Corsera Health is seeking a Clinical Trial Associate to support the operational execution of our clinical programs. You will work closely with the Clinical Operations team to coordinate study activities, manage essential documents, and support site communications across the trial lifecycle.

This role is ideal for a detail-oriented early-career professional who thrives in fast-paced, collaborative environments and wants to contribute to the development of novel cardiovascular therapeutics.

Key Responsibilities:

You will be responsible for:

Trial Operations Support

• Support day-to-day operational activities for assigned clinical studies.
• Assist in the preparation, tracking, and maintenance of essential study documents (Trial Master File).
• Help coordinate meetings, agendas, and minutes with internal teams, CROs, and investigator sites.
• Track study timelines and deliverables; flag risks or delays to the study lead.

Site & Vendor Coordination

• Support site activation activities including document collection and regulatory submissions.
• Assist with CRO and vendor oversight by tracking deliverables and escalating issues as needed.
• Coordinate clinical supply shipments and inventory tracking with vendors and sites.

Qualifications:

• Bachelor’s degree in life sciences, nursing, or a related field.
• 1–3 years of experience in clinical operations or a related clinical research role.
• Working knowledge of ICH-GCP and applicable regulatory requirements.
• Strong organizational skills and attention to detail.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team in a fast-paced environment.

Bonus points if you have:

• Prior experience at a biotech or pharmaceutical sponsor.
• Experience working with electronic Trial Master File (eTMF) systems.
• Exposure to cardiovascular or metabolic disease clinical programs.

We are seeking a highly motivated and strategic Director, Quality Assurance to build a culture focused on quality at Corsera. This leader would also build and implement a fit-for-purpose GxP Quality Management System at the company. This role is pivotal in providing quality oversight of our external vendors, Contract Development and Manufacturing Organizations (CDMOs) and service providers.

The ideal candidate combines deep technical expertise in building quality management systems, providing vendor oversight, managing & proactively mitigating quality & compliance risks and applying extensive knowledge of cGMPs.

Key Responsibilities:

Reporting to the COO, you will be responsible for:

• Ensuring compliance with applicable Global Regulatory requirements and guidelines across the enterprise by building and implementing a fit-for-purpose GxP Quality Management System.
• Providing quality oversight for GMP manufacturing activities, including review and approval of batch records, deviations, investigations, and change controls to ensure compliance with applicable GxP requirements.
• Providing quality oversight of external vendors, CMOs, and service providers, including quality agreements, issue management, and performance monitoring.
• Applying quality risk–based thinking to identify, assess, and proactively mitigate quality and compliance risks across GMP operations and quality systems.
• Building, implementing, and continually improving risk management & issue management processes across GxP; ensuring a single repository of critical issues are archived and, with the support of the Head of Quality, issues are escalated in a timely manner.
• Centralizing GxP Supplier Quality Management; direct responsibility for operational support for GMP SQM and external auditing.
• Developing functional area goals and contributing to several strategic corporate initiatives; ability to prioritize goals and delegate tasks/projects appropriately.
• Strong working knowledge of QA principles and global regulations and guidelines.
• Ability to work collaboratively in a fast-paced, dynamic work environment, while managing multiple priorities.
• Proficient working knowledge of electronic quality management systems and the available metric/reporting functionality.

Qualifications:

• 12+ years of experience with a bachelor’s degree in a related field; 8+ years of experience with a Master’s in a related field (prefer scientific discipline).
• Direct line management experience with proven track record of developing and managing a team of staff/consultants.
• Extensive knowledge of cGMPs; working knowledge of GLP, GCP, GVP a plus.
• Experience establishing in-house Quality policies, guidelines, SOPs and associated training programs.
• Direct experience in Health Agency inspections.
• Must have excellent attention to detail, time management and investigative skills, as well as the ability to manage multiple priorities with aggressive timelines.
• Clear, concise communication appropriately tailored to a broad audience; measured & diplomatic when presenting risks and issues; increasing proficiency of executive presence.
• Proven track record of seasoned judgement based on industry knowledge, past experiences, and stakeholder feedback when making decisions.
• Independently manages a portfolio of projects/risks with ease while escalating only critical issues to leadership.

Bonus points if you have:

• Demonstrated success in managing complex CDMO partnerships across different geographies.
• Exceptional communication skills and the ability to lead cross-functional teams in a fast-paced environment.
• Experience working in a start-up environment.

Are you a passionate, organized, and results-oriented accounting leader? Do you thrive in fast-paced environments and get energized by the challenge of bringing innovative new therapies to market? Corsera Health aims to lead the future of medicine by extending healthspan through cardiovascular disease prediction and prevention, and we are seeking a Financial Controller to lead our accounting function during this exciting stage of growth.

As our Financial Controller, you will be responsible for overseeing all aspects of accounting, financial reporting, and compliance, while building the systems, processes, and controls to support our next phase of expansion. You will work closely with the CFO and senior leadership, playing a key role in managing all accounting and finance activities while building and operating in a “public company ready” manner with a focus on supporting a potential IPO within the next 18-36 months.

Key Responsibilities:

Accounting Operations & Financial Reporting

• Lead and manage day-to-day accounting operations, including oversight of outsourced accounting firm.
• Streamline and manage the month-end close process, ensuring timely and accurate financial statements.
• Lead and manage quarterly reviews and annual audit, serving as the primary point of contact with external auditors.
• Provide timely reporting to the Board, investment partners and other stakeholders.
• Identify and execute process improvements for efficiency and accuracy in financial operations.
• Oversee tax work, coordinating with external tax advisor.

Controls, Compliance & Risk Management

• Develop, implement, maintain, and update internal controls in accordance with Sarbanes Oxley (SOX) requirements.
• Oversee risk management functions, including insurance programs and compliance monitoring.
• Partner with Human Strategy to ensure accurate, compliant bi-weekly payroll processing.
• Manage equity administration, including stock option and grant activity.

Technical Accounting & Policy

• Perform and implement technical accounting research, prepare accounting memorandums, and ensure adherence to US GAAP.
• Collaborate with Legal on contract and agreement reviews to ensure appropriate accounting treatment and financial terms.
• Establish, monitor, and enforce financial policies and procedures.

Treasury

• Oversee treasury and cash management, including maintaining and reporting cash flow projections.
• Support corporate financing activities, including preparation for potential IPO readiness.

Qualifications:

• Minimum of 8-10 years of progressive experience in accounting and financial roles.
• Prior experience in the biotech industry.
• Strong understanding of US GAAP, Sarbanes Oxley requirements, SEC regulations, and external financial reporting requirements.
• Proven ability to manage complex projects, prioritize tasks, and meet deadlines in a fast-paced environment.
• Excellent communication, interpersonal, and negotiation skills.
• Ability to work independently and as part of a team.
• Strong analytical and problem-solving skills.

Bonus points if you have:

• Experience in taking a company public through an IPO.
• Experience supporting corporate transactions, including financings, acquisitions, and partnerships.

Corsera Health is seeking a Senior Director, Translational Sciences, to provide leadership, operational oversight, and hands-on expertise across pharmacology and translational science activities across nonclinical programs and in support of clinical development programs.

This role is central to ensuring the smooth execution of PK/PD sampling, bioanalytical workflows, data flows, and analyses as programs come online and progress through nonclinical pharmacology, toxicology and into the clinic. The successful candidate will be deeply data-oriented, operationally strong, and comfortable owning PK data from sample collection through final analysis and presentation.

While this individual will contribute to clinical pharmacology strategy and protocol development, the role is primarily focused on execution excellence, data stewardship, and consistency across studies rather than primary study design.

Key Responsibilities:

Nonclinical and Clinical Pharmacology Operations & Data Stewardship

• Serve as the steward of PK, PD, and pharmacology data across nonclinical and clinical studies.
• Ensure PK/PD samples are handled appropriately to quality specifications, from collection through final analysis.
• Perform and oversee non-compartmental PK/TK analyses for human and relevant animal studies.
• Own data digestion, interpretation, visualization, and presentation, including curves, tables, and summary outputs; presentation to senior leaders as required.

Operational & Logistical Support

• Coordinate the PK/PD sample lifecycle, including scheduling, kit deployment, shipping logistics, reconciliation, and data transfers.
• Respond to site queries related to PK sampling and resolve operational issues.
• Implement QC processes to ensure data consistency and readiness for internal review, investor materials, and regulatory submissions.

Vendor & CRO Oversight

• Manage oversight of bioanalytical CROs, PK data vendors, and DMPK partners.
• Track timelines, deliverables, assay performance, and deviations.
• Coordinate vendors performing DMPK analyses, ensuring compliance with quality and timelines.
• Review and interpret DMPK study results to inform clinical pharmacology strategy and decision-making.

Cross-Functional Collaboration

• Partner closely with Program Management, Clinical Operations, Clinical Science, Statistics, Regulatory, and Nonclinical teams.
• Work with the Head of Nonclinical to review protocols and ensure studies are executed as intended.
• Support integration of nonclinical and clinical pharmacology datasets, including translational analyses.
• Bring together internal teams and external consultants across pharmacology, DMPK, discovery, and statistics.

Regulatory & Documentation Support

• Support drafting of non-clinical and clinical pharmacology sections of protocols, CSRs, and regulatory documents.
• Ensure PK datasets and outputs meet standards for regulatory submissions.
• Prepare PK tables, figures, and listings for study reports and filings.

Qualifications:

• PharmD or PhD in statistics, data management, bioinformatics, or biological sciences.
• At least 6 years of drug development experience post-PhD.
• Strong background in DMPK, with meaningful exposure to and progression into clinical pharmacology.
• Hands-on experience with Phoenix WinNonlin for PK data handling and non-compartmental analysis.
• Deep understanding of bioanalytical workflows, PK data flows, reconciliation, and QC.
• Proven ability to manage vendors, timelines, and multiple concurrent studies.
• Knowledge of GCP, ICH guidelines, and bioanalytical principles.

Bonus points if you have:

• Experience supporting IND/CTA submissions and regulatory interactions.
• Familiarity with SDTM PK domains and data transfer specifications.
• Experience preparing data for internal modeling and external analyses.