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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 Translational Medicine team as Director of Non-clinical Development. The successful candidate will be responsible for leading the planning and execution of nonclinical safety programs for all programs. This individual will be responsible for the outsourcing, monitoring, and interpretation of GLP and non-GLP safety studies to support successful regulatory submissions and writing/reviewing/editing nonclinical development modules in regulatory submissions. This role will provide technical expertise and stage-appropriate guidance in toxicology and safety assessments for programs at all phases of early discovery through clinical development. 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:

• Design nonclinical PK/PD studies to answer translational questions in support of project deliverables and first-in-human dose predictions; oversee TK analysis for non-GLP and GLP toxicology studies.
• In collaboration with external consultants, develop and implement nonclinical toxicology and safety studies (GLP and non-GLP) to support company timelines and goals.
• Responsible for the execution of nonclinical toxicology and safety studies, including CRO selection, CRO management, and data interpretation to ensure successful regulatory submissions.
• Work collaboratively with Discovery, Pharmacology, Bioanalytical, CMC, Regulatory, Clinical, and Program Management functions to ensure successful nonclinical study execution to support clinical development.
• Lead review of nonclinical study reports by internal and external stakeholders for regulatory submission.
• Serve as a subject matter expert during interactions with regulatory agencies
• Lead preparation and review of nonclinical safety documents for regulatory documents, including briefing books, INDs, CTAs, investigator’s brochures, and NDAs.
• Ensure compliance with global regulatory nonclinical regulations and guidance.
• Serve as the nonclinical representative for projects at all stages of discovery and development and provide stage-appropriate guidance to project teams.

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 potentially 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

• Extensive experience with nonclinical study design, execution, and interpretation to support successful regulatory submissions.
• Knowledge of FDA and global regulatory guidance and requirements related to nonclinical safety assessments.
• Extensive experience with nonclinical CRO management including CRO selection, study design, protocol drafting and reporting.
• Strong understanding of Good Laboratory Practices (GLP), standard operating procedures, and stage-appropriate quality assurance.
• Ability to make data-driven decisions and demonstrated flexibility to adapt to modifications in project plans.
• Experience writing and reviewing nonclinical regulatory submissions (i.e.INDs, NDAs, CTAs, IBs, briefing books, etc.).
• Excellent written and verbal communication skills with the demonstrated ability to work with external stakeholders including consultants, KOLs, and CROs.
• Excellent organizational skills and comfort with multi-tasking in a fast-paced environment.

Qualifications

• An advanced degree (i.e. MS, PhD, DVM or equivalent) in toxicology, pharmacology, pathology, biology or related discipline
• A minimum of 8-10 years of related work experience in Non-clinical development
• Strong knowledge of non-clinical development processes, GLP guidelines, and regulatory requirements.
• Proven experience work with and overseeing CRO partners
• 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.