Senior Director, Clinical Research
SUMMARY OF POSITION
This newly created position will reports to the Chief Medical Officer and will be responsible for managing the clinical, scientific, administrative, and technical activities for the clinical research team. Responsibilities include oversight of the strategy, planning, conduct, and analysis of data from clinical studies, with emphasis on overall clinical study leadership within the Rare Disease space, in line with departmental and corporate goals. This person also ensures quality, timely and coordinated clinical study activities and ensures compliance with the appropriate GCP/ICH and health authority guidelines. This individual provides clinical development expertise on behalf of the company and represents the company at appropriate academic, industry, medical and regulatory meetings.
MAJOR ACTIVITIES AND RESPONSIBILITIES Reporting to the Chief Medical Officer, the Senior Director Clinical Research will;
• Provide leadership to the Clinical Research team involved in the execution of all clinical studies. Responsible for the strategic planning, design, conduct, analysis, and reporting of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for approval of products.
• Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, and clinical expert reports.
• Proactively communicates with internal colleagues, and collaborates with peers in other functional areas, and develops and maintains effective relationships with KOLs, medical experts and consultants.
• Represents the company at academic, medical, industry and regulatory meetings.
• Provides guidance on potential business development opportunities
• Provides both day to day management of the members of the Clinical Research team as well as developing their career paths.
• Develops and administers budgets, resource plans and performance objectives for his/her team and area.ORGANIZATIONAL STRUCTURE
The Vice President, Clinical Research reports to the Chief Medical Officer.
QUALIFICATIONS AND BACKGROUND REQUIREMENTS Educational Requirements
• An advanced degree in a relevant field (MD) with experience / knowledge in rare disease clinical research and development preferred. 10 – 12 + years clinical drug development process experience preferred with academic experience as well.
Professional Work Experience
• Knowledge of GCP/ICH guidelines and best practices in Clinical Research and Development. Rare disease experiences preferred.
• Excellent managerial and leadership skills.
• Excellent verbal communication skills to effectively represent the company at a corporate level, with internal working groups/project teams and external academic/industrial/regulatory organizations.
• Excellent written skills. • Team player, possesses sense of urgency, and exhibits potential for mentoring others.
• Must have planning skills to schedule activities to meet Clinical Research and Development and project team deadlines.
• Possess problem solving ability, and skills to address medical, clinical study and technical questions in a multi-disciplinary environment.
• Must keep abreast of medical and scientific literature within the rare disease area. • Must maintain high ethical standards and integrity at all times.
• Strong leadership skills with an ability to set a vision, to lead change, and to lead and mentor others
• Ability to create and communicate a compelling sense of core purpose and ability to solicit opportunities and possibilities
• Ability to organize, structure and staff the organization in a rapidly changing environment • Strong personal presence with ability to command respect through exercise of sound business
judgment and clear decision-making
• Forward thinker with strong industry knowledge and an ability to identify, synthesize and act upon strategic information and changes within the environment
• Demonstrates a passion for and focus on results with an ability to create excitement and a sense of purpose.
• Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing.
• Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.
• Excellent management skills–hiring, recruiting, training, performance management, planning, prioritization, objective setting, meeting management and plan execution.
• Demonstrated decision-making and problem solving capability