Director of Clinical Operations
Location: Waltham, MA
Palleon Pharmaceuticals is seeking a Director of Clinical Operations to provide leadership, and strategic and operational oversight of all clinical operations. Reporting to the CMO, the Director will be accountable for meeting milestones and company goals while keeping costs under control. They will oversee timeline, budget, quality, resourcing, and risk management. The Director will supervise the activities of Clinical Research Organizations (CROs) and other vendors in the conduct and management of clinical trials. This is an excellent opportunity for a highly motivated self-starter and creative problem solver who has a strong desire to make an important contribution to the development of novel biologics. The Director of Clinical Operations will be a high profile, leadership position with the opportunity to innovate in an entrepreneurial and high growth organization.
- Support the program lead by establishing and executing development strategies for assigned clinical program(s).
- Provide strategic and operational oversight for and execute the clinical studies for one or more programs.
- Oversee clinical operations in the identification of potential challenges or risks associated with clinical study conduct, and the implementation of mitigation plans.
- Develop and execute the clinical site engagement and subject recruitment strategies for assigned clinical program(s).
- Resolve and/or escalate issues raised by the clinical operations team.
- Take a lead role in vendor selection, including soliciting requests for proposals, leading bid defense meetings, critically reviewing contracts, and negotiating work orders.
- Oversee CROs and other selected vendors on a product level, including setting and monitoring key performance indicators, ensuring successful execution of the clinical program/studies, and co-leading operational governance meetings.
- Act as the main escalation point of contact for strategic CRO partner(s) and for other key stakeholders in clinical operations.
- Ensure consistency between studies for assigned clinical program(s).
- Provide input to and clinical operations perspective on clinical trial design.
- Create and/or provide input to and/or oversee program level and study level documents that support clinical studies and regulatory submissions.
- Oversee financial aspects of assigned clinical program(s), prepare related operating plans, and ensure adherence to planned study budgets.
- Oversee/co-lead inspection readiness activities and act as the subject matter expert during regulatory inspections.
- Lead the development of SOPs.
- If appropriate, attend advisory board meetings and regulatory agency meetings related to strategy of the program, indication, and/or studies.
- Oversee resource planning for assigned clinical program(s).
- Bachelor of Science (BS) or higher degree in a relevant scientific discipline required.
- Significant experience (10+ years) in clinical research/clinical operations and organizational management within the pharmaceutical industry (biotech/small pharma experience preferred).
- Global clinical trial research experience preferred.
- Experience in oncology preferred.
- Demonstrated ability to lead, motivate, and mentor staff and cross-functional teams.
- Previous line management or direct management of team members.
- Demonstrated ability to present complex information to management, vendors, and external audiences.
- Demonstrated ability to create and manage one or more program budgets including communication of overspend/underspend.
- Demonstrated ability to manage and communicate effectively with vendors including negotiating contracts, drafting and reviewing request for proposals, analyzing scope of work, and responding to inquiries and complaints.
- In-depth knowledge of current regulatory requirements and guidelines governing clinical research (e.g., ICH/GCP).
- Demonstrated ability to work in a fast-paced environment with multiple competing tasks and demands, across time-zones.
- Demonstrated ability to work independently, take initiative, and complete tasks on time.
- Excellent written and oral communication skills.
- High level of professionalism with internal and external stakeholders.
Who We Are:
Palleon Pharmaceuticals is the leading biotechnology company developing drugs that target glycan-mediated immune regulation to treat cancer and inflammatory diseases. The company’s proprietary platforms integrate technologies and insights from global scientific leaders in the glyco-immunology field to overcome historical scientific hurdles and create novel therapeutics for devastating diseases characterized by immune system dysfunction. Palleon’s lead program in oncology, an enzymatic sialoglycan degrader for T cell exhaustion in cancer, is expected to enter clinical testing in 2021. The company has several other drug discovery programs underway in disease areas where glycan-mediated immune regulation plays a role, including inflammatory diseases such as autoimmunity and fibrosis. Palleon was launched in 2015. The company recently raised a $100 million Series B financing from leading investors Matrix Capital Management, Surveyor Capital (a Citadel company), SR One, Pfizer Ventures, Vertex Ventures HC, Takeda Ventures and AbbVie Ventures. Learn more at www.palleonpharma.com.