Associate Director, Clinical Operations - Lifelancer

Description

Why join Cardurion Pharma?

At Cardurion, we are advancing the understanding of signaling pathways that regulate heart cell function. Our programs seek to modulate these pathways to reverse the pathophysiological mechanisms that drive cardiovascular disease. We invite you to explore our website to learn more about our Company and how we are advancing our drug candidates to improve health outcomes and impact lives around the world.

The Role

We are seeking a highly motivated, goal-oriented team player to join Cardurion’s Clinical Operations team as Associate Director, Clinical Operations. The successful candidate will be responsible for effectively contributing to Clinical Operations strategies and delivering successful operational outcomes across one or more clinical trials, and for facilitating decision-making within Cardurion at all levels and in partnership with all functions of the organization. The role is accountable for the day-to-day operational oversight of one or more clinical studies including study start-up, conduct, and close-out activities in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP) and other applicable regulatory requirements. The Associate Director will display leadership and oversight of functional subject matter experts and Contract Research Organizations (CROs). 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

• Ensure that Good Clinical Research Practice (GCPs) and clinical SOPs are met throughout the clinical trials/programs.
• Ensure successful conduct and completion of clinical studies within budget and on time.
• Leads the multidisciplinary study execution team and collaborates with other functions as required for implementation and execution of the study(s)
• Serves as the primary Clinical Operations point of contact for cross functional team members and CROs, as appropriate.
• Devises efficient, effective and proactive clinical trial execution strategies; guides planning and execution of clinical studies.
• Prepares and/or reviews/approves study-related documents including, but not limited to, Protocols, Informed Consents (ICFs), study plans and manuals, CRF Completion Guidelines, Clinical Study Report (CSR), and NDA submission documentation, as appropriate.
• Prepares metrics and updates for Leadership, as appropriate.
• Proactively identifies, negotiates, and successfully engages the study team in the resolution and/or mitigation of clinical study risks, issues, and challenges and escalates to leadership when appropriate.
• Participates in the preparation of study budgets; negotiation of contracts and vendors; supports accrual review, invoice review through payment.
• Participates in CRO/vendor Request For Proposal (RFP) and selection process for outsourced activities.
• Manages CRO/Clinical Service Providers (CSPs) interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, Trial Master File).
• May serve as a line manager to one or more Clinical Trial Managers (CTMs) and/or Clinical Trial Assistants (CTAs).
• Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials.
• Organizes, leads, and manages internal team meetings, investigator meetings and other study-specific meetings as appropriate.
  
  

Here’s What We’ll Bring To The Table

• Highly competitive package with healthcare coverage including medical, dental and vision
• Fully funded Healthcare Savings Account for high-deductible PPO Plan
• 4 weeks paid time off annually
• 10 company paid holidays and year-end shut down
• 401k (traditional and Roth offered) with company match
• 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
  
  

Our Mission:

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.

Requirements

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 a relevant scientific or health related field.
• A minimum of 7 years’ related work experience in the pharmaceutical or biotechnology industry, with at least 4 years in a study oversight role.
• Knowledge of FDA and/or EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
• Experience in managing CROs and external vendors including financial oversight.
• Experience in study financial management and knowledge of the CRO contracting and budget approval process.
• Demonstrated proficiency in MS Office (Outlook, MS Word, Excel, PowerPoint); MS Project a plus.