Director Regulatory Operations

Profile

OverviewnRadius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine and other therapeutics. Radiusu2019 lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; an investigational abaloparatide transdermal system for potential use in the treatment of postmenopausal women with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases, initially targeting Prader-Willi syndrome.nThe Director Regulatory Operations provides project leadership to cross-functional teams in the successful delivery of all phase drug development projects or sub-projects. These responsibilities include leadership of the team in predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making on projects. The incumbent has a high level of interaction with Senior Management to ensure that the scientific strategy is clearly integrated into operational plans.nResponsibilitiesnEssential Responsibilities:nn Leads the project planning efforts for assigned development programs in defining and implementing the project strategy and operational plan by managing the creation of the operational plan and formulating the project scope, project plan, & critical paths with the Project Team and Senior Management team.n Identifies and drives project and resource priorities that align with the business objectives that establishes, communicates and executes plans that drive toward goal achievement.n Provides clear direction and obtains buy-in of all team members to integrated global development plan commitments.n Develops strong logistical skills to manage activities across functions and regions.n Manages the identification and escalation of potential issues/risks or obstacles and achieves resolution or plans contingencies and follows issues through to resolution ensuring that all issues arrive at a singular conclusion or recommendation.n Leads and manages a drug development budget of varying size and scope in all phases of drug development projects.n Generates collaboration, cooperation, and communication across functions to achieve stated goals.n Sets and manages expectations, highlighting and resolving issues, ensuring regular communications, and managing internal and external activities. n Participates in the annual portfolio analysis process to ensure accurate information and timelines are completed to support project recommendations to Senior Management.n Works with Regulatory Affairs to effectively manage timely completion of clinical trial applications and end of Phase II and Phase III meetings.n Manage and mentor junior staff in both regulatory operations and project management.n Assume role of business owner for regulatory and R&D systems and applications.n Works with business development to manage R&D documentation and interacts with external business partners.n Provides regulatory guidance regarding health authority submissions and technical requirements.n Manages vendors across multiple projects. Sets expectations and verifies the quality of work being produced. n Develops or improves workflow processes for both regulatory and R&D.n Annually reviews standard operating procedures and updates as needed. nnQualificationsn Experience and Qualifications:nn Bacheloru2019s degree or equivalent in Science or Mathematics is required, with a masteru2019s degree preferred.n 8-12 years of directly related experience.n Strong collaboration skills.n Ability to lead and manage team members and cross-functional groups.nn nWork Environment:nThe 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.  Occasional travel required.n nThe 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.n nWhile 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.  n nSpecific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.n nEqual Opportunity Employer Statement:n**MEMBERS ONLY**SIGN UP NOW***. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, **MEMBERS ONLY**SIGN UP NOW***. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.n n n n n n n nPM18

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