The role:

The Vice President of Biometrics will provide strategic and operational leadership across statistical activities as the company transitions into Phase III clinical trials. This role will be responsible for defining and executing the integrated biometrics strategy, overseeing CRO and vendor partnerships, ensuring data integrity and regulatory readiness, and serving as a key leader on the clinical development team. The ideal candidate brings deep late-stage expertise, strong cross-functional leadership, and a hands-on mindset well suited for a lean, fast-growing biotech organization.

Key responsibilities:

• Provide strategic leadership for biometrics across all clinical development programs, with primary focus on Phase III execution
• Define and implement an integrated biometrics strategy supporting clinical trial design, data quality, statistical analysis, and regulatory submissions
• Serve as a core member of the clinical leadership team, partnering closely with Clinical Operations, Data Management, Regulatory Affairs, Safety, and Medical Affairs
• Lead and oversee CROs and external vendors responsible for biostatistics statistical programming and related biometrics activities.
• Oversee development and review of key deliverables including SAPs, DMPs, CRFs, TFL shells, interim analyses, database locks, and clinical study reports
• Ensure data integrity, statistical rigor, and compliance with GCP, ICH, and global regulatory requirements
• Provide strategic input into study design, endpoint selection, sample size calculations, and adaptive or innovative trial methodologies as appropriate
• Support regulatory interactions and submissions, including briefing documents, responses to health authority questions, and advisory committee preparations
• Establish scalable biometrics processes, standards, and SOPs to support late-stage development and future pipeline growth
• Build, mentor, and lead internal biostatistics capabilities over time, as appropriate to company growth

Required experience & skills:

• Bachelor’s degree or advanced degree, ideally in biostatistics, statistics, mathematics, or a related quantitative discipline
• Minimum of 12 years of progressive experience in biostatistics within the biotechnology or pharmaceutical industry
• Significant experience leading biostatistics activities for Phase III clinical trials and regulatory submissions
• Demonstrated success managing CROs and external vendors in a late-stage development environment
• Proven track record as a strategic biometrics leader, contributing substantively to complex study designs, endpoint development, and statistical strategy across global development programs; able to provide sharp, on-your-feet thinking in real-time discussions with regulators, KOLs, and cross-functional teams, while maintaining a roll-up-your-sleeves approach to engage directly with protocols, analysis plans, and data when needed.
• Strong understanding of global regulatory expectations related to clinical data, statistical analyses, and inspection readiness
• Proven ability to operate strategically while remaining hands-on in a lean organization
• 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:

• Prior experience serving as a functional or biometrics lead in regulatory interactions with FDA and ex-U.S. health authorities
• Experience in cardiovascular, rare disease, or genetically driven conditions
• Background in small or mid-sized biotech companies transitioning into late-stage development
• Experience building or scaling internal biometrics functions and infrastructure
• Familiarity with innovative trial designs and modern statistical methodologies

Base Salary Range: $300K - $375K

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:

The Clinical Trial Management Associate (CTMA) is a key member of the Clinical Operations team and will partner closely with the Clinical Trial Manager (CTM), Senior CTM, and Associate Director, Clinical Operations. The CTMA will support the execution of a global Phase 3 program, with a primary focus on study coordination, documentation, and operational support. Under the supervision of the Associate Director, Clinical Operations or the Senior CTM, the CTMA may manage sites within a region (e.g., EMEA or Americas) and/or vendors (e.g., IRT, eCOA, etc.)

Key responsibilities:

• Provide operational and administrative support for day-to-day clinical trial activities, including study start-up, maintenance, and close-out.
• Support site start-up activities, including tracking of site start-up components and assisting with site activation readiness.
• Accountable for study level tracking at Sponsor (e.g., monitoring visit tracking, sample tracking, patient tracking, site activation tracking, etc.)
• Act as a point of contact for CROs and study sites for routine communications and follow-ups, including escalations and engagement. Assist with coordination of investigator meetings and study-related communications.
• Track study timelines, deliverables, and key milestones; proactively follow up on outstanding items.
• Maintain internal Clinical Operations systems, trackers, and document repositories. Prepare and distribute study status updates and meeting minutes and ensure vendors do the same.
• Assist with vendor coordination and oversight, including vendor set-up, performance, and deliverable tracking. May assist with administration of invoice reconciliation, scoping, and change orders, for clinical trial operations.
• Support review of study documents (e.g., informed consent forms, regulatory packages) and route for approval.
• Maintain and QC the Trial Master File (TMF) and ensure documents are filed in a timely and compliant manner; create, maintain, and close out TMFs; play a central role in setup, conduct, and close out of ancillary services; facilitate quality reviews and support trending activities.
• Facilitate and/or assist in review of CRO monitoring trip reports for completeness and consistency and, under supervision of other Operations personnel, may complete co-monitoring activities.
• Track protocol deviations and support trending activities.
• Support data review activities, including tracking queries and assisting with data listings review.
• Perform administrative duties in a timely manner as assigned.
• Adhere to Clinical Operations processes and SOPs.

Required experience & skills:

• BS or BA in a relevant scientific discipline or RN (2- or 3-year certificate)
• Minimum of 2 years of relevant clinical trial experience
• Clinical trial experience in the pharmaceutical or biotechnology industry 
• Excellent attention-to-detail, interpersonal and presentation skills are a critical asset
• Excellent organizational, problem-solving and time management skills
• Must be familiar with routine medical/scientific terminology
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
• Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus)
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• High energy level, personal productivity, creativity and commitment
• Highly adaptable team-player; eager to learn
• 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
• This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable

Salary Range: $100,000 - $135,000

The role:

The Senior Clinical Trial Manager (Sr. CTM) is a key leader within the Clinical Operations team and will report to the Senior Director, Clinical Operations. The Sr. CTM will be responsible for the end-to-end operational delivery of a study in collaboration with other study leads across the program. This includes providing strategic oversight of study execution, vendor management, financial accountability, and cross-functional alignment.

Key responsibilities:

• Serve as the study lead for one or more global clinical trials, overseeing day-to-day execution from start-up through close-out (including site activation, enrollment, study conduct, and close-out) under the guidance of the Senior Director, Clinical Operations.
• Partner closely with the Clinical Operations study leads on key decisions by providing recommendations, proactively identifying risks, and escalating critical issues with proposed mitigation strategies.
• Drive study timelines, deliverables, and operational plans, ensuring alignment with overall program strategy. Monitor study metrics, including data quality, protocol deviations, and site performance, and drive appropriate follow-up actions.
• Oversee and support regional study execution, including site selection strategy, site start-up, and study progress; ensure efficient and timely study start-up across regions. Oversee and participate in the review of informed consent forms and regulatory submission packages.
• Perform visits (PSSVs, SIVs, RMVs) as required to demonstrate appropriate oversight of CRO CRAs and study sites to ensure study procedure conduct is in accordance with the study protocol, SOPs, regulatory requirements, and study plans.
• Oversee CRO and vendor activities, ensuring performance aligns with study expectations, timelines, budget, and quality standards. Support budget tracking and vendor financial oversight.
• Support cross-functional coordination across Clinical, Regulatory, Data Management, Safety, and other stakeholders to ensure aligned study execution.
• Contribute to, or own the development of, key study documents (e.g., protocols, ICFs, CRFs, monitoring plans, CSRs); under the guidance of the Senior Director, Clinical Operations (or designee) develop operational documents such as vendor specifications, study plans, SIV materials, Investigator Meeting content, and protocol amendments.
• Ensure inspection readiness and compliance with GCP, SOPs, and regulatory requirements, including timely TMF filing.
• Participate in study reviews, including data listings, protocol deviation review, TMF quality, and monitoring visit reports; identify trends and drive appropriate follow-up actions.
• Provide regular, structured study updates to internal stakeholders as directed by the Senior Director, Clinical Operations.
• Mentor and provide day-to-day guidance to CTMs, CTMAs, and other junior team members that may be providing study support or regional management.
• Perform administrative duties in a timely manner as assigned.
• Contribute to Clinical Operations process improvements and departmental initiatives, as requested by the Senior Director, Clinical Operations.

Required experience & skills:

• BS or BA in a scientific discipline or an RN (2- or 3-year certificate)
• At least 6 years of clinical trials/operations experience in the pharmaceutical or biotechnology industry
• Proven ability to manage complex, cross-functional projects and timelines
• Experience as a regional lead (e.g., Europe, Americas, and/or APAC) on a Phase 3 (or large Phase 2) study required; study lead experience preferred
• Strong experience with CRO and vendor management, including oversight of performance and deliverables
• Excellent leadership, communication, and stakeholder management skills
• Strong organizational and time management skills
• Strong problem-solving skills, with the ability to anticipate risks and implement mitigation strategies
• Excellent attention-to-detail, interpersonal and presentation skills are a critical asset; high energy level, personal productivity, creativity and commitment
• Proven track record of mentoring and developing junior team members through coaching and knowledge-sharing; direct people management experience is a plus
• Strong written and verbal communication skills with a collaborative, team-oriented approach.
• Must be familiar with routine medical/scientific terminology
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency is a plus)
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• 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
• This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable

Salary Range: $160K to $185K

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

The role:

The Clinical Trial Manager (CTM) is a key member of the Clinical Operations team and will report into the Associate Director, Clinical Operations, partnering closely on the start-up and initiation of a global Phase 3 program. The primary responsibility of the CTM will be regional study management and vendor management.

Key responsibilities:

• With guidance from the Associate Director, ClinOps, responsibility for day-to-day activities within a region or regions, including site selection, start-up, maintenance, and close-out activities. With guidance, may serve as the key operational contact for Braveheart Bio studies aiding in site selection, study implementation, and ongoing coordination of study sites, either directly or via CROs.
• Assist Associate Director, ClinOps with oversight of CRO and set-up of vendors as required, including liaising with Global CRO to ensure timely initiation of study.
• Day-to-day contact with counterparts at CRO and/or trial sites, including daily review and identification of potential issues or problems that must be communicated/escalated directly to Associate Director, ClinOps.
• Review site Informed Consent Forms and escalate to appropriate individuals, as needed. Assist with regulatory submission package review for submissions within region.
• Proactively identify potential operational challenges and, in collaboration with senior team members, provide solutions to ensure study execution remains on track.
• Perform accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure study procedure conduct is in accordance with SOPs and protocol procedures, and review routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• With guidance, may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochure appendices under close supervision.
• Review of trip reports generated by CRO CRAs for trends and quality issues.
• Review protocol deviations and monitor for trends.
• Coordinate review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies.
• Provide regular study updates to the appropriate internal stakeholders.
• Maintain internal Clinical Operations databases and document repositories.
• Perform administrative duties in a timely manner as assigned.
• Guide and support junior team members, ensuring alignment on deliverables, timelines, and quality standards.

Required experience & skills:

• At least 4+ years of relevant experience with a BS or BA in a relevant scientific discipline or an RN (2- or 3-year certificate)
• Relevant clinical trial experience in the pharmaceutical or biotechnology industry 
• Experience as the regional lead for Europe, United States, Latin America, and/or APAC
• Excellent attention to detail, interpersonal and presentation skills are a critical asset
• Excellent organizational, problem-solving and time management skills
• Must be familiar with routine medical/scientific terminology
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
• Must be familiar with Word, PowerPoint, and Excel (intermediate or higher excel proficiency a plus)
• Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
• High energy level, personal productivity, creativity and commitment
• Highly adaptable team-player
• 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
• This position is for remote work and may require domestic or international travel up to 25% (as needed); valid travel documents must be obtainable.

Salary Range: $140,000 - $170,000

The role:

As we advance our myosin inhibitor into Phase 3 clinical development for Hypertrophic Cardiomyopathy (HCM), our Medical Director will serve as a key clinical leader, responsible for shaping and executing the company’s late-stage clinical strategy and ensuring scientific and regulatory excellence through this  phase of development.  Reporting to our CMO, the (Senior) Medical Director will bring their expertise in Cardiology, ideally with HCM, as well as Phase 3 design and execution.  This individual will employ strategic leadership, operational agility, and cross-functional collaboration across Clinical Operations, Regulatory Affairs, Biometrics and other development functions to ensure successful global trial delivery and regulatory readiness.

Key responsibilities:

• Lead the clinical strategy and execution for the HCM program, including Phase 3 trial design, implementation, and oversight.
• Serve as Medical Monitor for assigned clinical studies, ensuring patient safety, data integrity, and protocol adherence across all global sites.
• Provide medical and scientific leadership to cross-functional study teams, including Clinical Operations, Regulatory, Biostatistics, and Data Management.
• Partner with Regulatory Affairs to support global health authority interactions, including IND/CTA submissions, briefing documents, and responses to regulatory inquiries.
• Collaborate with the Chief Medical Officer and senior leadership to define and execute the overall clinical development plan and ensure alignment with corporate strategy.
• Lead clinical data interpretation, analysis review, and support preparation of clinical study reports, manuscripts, and scientific presentations.
• Engage with external experts, investigators, and key opinion leaders (KOLs) to inform program strategy and strengthen Braveheart Bio’s scientific network in cardiology and HCM.
• Contribute to development of risk mitigation strategies, protocol amendments, and study governance processes.
• Support internal decision boards and cross-functional portfolio planning as the clinical subject matter expert for the HCM program.

Required experience & skills:

• M.D. or D.O. degree (board certification in cardiology or related specialty preferred)
• Minimum of 6 years of clinical development experience in the biopharmaceutical industry, including leadership of Phase 3 trials
• Proven track record of clinical trial design, implementation, and medical oversight within cardiology or a closely related therapeutic area
• Experience interfacing with global regulatory authorities and contributing to pivotal submission packages
• Demonstrated ability to synthesize complex clinical and scientific data and communicate clearly to internal and external stakeholders
• 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:

• Experience specifically in Hypertrophic Cardiomyopathy (HCM) or broader cardiomyopathy/cardiovascular disorders is strongly preferred
• Prior experience as a Global Clinical Lead or equivalent senior role overseeing multicenter, global late-stage programs
• Demonstrated success fostering cross-functional collaborations and managing external partnerships or CROs
• Knowledge of biomarkers, imaging endpoints, and patient-reported outcomes relevant to cardiovascular diseases
• Strong familiarity with regulatory frameworks for pivotal trials (FDA, EMA, PMDA) and BLA/NDA/MAA filings
• Strategic thinker with the ability to balance scientific rigor and pragmatic execution in a startup setting

Base Salary Range: $269,000 - $385,000