VP/SVP of Clinical Operations
VP/SVP of Clinical Operations
Skyhawk Therapeutics seeks a knowledgeable, experienced, and motivated individual to join our team and lead clinical operations. Reporting to the SVP of Clinical Development, this individual will be responsible for developing the strategy for the clinical operations department build, for implementing best-in-class and efficient clinical trial processes, and for initiating and managing the conduct of the company’s clinical program.
Responsibilities:
- Lead all clinical operation activities for several programs
- Oversee a highly efficient clinical operations group
- Develop and implement the strategy for clinical operations, including organizational structure and execution
- Oversee CROs to avoid issues and/or rapidly adapt to challenges of feasibility/start up, slow recruitment, resourcing, site management, etc.
- Collaborate with R&D leadership, clinical, regulatory, non-clinical, CMC, finance, legal, patient advocacy, and QA to build an integrated development plan that meets corporate goals
- Monitor study-specific timelines, key deliverables, and implement strategies to optimize the efficiency of trial conduct
- Review and approve as required, study documentation for clinical programs including monitoring plans, informed consent forms, case report forms, investigator agreements and financial agreements
- Responsible for clinical operations SOPs and quality management systems to standardize and support global adherence to company policies and procedures, cGCP and related regulatory processes
- Support data analyses and communication of clinical research results in accordance with applicable regulations, and in support of strategic business and/or regulatory goals
Requirements, Education, Experience & Skills:
- BA/BS/MS and 15+ years directly related experience in clinical operations and trial management.
- Strong expertise in conducting global pivotal studies, full phase life cycle experience required
- Experience working in neurology and/or rare diseases clinical development is desired
- In-depth knowledge and understanding of all aspects of clinical operations management, with a track record of successfully managing programs to completion on time and on budget
- Demonstrates a proactive, hands-on approach to addressing challenges and is willing to be actively involved in all aspects of clinical operations.
- Experience managing a clinical operation team
- Experience working in a fast-paced biotech environment and adapt to changing priorities
- Experience interacting and managing with regulatory and ethics authority submissions
- Experience with regulatory audits and inspections
- In-depth understanding of GCP regulations and knowledge of other regulatory guidelines (GLP and GMP)
- Understanding of IND & NDA/BLA regulations
- Proven experience in managing & directing related functions such as data management & operations, CRO vendor management including diagnostic vendors, procurement & contracting etc.
- Proven track record of leadership and operational excellence required
- Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment
- Excellent communications skills and ability to influence across multiple functions
About Skyhawk
Skyhawk is committed to discovering, developing, and commercializing small molecule therapeutics that correct RNA splicing. We use our novel SkySTAR® platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed to targets for some of the world’s most intractable diseases including cancer, neurological conditions, and other “undruggable” targets against a wide range of conditions.
Create a Job Alert
Interested in building your career at Skyhawk Therapeutics? Get future opportunities sent straight to your email.
Apply for this job
*
indicates a required field