between external partners, including materials for non-clinical studies, clinical trials, and analytical testing. As a member of Braveheart’s CMC (Technical Operations) team, the successful candidate will interface with a diverse team representing Manufacturing and Quality; Program Management, Clinical Development, Clinical Operations, Finance and external partners to support key tasks related to planning, shipping & logistics, labeling, packaging and distribution of investigational materials.  

Key responsibilities:

• Ensure alignment of key activities & timelines of cross-functional team to successfully set up and supply each clinical trial, including maintaining oversight on performance and issues to ensure study supplies are provided in line with the agreed scope of work and timelines. 
• Establish shipping lanes and logistics processes for new clinical trials or new clinical sites including preparation of shipping, importation and exportation documents. 
• Coordinate the resolution of sample and product shipment delays and deviations with vendors, internal teams and partners. Proactively identify potential shipment delays and escalate as needed. Perform root cause analysis of shipping issues in order to identify process improvements. 
• Serve as the single point of contact for key stakeholders for logistics topics. 
• Provide a responsive, effective and successful high level of customer service to Clinical Operations, CMC and Nonclinical partners. 
• Participate in cross-functional distribution-related projects and process improvement initiatives. 
• Enhance delivery of Braveheart’s CMC objectives by fostering strong CDMO/CRO relationships.  
• Use appropriate project management tools to plan and track project deliverables. 
• Participate in CMC Team meetings and provide logistics and supply updates to the Vice President of Manufacturing and CMC and SVP of Development Operations.  
• Facilitate tracking of the movement of drug, intermediates and samples for analytical testing between external partners. 
• Analyze shipping temperature monitoring data and participate/lead investigations for excursions, in close collaboration with Quality. 
• Interface between CMC and Clinical Operations to ensure planning, coordination and communication to enable timely supply of materials. 
• Assist with CMC project budget planning and tracking, including invoice payments, accruals and reforecasting as needed. 
• Assist with circulating RFPs, establishing contracts, amending and approving work programs.  

Required experience & skills:

• Bachelor’s degree in a scientific discipline or business management 
• At least 7 years of experience in logistics and/or supply chain discipline in the Biotechnology/Pharmaceutical industry; supply chain certification is a plus (e.g. APICS, CPIM, CSCP) 
• Extensive experience in Global Import/Export logistics within the biotech/pharmaceutical industry
• Experience in the exportation and importation of human biologic samples and investigational drugs, specific experience in China preferred 
• Proven ability to collaborate effectively on cross-functional teams, both locally and globally, building strong relationships and leading with sophistication across cultures 
• Ability to influence without direct authority and communicate effectively with management, peers, customers, and vendors 
• Strong organizational skills with the ability to prioritize, manage competing priorities, and work independently with high accountability 
• Excellent problem-solving skills, with the ability to anticipate issues and recommend and implement solutions 
• Agile learner who can move effectively between detailed execution and broader project strategy 
• Experience with project integration, planning, documentation, and use of planning tools (Microsoft Project, Excel, PowerPoint and Outlook) 
• Ability to work flexible hours to support global requirements 
• Strong written and verbal communication skills with a collaborative, team-oriented approach 
• Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity 
• Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude 

Preferred experience & skills:

• Direct experience managing global clinical trial supplies 
• Experience managing projects with remote teams and through external alliances 

Salary Range: $174 - $233K

The role:

As Braveheart Bio advances its lead small molecule program toward late-stage development, the Head of CMC will serve as a key technical and operational leader, responsible for all Chemistry, Manufacturing, and Controls (CMC) activities across development and supply.

Reporting to the executive team, this individual will lead drug substance and drug product process development, manufacturing strategy, and external supply chain execution, while partnering closely with internal cross-functional teams and a network of global CDMOs and CROs. The Head of CMC will play a critical role in ensuring regulatory readiness, technical excellence, and scalable, compliant manufacturing to support clinical development and eventual commercialization. A central focus of the role will be driving commercial readiness and supporting a successful global launch, including process validation, scale-up to commercial volumes, qualification of a robust commercial supply network, and delivery of the launch CMC package to support NDA/MAA approval and market entry.

Key responsibilities:

• Direct all aspects (DS/DP) of process development and supply chain operational activities for the company’s programs; work closely with external CROs/CDMOs, collaborators, and/or partners to rapidly advance programs to key decision points.
• Develop and direct strategies for upstream and downstream process development, analytical development, and formulation development (including management of associated external CDMOs/CROs).
• Author and review technical sections for company’s global regulatory submissions (INDs, CTAs, IMPDs, NDAs, MAAs, meeting requests, briefing documents, responses to health authority questions, etc.) related to assigned programs.
• Collaborate with team members to efficiently evaluate, select, and manage contract service providers (CDMOs and CROs), including technology transfer, process scale-up, design of validation strategies, packaging development, and technical expertise with regards to routine/non-routine development and cGMP activities (e.g., deviations/investigations, process improvements, change controls, CAPAs, etc.).
• Lead end-to-end commercial CMC readiness, including process performance qualification (PPQ), process validation, analytical method validation, and stability programs required to support NDA/MAA filings and global launch.
• Build and qualify the commercial supply network, including launch and post-launch demand planning, inspection readiness for pre-approval inspections (PAI), serialization and packaging strategy, and partnership with Commercial, Quality, and Regulatory to ensure on-time product availability across launch markets.
• Oversee the development and maintenance of the budget for assigned program activities, including the preparation of cost estimates for new work.
• Develop and/or provide technical review of development documents (batch records, experimental data, protocols, reports, analytical methods, SOPs, etc.).
• Play a leadership role in the creation, maintenance, improvement, and compliance with quality system.
• Contribute to the generation and protection of company intellectual property.
• Lead, develop, and mentor direct reports.
• Demonstrate success in a dynamic, interactive, fast-paced, and entrepreneurial environment.

Required experience & skills:

• Ph.D. (or equivalent) in Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or a closely related field; exceptionally strong master’s candidates will be considered
• Fifteen-plus years’ experience in the pharmaceutical or biotech industry, with five-plus years’ demonstrated leadership in small molecule process development
• Experience with global pharmaceutical/biotech development and manufacturing operations for development-stage small molecule assets, including upstream/downstream process development, formulation development, analytical development, and device development
• Leadership experience in managing diverse project activities with contract CDMO facilities
• Direct experience with successful registrations and commercial launch of novel assets
• Hands-on experience leading commercial readiness activities, including PPQ, process and analytical method validation, pre-approval inspection (PAI) readiness, and qualification of commercial-scale supply for global launch
• Experience with clinical supply management, process scale-up and technology transfer, cGMPs, and ICH guidelines, as well as the CMC content of global regulatory submissions
• Experience with small molecule development programs, from early stage through commercial
• Knowledge of cGMP regulations
• Hands-on, roll-up-your-sleeves approach, with high sense of urgency and drive for results
• Demonstrated communication, problem-solving, and negotiation/decision-making skills
• Ability to think outside of the box and challenge the status quo
• Natural entrepreneurial spirit with unrelenting dedication to delivering results
• Desire to work in a fast-paced, innovative environment
• Natural collaborator who enjoys working on a cross-functional team
• Ability to travel 10-20%, domestic and/or international

Base Salary Range: $300K - $375K