ARGOS IS GROWING!
After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified Head of Clincal Operations.
This is an exciting opportunity to join a growing entrepreneurial biotech to build out the clinical operations function, prepare for successful regulatory filing for the company’s first Phase III asset and initiate a number of Phase II studies. The selected candidate will oversee the direction, planning and execution of company and investigator initiated (ISTs) clinical trials. Responsible for managing and executing assigned clinical trials with the highest quality within established timelines and on budget. Oversees the development and proper maintenance of clinical files and documents and oversees data collection and processing activities across all clinical trials. Routinely interacts with internal (Mfg, Quality, Regulatory, Immunology, R&D) and external (Investigators and staff, CROs, clinical consultants) stakeholders to support achievement of clinical program and trial objectives. Selects, develops and evaluates clinical operations team members to support department and company objectives.
- Manages overall operations of assigned clinical trials (company and investigator initiated) including project planning, project timelines, project budget and expenses, resource management, as well as CRO/outside clinical consultants, to ensure project work delivered on time, on budget and according to company expectations and industry practices.
- Establishes and oversees priorities, deliverables and work load for clinical operations team (eg., clinical trial associates/coordinators, clinical trial/project managers, etc).
- Develops and/or maintains SOPs and processes within Clinical Operations to support company and investigator initiated trials.
- Routinely and effectively works with cross functional team members from Manufacturing, Quality, Regulatory, Medical Affairs and R&D/Immunology to ensure overall clinical program objectives are met and aligned with company strategy and objectives.
- Oversees and manages the selection, negotiation and monitoring of all outsourced service providers to facilitate achievement of clinical program objectives (time, quality, cost)
- Oversees the development and completion of key clinical files and documents (protocols, ICFs, CRFs, study manuals, IBs, CSRs and other study related materials and forms).
- Reviews monitoring reports and other study-related documents from vendors to ensure trial expectations are met.
- Maintain knowledge of evolving clinical and regulatory environment and ensures all product safety related documentation is properly obtained and submitted in coordination with regulatory lead on a timely basis
- Ensures senior management team routinely informed and aware of clinical trial progress and challenges.
- Attends key scientific meetings to establish and maintain relationships with investigators, site staff and other groups to ensure the success of ongoing or planned clinical trial activities
- Delivers effective presentations and builds internal support and awareness of the Clinical Operations function
- Other duties as requested.
- Advanced degree in a related discipline preferred, with at least a Bachelor’s degree in related discipline
- Must possess a minimum of 10-15 years of experience in clinical research, including a minimum of 5 years leading the Clinical Operations function, including direct oversight and management of employees
- Prefer direct CRO and Sponsor side experience in clinical operations capacity
- Experience with specialty pharmaceuticals/ biopharmaceuticals biologics drug development is required, experience in oncology drug development strongly preferred.
- Ideal candidate will possess direct experience supporting a successful BLA/NDA filing from a clinical perspective
- Thorough knowledge of the drug development and clinical research processes, FDA/ICH GCP regulations and guidelines.
- Strength in core leadership skills of sense of urgency, drive for results, taking initiative, managing complexity and dealing with ambiguity.
- Excellent written and verbal communication skills and sound interpersonal skills.
- Demonstrated ability to identify, manage and motivate direct reports.
- Excellent presentation skills at conferences, meetings, training sessions.
- Outstanding project management, negotiation, and organizational skills.
- Demonstrated track record of collaboration skills with a willingness to work in a matrix environment and to value the importance of teamwork.
- Track record of effectively building strong relationships with external partners and through those entities, delivering high quality results.
- Proficiency with Microsoft based applications, various CTMS and EDC platforms, etc.
- Ability/willingness to travel as required (approx. 20%)
We offer a competitive compensation package along with outstanding benefits. For confidential consideration, please submit a resume with a cover letter and salary history.
No phone calls please.
Argos Therapeutics is an Equal Opportunity Employer.