Administration & Executive Job In Waltham, Massachusetts
Head of Clinical OperationsNext Steps... Apply Now
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Job ID 2018-1848
# of Openings 1
Category Clinical Ops - Dept
The Sr. Director, Clinical Operations is responsible for leading and driving clinical trial operations for Radius' current and future programs. This role will oversee the Radius Clinical Operations team to ensure all assigned operational trial deliverables across programs are completed according to timelines budget, operational procedures, quality standards, SOPs and business guidelines. This individual will need expertise in successful planning, implementation, and delivery of clinical operations strategy, plans and study execution. The Sr. Director, Clinical Operations will also be responsible for managing and supporting vendor/CRO relationships and activities including negotiations and performance evaluations. This individual will be a member of the R&D leadership team and will be a significant contributor to the overall R&D strategy at Radius.
- Provide functional leadership for clinical operations, including hiring, training, staff assignments, coaching, mentoring and performance management in a matrix environment
- Set department goals and objectives which align with broader company goals
- Provide strategic and tactical input into integrated clinical development strategy and timelines
- Develop clinical operations strategy including risk management and contingency planning
- Build collaborative relationships with key internal stakeholders to facilitate the planning and execution of clinical trials
- Guide the clinical operations execution activities of all clinical trials
- Establish and maintain strategic partnership with Radius CROs and clinical vendors to include vendor governance and identification and resolution of performance issues
- Ensure all clinical trials are executed per key metrics (timelines, budget, operational and quality standards [ICH/GCP/SOPs])
- Maintain procedures to verify the accuracy and timeliness of trial information in all trial databases and tracking systems
- Contribute to global regulatory submissions (FDA, EMA, Health Canada and other governing regulatory bodies)
- Oversee the clinical operations aspects of cross functional work processes involving medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical science
- Drive the creation of clinical operations Standard Operating Procedures (SOPs), systems, and processes
- Foster a highly collaborative culture and serve as a leadership role model within the company and with external stakeholders
- 12 years of clinical operations experience in a pharmaceutical, biotech and/or contract research organization (CRO) setting; including management of a CRO
- 8 years supervisory experience, 5 years direct project/trial management experience and 4 years in leadership role
- Requires a BS in the health or life sciences or equivalent
- Osteoporosis or oncology experience is preferred
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Strong leadership, collaborative and interpersonal skills
- Proven ability to build strong relationships with CROs/vendors
- Excellent computer skills (Microsoft Office Suite, Project, Visio, Electronic Data Capture and Trial Master File Systems)
- Global Clinical Trial Experience and the ability to support more than one clinical trial is preferred
- Experience working independently and in a team environment, being flexible and adapting in a changing environment
- Ability to travel up to 30%
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.