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Medical Director & Clinical Research San Diego United States,  


Posted on : 19 June 2017

Project Description

Major responsibilities include: " Medical oversight for ongoing clinical trials throughout conduct and support all medical and scientific aspects of clinical trial (s) and program level activities as assigned, including interpretation of results, clinical study reports and graphical displays. " Ensure appropriate scientific rigor in the design, conduct, validity and interpretation of clinical trial to support regulatory applications or business/marketing objectives. " Contribute to the strategic planning, authoring, and review of regulatory documents, scientific data disclosures, and commercial support documents. " Conduct and have oversight over Intercept medical monitoring activities and co-lead interactions with the Data Safety Monitoring Committee. " Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate. " Provide medical expertise and support to externally facing groups/stakeholders, including the field medical team, medical information and the commercial organization. " Maintain close collaboration and cooperation with clinical operations on the implementation and execution of clinical studies. " Contribute and be responsible to the development planning, authoring and review of manuscripts and other scientific data disclosures. " Contribute to departmental resource planning, budgeting and timeline setting to meet company needs. " Provide oversight and coaching to more junior clinical research personnel. Key Activities & Responsibilities: " Contribute to/lead the strategic planning and execution of clinical development plans " Provide medical input during the development and execution of clinical trials including protocol development through the review and interpretation of trial results and finalization of the clinical study report " Medical support and/or authoring of clinical and regulatory documents including NDA/MAA, DSUR, briefing documents, regulatory responses, investigator brochure; Participate in regulatory interactions " Provide medical support to lifecycle management activities as directed by Development Lead " Provide medical support cross-functional collaborations to integrate broad medical, scientific, and commercial input into the medical affairs strategy and development program " Provide scientific/medical expertise and support to externally facing groups, including the field medical team, medical information, business development and the commercial organization " Contribute to the strategic planning, authoring, and review of medical and commercial support documents and initiatives including manuscripts, abstracts, posters, FAQs, standard response letters and promotional material " Serve as a medical interface to key opinion leaders (KOL), facilitating KOL advocacy development " Provide oversight and coaching to more junior clinical research personnel " Maintain close collaboration and cooperation with clinical operations on the implementation and execution of clinical studies. " Identify significant issues that may impact overall project plans and initiate contingency plans as appropriate " Other duties as assigned. Required Experience: " MD degree with a minimum of 3 years or more direct biotechnology or pharmaceutical industry experience in Clinical Research " Prior experience in Hepatology, Gastroenterology, or related field, preferred. " Prior industry experience as a medical monitor contributing to the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents. Prior industry experience in interactions and support of Medical Affairs and Commercial groups and activities. REQUIRED KNOWLEDGE AND ABILITIES: " Knowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements. " Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication. " Demonstrated ability as a medical expert in a complex matrix environment. " Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment. " Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously. " General familiarity with biostatistics; expert in navigating scientific literature, interpretation of data, display of data. " Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures. " Highly proficient in standard computer software (Word, Excel and Power Point). " Ability to travel, in some cases, internationally. (Average travel expectations: 20%/year).

Locations

San Diego CA United States

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