About Us:
At BlossomHill Therapeutics, we are on a mission to redefine precision medicine and make a leap forward in life expectancy and quality of life for patients.
Our cancer therapies are exquisitely designed to be potent against cancer drivers and aim to address cancer’s resistance to treatment from multiple angles. Our autoimmune programs seek to tackle difficult challenges to deliver life-changing therapies for patients.
Driven by a desire to transcend incremental improvements to existing drugs, we approach drug design from the ground up. Combining human intelligence, creative thinking, and proven drug design expertise, we are dedicated to developing small-molecule masterpieces that have the potential to set new standards for cancer and autoimmune disease treatment.
Position Summary:
The Senior Director/Executive Director of Clinical Operations is responsible for study planning, operations, financial oversight, vendor management and people management, and advancing company goals through actively contributing to clinical development strategy.
Key Responsibilities:
- Provide oversight of the overall clinical operations strategy, execution, and management of clinical studies within the Company’s portfolio.
- Supervise and direct clinical trials ensuring their timely completion within budget, and adherence to SOPs and Regulations.
- Devise and implement budget, cost controls, and resource planning to meet corporate objectives.
- Recruit, mentor and manage junior clinical operation staff, [PZ1] including Identify and evaluate contractors to successfully execute clinical studies, including but not limited to, negotiating pricing and timelines with CROs, sites, central laboratories and other vendors as applicable.
- Act as the primary contact with CROs and other vendors for study related matters including, but not limited to, clinical planning, patient recruitment, compliance with protocols, and monitoring of progress from start-up through final study report writing.
- Plan the study operation strategy, including vendor selection, study footprint planning, country/site prioritization, study activation/close out strategy. Establish critical timelines and direct the activities of employees, CROs, vendors, other collaborators, clinical sites, and clinical investigators to meet required deadlines and target goals.
- Direct, coach, and evaluate the operational activities of operational staff.
- Review and approve vendor invoices, manage monthly accruals, end ensure timely payment processing.
- Work with data management team on eCRFs for appropriate content, clarity, completeness, and performance in accordance with protocols and data requirements.
- Work with contracted IVRS/IP management vendor to incorporate enrollment/randomization strategy into clinical operational activities as applicable.
- Ensure timely and accurate data capture by sites, and promptly address anomalies or delayed entries through communications with CRO, CRAs and sites as applicable.
- Maintaining clinical records in clear and required formats.
- Aid in the preparation of clinical sections for all regulatory filings (IND, Annual Reports, AE/SAE reporting, study reports, etc.).
- Influence collaborators and consultants by demonstrating a deep understanding of all aspects of the company’s projects, data, results, and objectives.
- Improve quality results by studying, evaluating, and re-designing processes and implementing changes that augment the company’s mission, vision, values, and goals, including the development and ongoing review of department SOPs and working practices.
- Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
- Follow and apply appropriate laws, regulations, policies, and procedures.
- Perform other duties as assigned by supervisor.
Qualifications:
- B.S. in scientific or business-related field.
- 15+ years of clinical operations experience including leadership role in conduction of Phase 1-3 multinational studies (Oncology experience strongly preferred).
- Minimum 8 years in study management and 5 years in people management.
- Strong knowledge of FDA guidelines including IND and GCP regulations.
- Experience in conducting international studies.
- Proficiency in Electronic Data Capture, Clinical Trial Management Systems and Trial Master File Maintenance.
- Ability to communicate and collaborate with vendor CROs.
- Ability to exercise independent judgment and discretion.
- Demonstrate a high level of leadership and professionalism to build external relationships crucial to the success of the organization.
- Strong attention to detail, organizational, time management, and communication skills.
AAP/EEO Statement
The company provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Candidates only; please do not contact if you are a recruiter.
