Pandion Therapeutics is seeking a highly motivated results-oriented leader to lead our Clinical Operations organization. The selected candidate will have ownership over ensuring Pandion has world class clinical trial planning and execution in accordance with associated regulatory guidelines. They will be responsible for all aspects of clinical study conduct including site selection, contract negotiations, study start-up, real time data delivery, providing leadership and resolution of trial and/or program specific issues to deliver high-quality clinical trial results. This role reports directly into the Chief Medical Officer.
RESPONSIBILITIES, KNOWLEDGE AND SKILL REQUIREMENTS:
- Provide clinical operations leadership and oversight for all study activities including site identification and selection, enrollment models, clinical supply planning, CRO selection and negotiations, budget planning and trial execution.
- Provide strategic oversight and lead overall execution of clinical operations with a focus on quality, budget and timelines, including making decisions or recommending operational strategies in support of achieving clinical program objectives.
- Provide effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated clinical development plans and study protocols.
- Accountable for the review and expert clinical operations input into regulatory documents related to the drug development process. Provide expert clinical operations input into preparation for key regulatory meetings as appropriate.
- Ensure effective oversight of CROs and other third-party vendors and build highly effective relationships to produce quality deliverables.
- Lead the proactive identification, assessment, and management of clinical study challenges and risks. Provide systematic & ongoing updates to Pandion leadership.
- Accountable for program budget planning and external spend related to program execution. Works closely with Program Management and Finance to ensure budgets, enrollment, and gaiting are accurate; ensures communication of program status, cost and issues to inform timely decision-making by company leadership.
- Ensure compliance with all SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards in the conduct of clinical trial execution.
EDUCATION AND EXPERIENCE:
- 12+ years of relevant experience in a clinical operations function
- A minimum of a bachelor's degree; Masters preferred
- Previous experience overseeing and completing multiple complex, clinical studies across both early and later development.
- Experience with multiple successful regulatory submissions (NDA/BLA/MAA) reviews and approvals
- Extensive experience managing global CROs and other third-party vendors in support of clinical trial execution.
- Strong verbal and written communication skills
- Strong attention to detail and creative problem-solving skills are essential
- Demonstrated excellence in project/program management and matrix leadership
- Support a culture of continual improvement and innovation; promote knowledge sharing
Pandion Therapeutics was founded in 2017 with the mission to develop bispecific antibody therapeutics that act at the local site of disease, offering the potential for significantly improved therapeutic options beyond systemic immunosuppressive treatments We aim to shift the paradigm and create a new generation of drugs with transformative efficacy and improved safety to treat immune-related conditions such as inflammatory bowel disease, type 1 diabetes, and autoimmune liver, kidney and skin diseases. Pandion was recently recognized as a 2018 Fierce 15 Winner.
Pandion Therapeutics is committed to diversity, and proud to be an equal opportunity employer. All qualified candidates will be considered for employment, regardless of race, color, age, ancestry, religion, national origin, gender, gender identity, genetic information, parental or pregnancy status, sexual orientation, citizenship, marital status, disability, or Veteran status.