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MEDICAL DIRECTOR (MD), CLINICAL SCIENCE
Job Field: Environmental Jobs
Location: South San Francisco, CA
Salary: $Not stated
Location: South San Francisco, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Medical Director (MD), Clinical ScienceClinical Science | South San Francisco, CA, United StatesSummary:Responsible for the execution of clinical trials phases 1 through 4, for purposes of preparation and filing of original NDAs, pediatric indication, extension of exclusivity, and safety of novel and marketed agents.Essential/Primary Duties, Functions and Responsibilities:* Report to the Group Medical Director or Sr Medical Director* Medical monitor accountable for phase I-4 trials* Review and interpret clinical efficacy and safety data from development programs and the literature* Partners with drug safety to ensure adequate safety evaluation of the molecule across the program* Develop clinical development strategy (lead or participant)for PDP* Clinical member of cross functional team (e.g. PDT)* May be the lead contact on an assigned clinical development project* Participates in the development of manuscripts and abstracts* Represents the department on publication planning* Other Duties as assigned.RequirementsWork Experience:Minimum of 3 – 5 years clinical development experience in the pharmaceutical or biotechnology industry.Management of Staff:Responsible for up to 1 – 3 direct reports (Clinical Scientists and Associate Medical Directors, including an administrative team member).Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):* Must be fully knowledgeable and skilled in the development and implementation of a clinical plan• Protocol design and writing• Study team management• Data review and interpretation* Management of project deliverables such as clinical development plans, data listings reviews, advisory board preparation* Must be able to participate in FDA interactions• IND• NDA/sNDA• IB* Other regulatory submissionsEducation/Training:* MD or DO requiredLicense/Certification Required:* MD or DO requiredOther Requirements (list any other requirements not identified above, for example, ability to prioritize multiple tasks, ability to work under pressure, ability to work with others, oral or written communication skills, travel requirements, and the like):* Highly advanced oral, writing and presentations skills* Communicates externally with scientific congresses and advisory boards<<
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<tr><td valign="top" width="450"><b>Medical Director (MD), Clinical ScienceClinical Science | South San Francisco, CA, United StatesSummary:Responsible for the execution of clinical trials phases 1 through 4, for purposes of preparation and filing of original NDAs, pediatric indication, extension of exclusivity, and safety of novel and marketed agents.Essential/Primary Duties, Functions and Responsibilities:* Report to the Group Medical Director or Sr Medical Director* Medical monitor accountable for phase I-4 trials* Review and interpret clinical efficacy and safety data from development programs and the literature* Partners with drug safety to ensure adequate safety evaluation of the molecule across the program* Develop clinical development strategy (lead or participant)for PDP* Clinical member of cross functional team (e.g. PDT)* May be the lead contact on an assigned clinical development project* Participates in the development of manuscripts and abstracts* Represents the department on publication planning* Other Duties as assigned.RequirementsWork Experience:Minimum of 3 – 5 years clinical development experience in the pharmaceutical or biotechnology industry.Management of Staff:Responsible for up to 1 – 3 direct reports (Clinical Scientists and Associate Medical Directors, including an administrative team member).Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):* Must be fully knowledgeable and skilled in the development and implementation of a clinical plan• Protocol design and writing• Study team management• Data review and interpretation* Management of project deliverables such as clinical development plans, data listings reviews, advisory board preparation* Must be able to participate in FDA interactions• IND• NDA/sNDA• IB* Other regulatory submissionsEducation/Training:* MD or DO requiredLicense/Certification Required:* MD or DO requiredOther Requirements (list any other requirements not identified above, for example, ability to prioritize multiple tasks, ability to work under pressure, ability to work with others, oral or written communication skills, travel requirements, and the like):* Highly advanced oral, writing and presentations skills* Communicates externally with scientific congresses and advisory boards<<
KEY REQUIREMENTS:
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