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MANAGER, MEDICAL AFFAIRS
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>Currently, one of our top clients is in search of an exceptional Manager, Medical Affairs in South San Francisco, CA. The purpose of the Manager, Medical Affairs is to maximize the value of a molecule by supporting the development of Patient-Reported Outcome (PRO) strategies during early clinical development and to implement those strategies. The inclusion of PRO measures in trials is critical for creating robust and differentiated product profiles and for providing information important for therapeutic decision-making to patients, physicians and payers.Specific accountabilities:* Work cross-functionally with Global Development, Global Product Strategy, International Business Teams, Global Health Economics and Affiliates to implement PRO strategies* Ensure relevant PRO endpoints and study design for registration clinical trial programs meet the needs of global regulatory agencies and key stakeholders* Assist in identifying PRO instruments and evaluate measurement and psychometric properties of the instruments* Work with external key opinion leaders to obtain guidance on PRO implementation* Contribute to the design, implementation, and management of registration clinical trials containing PROs including the development of the PRO sections of study concept documents, study protocols, statistical analysis plans, clinical study reports and other development documents* Support the development and/or validation of instruments for PRO as needed* Adapt and validate instruments for use in different patient populations, including cultural adaptations and translations* Work with Global Scientific Communications to execute a publication plan that is integrated with overall publication strategy to communicate PRO information to physicians, patients, payers, and policy makers* Responsible for Vendor management including scope of work development, contract initiation, and project milestones, timelines, deliverables, and budgets
</tr>
<tr><td valign="top" width="450"><b>Currently, one of our top clients is in search of an exceptional Manager, Medical Affairs in South San Francisco, CA. The purpose of the Manager, Medical Affairs is to maximize the value of a molecule by supporting the development of Patient-Reported Outcome (PRO) strategies during early clinical development and to implement those strategies. The inclusion of PRO measures in trials is critical for creating robust and differentiated product profiles and for providing information important for therapeutic decision-making to patients, physicians and payers.Specific accountabilities:* Work cross-functionally with Global Development, Global Product Strategy, International Business Teams, Global Health Economics and Affiliates to implement PRO strategies* Ensure relevant PRO endpoints and study design for registration clinical trial programs meet the needs of global regulatory agencies and key stakeholders* Assist in identifying PRO instruments and evaluate measurement and psychometric properties of the instruments* Work with external key opinion leaders to obtain guidance on PRO implementation* Contribute to the design, implementation, and management of registration clinical trials containing PROs including the development of the PRO sections of study concept documents, study protocols, statistical analysis plans, clinical study reports and other development documents* Support the development and/or validation of instruments for PRO as needed* Adapt and validate instruments for use in different patient populations, including cultural adaptations and translations* Work with Global Scientific Communications to execute a publication plan that is integrated with overall publication strategy to communicate PRO information to physicians, patients, payers, and policy makers* Responsible for Vendor management including scope of work development, contract initiation, and project milestones, timelines, deliverables, and budgets
KEY REQUIREMENTS:
Not stated
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