Trius Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of antibiotics for severe or life-threatening infections. Trius is committed to developing innovative therapeutics, cutting-edge technologies, and pursuing the highest quality science - a commitment which is reflected in our employees.
The Medical Director serves as Medical Monitor for Clinical Trials, ensuring compliance with GCP regulations and monitoring the conduct of clinical trials and safety of enrolled subjects. Generally works on multiple trials or more than one program at a time comprised primarily of Phase II or Phase III global trials in the area of Infectious Disease. Depending on experience level, the Medical Director could potentially oversee development strategy for any one of our compounds. This individual will align with the broader strategy and needs of other Infectious Disease related projects and coordinate with the clinical studies to be carried out in support of the development plan for this compound(s).
Act as the Medical Monitor for clinical trials
Develop the clinical protocols, investigators brochures and clinical development plans (in coordination with the Clinical Program Manager) with emphasis on scientific and safety matters, with minimal guidance
Represents Trius Therapeutics to investigators outside medical/scientific experts in the development of the clinical protocols, solicitation of input and opinion, and presents at conferences and symposiums. Support the development of key scientific external relationships with opinion leaders
Utilizes novel and creative methods to resolve clinical development problems independently
Acts as liaison between clinical development department and cross function teams
Interface with US and international regulatory authorities. Contribute to the production of regulatory documents such as IND and NDA filings, IND annual reports and other regulatory submissions required by global regulations
Oversee all aspects related to the scientific and medical risks in collaboration with the safety function
Lead the review, analysis and interpretation of study data
Maintain knowledge with progress in the field
Other responsibilities could include:
Act as the international clinical lead for the compound both internally and externally with global regional monitors
Oversee the writing of protocols, the conduct of trials and the analyses of data for this compound
Interface with international regulatory authorities, as appropriate, in support of the development objectives for the compound and assist Regulatory Strategy staff in the compilation of submissions and in the response to inquiries
Ensures compliance with Trius SOP's, ICH, GCP and other national and international regulatory requirements
Ensure alignment of development strategy for a compound(s) with other projects within the therapeutic franchise area
MD; sub-specialty training in internal medicine, critical care or infectious disease. Board certified or equivalent
3+ years of basic or clinical research experience in an academic setting with publications in peer reviewed journals
Sound scientific and clinical judgment and the ability to present ideas and document complex medical/clinical concepts in both written and oral communication. Experience with presentations to external parties (posters, paper, seminars)
Ability to work collaboratively in a team-based matrix management environment with minimal supervision
Ability to communicate effectively in English
Legally authorized to work in the US
Candidate must be creative, flexible, team-oriented and have passion and an energy level commensurate with a fast-paced, small company, multinational environment
3+ years of basic or clinical research experience in an academic setting with publications in peer reviewed journals and 3+ years of experience in clinical development within the pharmaceutical/biotechnology industry
Experience in filing and defending US NDA's or similar ex-US regulatory submissions
Trius is proud to be an Equal Opportunity Employer with a commitment to Affirmative Action for Minorities, Women, Individuals with Disabilities and Veterans.
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