Cure SMA is seeking an Operations Director to oversee the strategic and operational management, execution, and delivery of the Cure SMA Clinical Care programs. S/he will be responsible for setting project scope, timelines, and budget, and ensuring that stakeholders adhere to those objectives.
Reporting to the Medical Director, the Operations Director will work closely with the entire Clinical Care team to facilitate the implementation of all projects. External relationships may include software vendor companies, care centers and organizations, legal experts, industry consultants, biopharma companies, and academic centers.
Cure SMA leads the way to a world without spinal muscular atrophy, the number one genetic cause of death for infants. We fund and direct comprehensive research that drives breakthroughs in treatment and care, and we provide families the support they need for today.
Work with the Clinical Care team to set strategic goals for the department programs and translates those goals into specific operational objectives
Collaborate with all relevant stakeholders and provide support in the evaluation of external organizations, including software vendors, healthcare organizations, and federal agencies
Projects in the Clinical Care department include:
Development and support of Cure SMA Care Centers
Development of clinician entered patient database registry to support the Cure SMA Care Centers
Guiding processes for clinical care advancement
Advancing medical professional education and increasing the clinician network
Advancing patient and parent clinical care education
Driving and supporting activities of the Medical Advisory Council (MAC)
Determine resources needed to achieve operational objectives including personnel, funding, etc.
Assess long-range resource needs and makes recommendations and allocations across projects
Work with the Development department to secure funding sources for Clinical Care programs
Accountable for providing oversight to the Clinical Care Program Manager and their projects
Provides direction on strategic and operational issues in support of these projects
Oversee and drive the outsourcing and partnership efforts for clinical care program implementations
Develop policies and procedures for executing the operational objectives
Resolves and/or escalates issues raised by assigned staff
Uses in-depth knowledge of regulatory/industry guidelines, e.g., HIPAA, MACRA, etc. to drive the developmet of Cure SMA Care Centers and the clinical data registry (CDR) process
Mentors and coaches staff
Interviewing, hiring, and training employees
Planning, assigning, and directing work
Setting objectives, appraising performance, and rewarding and disciplining employees
Addressing complaints and resolving problems
Develops and reviews strategy for operational efficiency
Assess activities related to the Cure SMA Care Centers and CDR and track key performance indicators
Remedy processes that do not meet expectations
Establishes/identifies innovative initiatives targeted to revise and improve clinical care processes locally and nationally
Represent program overview/status to senior management, and external partners as necessary
Minimum skills/experience required
Bachelor’s degree is required. Business or healthcare field preferred, but not required. Advanced degree preferred
Minimum of 5 years of clinical research and organizational management within the pharmaceutical / biotech industry, a CRO or similar organization
Demonstrated success in program implementation and process improvement
Previous direct management of team members required
Strong background in project management and interpersonal skills
Detailed knowledge of current regulatory requirements and guidelines governing clinical research and/or registries
Able to prioritize, schedule, and monitor multiple projects
Able to establish strong collaborative relationships and work with others in a cooperative and effective manner
Advance interpersonal skills and a demonstrated ability to manage conflict
Able to strategically work cross-functionally with a variety of stakeholders
Excellent written and verbal communication skills
Demonstrated ability to present complex information to management, vendors, and external audiences
Strong attention to detail
Ability to establish priorities for team
Ability to work independently, take initiative, complete tasks to deadlines and support assigned staff in doing the same.
Demonstrated ability to lead, motivate, and mentor staff and team
Previous experience with electronic medical records and/or data registries preferred
Technical proficiency in with the complete Microsoft Office suite required
Project Management Professional preferred, but not required
Cure SMA is a 501 (c)(3) organization dedicated to the treatment and cure of spinal muscular atrophy (SMA), a disease that takes away a person's ability to walk, eat, or breathe. It is the number one genetic cause of death for infants.
Cure SMA is committed to the principle of equal employment opportunity. Applicants for employment and employees are reviewed on their individual qualifications ...for a position. Under no circumstances will Cure SMA discriminate against qualified persons on the basis of race, color, religious creed, retaliation, national origin, ancestry, sexual orientation, gender, gender identity/expression, disability, mental illness, genetics, choice of health insurance, marital status, age, veteran status, or any other basis prohibited under applicable law.