About the Role
We are seeking a highly motivated, proactive, strategic, and solution-focused Head of Clinical Operations. This hands-on position will lead and support all aspects of clinical trial operations including planning, implementation, execution, and management of clinical studies by overseeing day-to-day operations, including direct management of outside Clinical Research Organizations (CROs) for several clinical stage oncology assets. In this role, the Clinical Operations leader will manage multiple priorities in a fast-paced environment and enact quick problem solving to ensure the successful conduct of clinical trials and the timely delivery of high-quality data. This role will oversee early and late phase trials with an emphasis on proactivity and creative solutions to overcome regulatory and operational hurdles. The successful candidate will have experience, and interest in, working in a small, dynamic environment with broad responsibilities.
Responsibilities
- Develop and lead a team of clinical operations professionals to ensure high-quality execution of early and late phase clinical trials and the professional development of team members.
- Serve as subject matter expert in clinical operations, providing guidance and expertise to cross-functional teams, including clinical development, regulatory affairs, and data management.
- Provide operational expertise and strategic input to Clinical Development Plans and support the overall clinical strategy for clinical programs.
- Proactively communicate study plans, progress, risks and mitigations with senior leaders.
- Develop, implement, and modify when needed a successful resource and outsourcing model to meet the evolving demands of an expanding clinical portfolio.
- Manage study site selection, qualification, initiation, and monitoring activities to ensure that clinical trials are conducted according to the study protocol and in compliance with regulatory requirements.
- Evaluate and negotiate budgets, oversee selection and provide oversight and management of CROs, consultants and vendors to ensure the effective and timely execution of clinical trials, with high quality (including inspection ready) and within agreed budget.
- Monitor progress of clinical activity and report on the progress of clinical trials including budget, timelines, enrollment, and data collection / review.
- Participate in the creation, review, and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
- Coordinate the delivery of clinical trial supplies in collaboration with CRO and other company team members.
- Develop and maintain strong relationships with clinical investigators and study site staff to ensure site performance, patient enrollment, and data quality; perform periodic visits to sites and/or vendors to assess progress and compliance.
- Ensure clinical trials maintain an inspection readiness state throughout the lifecycle of the trial and provide subject matter expertise for regulatory inspections.
- Maintain knowledge across the clinical operations team of program specific therapeutic areas, current medical practice, and pharmaceutical regulations in order to ensure best practice across all activities and appropriate communication to study sites.
- Proactively implement process improvements and innovative approaches. Support the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes across the trials; ensures compliance with regulatory and other applicable standards and guidelines.
Qualifications:
- Bachelor’s degree (BA/BS) in a relevant scientific field (e.g. nursing, biology, biochemistry, or related areas); advanced degree preferred.
- At least 15 years of experience of successfully leading studies within clinical research operations. Experience with both small and large biotechnology companies is favorable.
- Experience in Phase I-III oncology clinical studies. Global experience preferred.
- Demonstrated expertise building and managing clinical operations teams.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
- Experience with agency submissions and inspections, understands adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations.
- Forward thinking mindset with ability to manage multiple projects, identify and resolve issues.
- Strong analytical, organizational, and time management skills with a track record of identifying and implementing novel solutions and problem-solving.
- Demonstrated agility and ability to navigate and be successful in a fast-paced, dynamic work environment.
- Proven hands-on leadership and communication skills (written and verbal).
- Team player who collaborates effectively with internal stakeholders as well as external contract organizations.
- Be a champion of a highly collaborative, transparent, data driven, “make it happen” culture.
This position is classified as exempt. The anticipated annual base salary range for candidates who will work in Watertown, MA is $319,333 - $375,665. The final base salary offered to the successful candidate will be dependent upon several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, education, and other factors. Treeline Biosciences is a multi-state employer, and this salary range may not reflect positions that work in other cities or states.
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The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.