Sr Director, Clinical Operations

Forward Tx is currently seeking:
A Senior Director, Clinical Operations who is a highly motivated, patient-focused, results-oriented leader for our Clinical Operations organization. The Senior Director, Clinical Operations will build, develop and lead a high performing team of clinical trial managers and associates; provide operations leadership at the program level, including development and implementation of clinical development plans, study protocols, resourcing; managing execution and overall management of clinical studies as well as oversight of CRO and vendors; and provide cross functional leadership of development operations initiatives. The Senior Director, Clinical Operations will report to the Chief Medical Officer

How You’ll Contribute to the Team…

• Study Management may include first-in-human, early and mid-stage clinical trials of development candidates
• Responsible for the planning, implementation, and management of clinical studies by overseeing day-to-day operations and directly managing and working with outside Clinical Research Organizations (CROs)
• Initiate and lead monitoring oversight activities as conducted in accordance to Company and ICH/GCP standards
• Oversee the development of clinical trial project timelines and ensure communication and understanding of risks and challenges
• Proactively manage clinical trial outsourced partners, including identification of risk, to ensure trial deliverables and performance goals are met on time and on budget
• Work cross-functionally to coordinate the relevant and timely exchange of information and materials to support clinical trial deliverables
• Manage the scope of work, change notifications, contract modification, site trial agreements, and other necessary budgetary information for clinical trial operations
• Collaborate with CROs to keep the clinical study database current and accurate
• Maintain partnerships with CRO counterparts; proactively review and identify potential issues or problems with the sites and communicate/escalate to clinical leadership
• Support and manage oversight activities of all necessary vendors to ensure a high level of operational excellence is maintained
• Maintain oversight and participate in the review of departmental SOPs to ensure compliance
• Oversee activities leading to internal GCP audits and regulatory inspections related to clinical trial conduct
• Along with other Forward Tx personnel, represent the Company externally to Investigators and trial site administrators
• Experience building and/or managing teams

What You Bring with You…

• MS/MA degree in relevant discipline; PhD a plus but not required
• 10+ years of experience in clinical operations and/or consulting in the healthcare space
• Healthcare services experience strongly preferred, and immunology experience ideal, with familiarity with the payer, provider, healthcare IT, and distributor landscape
• Experience in value-based care and with alternative payment models also strongly preferred
• Highly proficient in Excel and PowerPoint, with experience in electronic medical record and practice management systems
• Excellent written and oral communication skills with a proven ability to lead discussions with physicians and C-suite provider executives
• Global experience is preferred

EEOC Statement…
Forward Tx Therapeutics, Inc. is an equal opportunity employer committed to building a diverse and inclusive organization. We measure each applicant, candidate and employee based on their qualifications for the role, regardless of age, sex, religion, sexual orientation, gender identity, national origin, Veteran status, disability, and/or any other protected class characteristics. Furthermore, Forward Tx is committed to achieving all business objectives in compliance with all federal, state, and local laws.