Angion is a clinical-stage biopharmaceutical company focused on acute kidney injury, a potentially life-threatening condition without therapeutic options. Our lead clinical asset, ANG-3777, is engineered to activate the HGF/c-MET pathway, an important mechanism in organ repair. Angion is developing ANG-3777 to meet the high unmet medical need of acute kidney injury resulting from kidney transplantation and from cardiac surgery. We are currently conducting Phase 2 and Phase 3 clinical trials with improvement in kidney function as an endpoint. Angion’s robust pipeline includes ANG-3070, an oral small molecule in development as a potential treatment for fibrosis and other severe organ damage. Learn more at www.angion.com.
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 lead a high functioning Clinical Operations team and lead interdepartmental collaboration efforts to ensure alignment on goals and priories for the studies are clear and executable.
Responsibilities include and are not limited to the following:
- 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 closeout
- 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 the planning, design, and conduct of clinical trials
- Minimum of a bachelor’s degree in a related field with at least 15 years of experience in industry and 10+ years of leadership experience within clinical operations or related function with a 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 in 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.