The Senior Director, Clinical Operations Strategy and Operations will be responsible for oversight and implementation of best practice clinical process design and improvements to ensure compliance, quality and efficiency across Clinical Development initiatives. The incumbent will participate and drive the overall strategic activities for Retrophin clinical management to ensure alignment and proper execution of the strategic plan across all functions under the supervision of the CMO.
- Lead/support various clinical development cross-functional working groups and committees.
- Close collaboration with the Clinical Development and Regulatory teams in pull through of key clinical development initiatives including planning and execution of upcoming regulatory submissions.
- Establish and facilitate review committees for clinical deliverables, including study outlines, protocols, study reports and clinical-focused regulatory documents.
- Lead key activities, including, but not limited to, compassionate use and early access programs.
- Liaison between Clinical Development and Medical Affairs to ensure key projects and processes are strategically and operationally aligned.
- Work closely on collaborative projects with Clinical Development and other departments for planning and execution of clinical development studies and scientific advisory board.
- Collaborate with Clinical Development colleagues to guide and execute therapeutic area strategy and tactics with appropriate use of resources.
- Participate and assist Medical Directors in assessment and design of scientific strategy.
- Lead conference planning efforts from a clinical development perspective aligning with medical affairs, commercial and clinical teams.
- Participate in cross-functional teams to represent clinical development strategy and tactics.
- Assist in developing a departmental and corporate training curriculum.
- Partner with the CMO in strategic planning, corporate updates and business development analysis.
- Bachelor’s degree in a life science, pharmacy or related discipline. Advanced degree is preferred.
- Minimum of 12 years of clinical operations experience in a pharmaceutical organization, including at least 2 years in a leadership role.
- NDA and/or early access/compassionate use experience a plus.
- Experience actively managing phase I, II and III studies and has served as a clinical operations lead for multiple studies or within a program, or closely relevant experience is preferred.
- Global trial management experience required.
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP.
- Strong project management skills.
- Proactive, self-starter who possesses exceptional multi-tasking and communication skills, both oral and written.
- Good problem-solving and collaborative skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
- Ability to travel 10-20%.
Requisition ID : 1201