- Job Type: Full-Time
- Function: Operations
- Industry: Biotechnology
- Post Date: 09/20/2022
- Website: synthekine.com
- Company Address: 1505 Obrien Drive, Suite A/D, Menlo Park, California 94025, US
About SynthekineSynthekine is an engineered cytokine therapeutics company developing disease-optimized treatments. The company uses immunological insights to guide targeted protein engineering to generate transformative medicines for cancer and autoimmune disorders.
The Head of Development Operations will report to the CMO and function as a strategic leader of the Development Operations group, accountable for key high-level management, establishing new processes and procedures, and adherence to industry best-practices, Synthekine’s SOPs, and applicable regulations and Good Clinical Practice (GCP). This role maintains oversight of the operation of all clinical programs including project planning, budget, resource management, and management of contract research organizations (CROs) and other key vendors. This individual represents departmental and corporate management to ensure appropriate fiscal oversight, including management of vendor scopes-of-work and change orders, and recommends and implements innovative ideas to impact clinical trials management. This role oversees clinical trials staff both internally and at service providers and manages all aspects of study operations at both the project and the department levels. As a member of the Clinical Leadership Team, this individual acts as a cross-functional leader to ensure study plans appropriately support research questions and other goals of the company and participates in development-wide discussions to resolve differences with other functional areas within Clinical. The Head of Development Operations ensures a positive, collaborative team environment and escalates issues to the CMO and other functional area Heads as appropriate.
- Responsible and accountable for defining clinical operating plans for development projects; manages resources, timelines and budgets for global clinical programs to ensure clinical and corporate goals are met or exceeded
- Oversees the identification, selection and management of external resources and vendors, from full service CROs to contract monitors
- Responsibility and oversight for data management, and medical writing as the function matures. May oversee biometrics.
- Acts as an escalation path and general point of contact for CROs and other vendors as needed; represents the company on periodic vendor calls and ensures CRO and internal personnel adhere to project specifications with particular attention to timelines, costs, and quality of deliverables
- Oversees critical decision-making among key stakeholders including Synthekine personnel, scientific advisers, and vendor representatives; escalates issues to the CMO, and/or other functional area Heads appropriately; provides input to other functions in the organization and is responsible for identification, prioritization, and definition of new processes as organizational complexity expands
- Responsible for the day to day management of the Development Operations team as well as training and development of this team (SOP’s; GCP, ICH and federal regulations etc.); plays a key role in managing the growth of the Development Operations team, including the identification of resource needs, presentation of headcount requests to the CMO and HR representatives as needed, and leading the interviewing and on-boarding processes affecting direct reports and other staff as required
- Supports creation of key study documents including study protocols, ICFs and applicable study plans both with other Synthekine teams and vendors
- Ensures that participating investigators adhere to Good Clinical Practice and applicable regulations by ensuring timely review of monitoring visit reports by appropriate staff and participates in direct engagement with CRO personnel and Synthekine Clinical Quality Assurance as needed; acts as a point of escalation for any significant compliance issues, and escalates issues as needed to the CMO, and other functional area Heads for resolution
- Ensures that proper processes are adhered to regarding the initiation, conduct and closeout of all US run studies as well as the maintenance of the Trial Master File for such trials; takes personal responsibility for ensuring regulatory compliance and delivery of high-quality data via all appropriate means
- Supervises national regulatory and IRB/Ethics Committee submissions and responses to questions as required
- Reviews and contributes to Clinical Study Reports, INDs, NDAs, and other clinical and regulatory documents
- Represents the company as needed at professional meetings and presents clinical operations materials and provides training at such events as needed
- Provides leadership in the development and documentation of departmental policies and procedures toward increased efficiency and quality of deliverables; contributes directly to the development of SOPs and other procedural documents
- Develops, implements, and oversees mechanisms for appropriate reporting of the progress of clinical programs to the CMO and Senior Staff
- Direct supervision/management of assigned Development Operations team members
- Acts as a mentor to all Development Operations team members
- Bachelor’s degree, preferably in a scientific or health-related discipline
- Minimum of 15 years of clinical and related experience with at least 8 years of clinical trial management experience in an industry setting such as a CRO or pharmaceutical/biotech company; trial management experience gained at academic or other not-for-profit institutions involved in industry-sponsored research may supplement this requirement at the discretion of the hiring manager
- Excellent understanding of Good Clinical Practice and FDA regulations; Ex-US regulatory knowledge/experience, particularly in Europe, is highly desired
- Clinical experience/background (e.g. RN, PA, or medical office) a plus
- Demonstrated ability to develop positive working relationships with individuals and teams both inside and outside the company
- Must have proficiency with MS Office as well as demonstrated ability to learn other project management and clinical trial software as required
- Demonstrated ability to work independently, escalate issues appropriately, and to ensure a solutions-oriented approach to the identification and mitigation of risks to project milestones, budgets, and quality
Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.