Vice President Clinical Operations

Vice President Clinical Operations

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Job Description

Angion is seeking a dynamic leader to head our clinical operations group. Reporting to the Chief Medical Officer, the ideal candidate will have a strong background and deep knowledge in clinical operations as well as strong organizational and leadership capabilities. The core deliverables include developing strategies to optimize our clinical programs across all phases of their development. We operate in a fast-paced, multi-location environment so being able to shift priorities and think on your feet is required. This role will leada high functioning Clinical Operations team and lead interdepartmental collaboration efforts to ensure alignment on goals and priories for the studies are clear and executable.

• Define strategic direction for an integrated project team for all the indication/clinical development programs
• Lead operational resource planning, implementation, and execution to support multiple global clinical trials
• Develop, maintain, and report on program budgets, including forecasting in support of financial goals
• Define and help manage the development of clinical study protocols, documents, procedures, study reports, charters, presentations, and publications
• Manage clinical study managers, project leads and clinical monitors (both internal and external)
• Design and lead the ‘buy or build’ for team resources to optimize execution
• Create team study training, tools and metrics and monitor accordingly
• Oversee Quality Management for all aspects of GCP and ‘inspection readiness’
• Identify outsourcing model best suited for clinical development success

• Identify vendors, perform capabilities assessments, and conduct formal request proposal process (RFP) including summary evaluation of key factors and bid defense
• Oversee process and performance management of vendors (clinical, pre-clinical, Drug supply) from pre-bid through close out
• Act as point of contact for escalation management of external vendors and/or CROs
• Prepares and presents trial parameter and clinical operations information to senior management, vendor and other key stakeholders
• Involved in building relationships with trial site and KOLs to maximize scientific expertise, patient recruitment and data collection
• Ensures advocacy and voice of the patient is represented in planning, design and conduct of clinical trials

Qualifications

• Minimum of a bachelor’s degree in related field with at least 15 years of experience in industry and 10+ years of leadership experience within clinical operations or related function with proven record of accomplishment of people and project management.
• Solid knowledge of ICH/GCP, regulatory guidelines and drug development process.
• Experience with NDAs, MAA, or other agency new drug application submissions
• FDA. MHRA or other regulatory agency inspection experience highly desirable.
• Global clinical trials/program management experience
• Track record of excellence in effective management of multiple projects/priorities and budgets, ranging from early to late stage development programs.
• Understanding of comprehensive global pharmaceutical regulatory requirements and strategic implications for clinical development operations.
• Extensive experience with vendor oversight and managing external partnerships and relations.
• Demonstration of strong leadership and management abilities.
• Extensive experience managing clinical operations staff.
• Proven ability to lead multifunctional teams and mentor junior staff.
• Ability to remain calm and navigate in a fast-paced and ever-changing small company environment.
• Commitment to the highest standards of patient management and clinical research.
• Excellent verbal, written, interpersonal and presentation skills.

Additional Information

At Angion, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.

Angion is an equal opportunity employer. Angion makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.

Angion acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Angion’s Human Resources Team and comply with Angion’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Angion. Angion’s Human Resource Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Angion will become property of Angion and Angion will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.

Candidates must be authorized to work in the U.S.

Angion offers a competitive compensation and benefit package.

Angion is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.