Tel. +381 11 314 97 25
IL - Deerfield
704 - Clinical Operations
13. decembar 2013
Supports the development of efficacy and safety data on Lundbeck Inc drugs and compounds. Responsible for the strategic design and management of a project and will assist with the development, direction, and execution of clinical programs for all Lundbeck products. Primary manager of a complex multicenter, multinational phase 2-4 study or manage the execution of more than one phase 2-4 study, depending on the complexity of the trial. Primary manager for tasks related to IND or NDA document preparations and preparation of integrated summary reports for NDA applications. Capable of leading study specific project teams. Assists in the integration of key components of the clinical development plan (CDP).
• Performs all functions with minimal supervision while independently assuming responsibility for project management / execution of clinical studies (phases 1-3), including project timelines, resources, and budgets. Manages CRAs for inhouse studies and CTAs who perform in-house monitoring functions for clinical studies. Assumes primary responsibility for the management of multicenter phase 3 studies including studies with multi-national sites and more complex CRO/vendor support structures.
• Conceptualize, plan, design, place, execute, and summarize clinical studies.
• Assist with program planning, including development of timelines, resources, and budgets and facilitate plan. Assist with the management of clinical programs, including personnel management and development, mentoring of clinical personnel, and effective delegation of assignments. Coordinate with all functional groups (finance, safety, marketing, legal, and manufacturing) to identify, assess, and solve problems in order to assure program progress and timely completion of program goals.
• Determines the outsourcing strategy for a clinical program and assists the Associate Director in developing budgets for outsourced tasks.
• Effectively communicate (oral and/or written) project-related information including the planning and execution of meetings and presentations and work with Clinical Operations to develop program plans including timelines, resources, and budgets and facilitate plan.
• Finalize specifications, payment structure and milestones for clinical contracts with CROs. Negotiates site budgets.
• Assist senior management in clinical SOP development and periodically reviews SOPs. Contributes to document preparation for IND submissions and assists in the development, review and completion of integrated summary documents for NDA submissions and issue RGL for clinical studies.
• Interacts effectively with project teams and cross functionally on a regional and global scale to influence overall project course and success
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
• Bachelor's Degree, preferably in Life Science or related field.
• 7+ years experience in progressively responsible positions in clinical departments conducting clinical studies.
PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
• Advanced Degree (e.g., MS, Ph.D. or Pharm D)
• 7+ years experience in progressively responsible positions in clinical departments conducting clinical studies including project management experience in a pharmaceutical, biotech or CRO industry or 3+ years in a pharmaceutical, biotech or CRO industry and 4+ years in an academic, clinic or private setting.
• 5+ years experience in planning & executing pharma-sponsored phase 1 through phase 3 clinical research studies intended for use in IND and NDA applications to FDA; timeline and budget development for clinical study programs
including phase 2 and 3 clinical studies, including outsourced work.
• 4+ years experience in planning & executing pharma-sponsored clinical research studies intended for use in IND and NDA applications to FDA.
• 3+ year of experience in timeline and budget development for clinical study programs including phase 2 and 3 clinical studies, including outsourced work.
• Experience in effectively training and/or mentoring clinical employees and site personnel in clinical studies and safety review of clinical data plus the ability to manage internal/external (CRO/contract) personnel in clinical study conduct.
• Experience contributing to the development of documents for IND or NDA applications to the FDA, including integrated summary reports; experience preparing and conducting a variety of presentation types including management updates, investigator meetings and project team updates; experience planning and executing small-to-large scale clinical studies, including applicable budgets; experience managing Pharma-Sponsored clinical research studies intended for use in NDA applications to FDA; experience in a variety of therapeutic areas.
• Versed in GCP, ICH and CFR regulations with a history of preparing successful NDA application(s) to FDA with the ability to maintain highest standards for regulatory compliance at all times.
Willingness/Ability to travel up to 10% domestically. International travel is required.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.