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Why join Cardurion Pharma?

We are a clinical-stage biotechnology company discovering and developing new therapeutic approaches to treat cardiovascular disease. We have built a pipeline of novel therapeutic product candidates that have the potential to address the significant morbidity and mortality that remains for patients suffering from cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing towards our goal of building a world-class biotechnology company that discovers, develops and commercializes life-changing therapeutics for patients with cardiovascular disease.

The Role:

We are seeking a highly motivated, goal-oriented team player to join Cardurion’s Clinical Operations team as Director Clinical Outsourcing. The successful candidate will be responsible for developing and managing outsourcing strategies to support Cardurion’s clinical trials across multiple Clinical Programs and indications. This role is accountable for leading the selection, negotiation and financial oversight of external vendors, including CROs, central labs, clinical drug supply vendors and specialty service providers. These activities are coordinated in conjunction with the respective Clinical Operations team members. The successful candidate will exhibit a data-driven mindset with strong teamwork, a positive attitude, and values bringing important medicines to patients in need.

Here’s What You’ll Do:

• Develop and execute a comprehensive outsourcing strategy to support clinical trial needs.
• Establish standardized governance metrics and meeting requirements for optimized relationship management with key CROs and vendors.
• Identify opportunities to optimize vendor selection and management processes to improve timelines, quality and cost-efficiency.
• Lead the identification, evaluation, and selection of external vendors, including CROs, central labs, and other clinical service providers.
• Oversee the development, negotiation, and execution of contracts, master service agreements (MSAs), work orders, and budgets.
• Ensure that vendor contracts align with company policies, regulatory requirements, and industry best practices.
• Establish budget management standards for Clinical spend and liaise with Finance on routine budget reviews, forecasting and accruals, new study ballpark costing, and act as the financial SME for Development.
• Partner with additional Development functions to establish best practices for budget management and oversight as appropriate, including but not limited to Drug Supply and Translational Medicine.
• In partnership with Clinical Operations and cross-functional SMEs, establish KPIs and metrics to measure vendor performance and ensure service level agreements (SLAs) are met.
• Conduct regular vendor performance reviews to assess quality, timelines, and cost-effectiveness.
• Address performance issues, escalate concerns when necessary, and drive continuous improvement initiatives.
• Collaborate with Clinical Operations and Finance teams to manage clinical trial budgets related to outsourced services.
• Track and report on vendor-related expenses, ensuring compliance with financial controls and forecasting.
• Ensure all vendor activities comply with regulatory guidelines (FDA, EMA, ICH-GCP) and company policies.
• Identify and mitigate outsourcing risks to ensure successful execution of clinical trials.
• Collaborate with Clinical Operations, Regulatory Affairs, Legal, Quality Assurance, and Finance teams to ensure alignment on outsourcing strategies.
• Act as the primary point of contact for vendors, ensuring clear communication and issue resolution.
• Participates in the preparation of study budgets; negotiation of contracts and vendors; supports accrual review, invoice review through payment.
• Continuously evaluate and improve the outsourcing process to increase efficiency, reduce costs, and enhance quality.
• Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials.
• Support inspection readiness activities as related to key vendor scope and sponsor oversight.

Here’s What We’ll Bring to the Table:

• Highly competitive benefits package including: Blue Cross Blue Shield PPO, Delta Dental, and VSP vision
• Fully funded HSA for high-deductible PPO Plan
• 401k (traditional and Roth offered) with 100% match on first 4% deferred. Match is vested immediately
• A suite of Cardurion paid insurance coverage, including: life insurance, short-term and long-term disability
• Flexible Spending Accounts for medical and dependent care expenses
• 4 weeks Paid Time Off annually
• 11 company paid holidays and Year-End shut down

Translate our world-class expertise in cardiovascular signaling pathways into groundbreaking therapeutics for patients.

Cardurion is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Cardurion will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Here’s What You’ll Bring to the Table:

Core Competencies

• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
• Possesses a broad view of the departmental goals and sees the “big picture” scientifically and strategically.
• Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks under limited direction.
• Effective time management and organization skills with ability to multi-task and shift priorities quickly while working under tight deadlines.
• Must have excellent interpersonal, written and verbal communication skills.
• Skilled in developing collaborative internal and external relationships.
• Ability to effectively communicate, collaborate, and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.

Qualifications

• BS or BA in Life Sciences, Business or related field (Advanced degree preferred).
• A minimum of 10 years of related work experience in Clinical Outsourcing, vendor management or Clinical Operations within the Pharmaceutical, Biotech or CRO industry.
• Strong knowledge of clinical trial processes, GCP guidelines, and regulatory requirements.
• Proven experience negotiating contracts and managing vendor relationships.
• Excellent project management, organizational, and communication skills.
• Ability to lead cross-functional teams and manage multiple projects simultaneously.
• Strong analytical and problem-solving skills with attention to detail.