Director/Sr. Director, Clinical Operations
At TFF Pharmaceuticals, we transform how medicines are developed and delivered by leveraging our proprietary Thin Film Freezing technology. Our novel drug delivery technology, Thin Film Freezing, is designed to make treatments available to patients as safely and efficiently as possible. Maintaining the highest standards of performance, professionalism, ethics, and integrity is vital to our efforts to transform the drug delivery and development landscape.
Our strategic approach includes both internal clinical development programs and out-licensing activities in which we provide formulation and process solutions to improve stability and delivery properties of current and new treatments.
Our highly experienced and motivated team is committed to collaborating widely, fulfilling our vision of unlocking the potential of a diverse array of therapies across many disease areas. Our guiding mission is to enhance health and to improve the lives of people around the world.
Our Pipeline: https://tffpharma.com/programs/
As a Director/Senior Director, Clinical Operations, you will serve as a key member of the Clinical Development Team to advance the TFFP mission and vision. You will provide operational leadership and expertise in the implementation and execution of clinical study programs, ensuring the timely completion of deliverables and collection of high quality data through the development and management of the project timelines and budgets.
This is an opportunity to:
- Provide operational leadership for one or more clinical studies.
- Lead clinical operations strategic planning activities for clinical programs and translate strategic decisions into actionable operational plans
- Translate corporate and product development goals into relevant, tangible and measurable objectives for the operational team and third party vendors and drive optimal delivery
- Lead the operational selection of various vendors and the review of proposal requests
- Contribute to clinical trial design. Bring operational insights into protocol design
- Lead site selection, oversee site activation, explore ways to facilitate trial enrollment.
- Manage clinical trial implementation with clinical sites, external consultants and CRO personnel to ensure timely implementation of clinical studies in accordance with GCP regulatory requirements
- Develop key study documents including informed consent forms, study manuals (including operational manuals), study plans (communication, escalation, oversight) and tools
- Provide oversight for CRO and other vendors, monitor quality to
- Follow clinical trial data to ensure accuracy, implement appropriate data cleaning processes and lead data cleaning practices on an ongoing basis
- Oversee and coordinate budgetary activities for assigned programs including study budget creation, forecasting, accruals reporting and invoice approval
- You have a BS Degree and 8+ years of experience in clinical development
- You are passionate about improving patients’ lives and the TFFP mission
- You are a multi-tasker and detail oriented. You thrive in a fast pace environment
- You have a strong therapeutic expertise in pulmonology/respiratory medicine, infectious disease, hematology/oncology, transplant or immunology
- You have experience leading cross-functional project teams in phase 1-4 clinical studies
- You have experience managing and providing oversight of clinical studies outsourced to third party vendors (CROs, central labs, IWRS, clinical supplies etc.)
- You have effectively managed interactions between functional groups such as monitoring, data management, biostatistics, medical writing, safety, regulatory affairs and QA.
- You thrive in building and maintaining relationships with clinical investigators/advisors/thought leaders, and you collaborate with key stakeholders internally and externally to understand the global therapeutic landscape