Blend Therapeutics is seeking high-energy, talented people who want to work in a collaborative team environment to discover and develop innovative new medicines that will make a meaningful difference for patients.
Blend Therapeutics is a biopharmaceutical company discovering new classes of medicines to treat debilitating diseases. We are pioneering an integrative way to discover molecular entities with new mechanisms of action purposely designed for our proprietary nanoparticles. By synergistically developing both the molecule and the nanoparticle together we can make medicines more targeted, effective and tolerable.
The Director of Clinical Operations will manage all aspects of clinical and data operations including the oversight of study management, clinical monitoring, adverse event reporting, ongoing safety review, protocol design, protocol adherence and ICH/GCP compliance. The Director of Clinical Operations will also be responsible for the development and management of timelines and budgets related to clinical trials in collaboration with management and cross-functional teams.
Summary of responsibilities:
- Assure high quality and timely execution of clinical trials from protocol development through clinical study report in conjunction with appropriate internal departments and external collaborators.
- Assure integration and coordination of clinical trial management, clinical trial monitoring, clinical data management and data analysis functions for the timely completion of high quality publications (i.e. posters, abstracts, study reports) and submissions.
- Ensures that operational performance is in alignment with company strategies and goals.
- Responsible for the design and communication of departmental strategy (e.g. vendor selection and management strategies, departmental structure and growth).
- Interface with senior management regarding trial conduct and related activities.
- Oversight of development and training of new SOPs and updating current SOPs pertaining to managing clinical trials.
- Manage clinical trial budgets and timelines in conjunction with Finance.
- Oversight of all vendors related to the execution of clinical trials
- Responsible for resource planning for the Clinical Operations department.
- Assist in the clinical evaluation of new business opportunities.
- Clinical Operations experience in a biotech or pharmaceutical/CRO/ARO organization with demonstrated proficiency managing clinical programs and teams.
- Experience in execution of oncology clinical trials preferred, including experience in both small Phase 1studies and larger, multi-center trial management.
- Extensive knowledge of FDA regulations and ICH guidelines regarding GCPs.
- Experience selecting and managing CROs.
8 years experience in clinical research. A BS/BA degree in life sciences required, with an advanced degree preferred.
Blend Therapeutics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
Please submit your resume to email@example.com
Blend Therapeutics, Inc., 134 Coolidge Ave., Watertown, MA 02472