Clinical Development Medical, Associate Director
Scorpion Therapeutics, Phila, Pennsylvania, United States
Role Summary
The primary purpose is to serve as a Clinician within a Pfizer vaccine development program. This role may serve as a clinical lead for one or more studies within a clinical program and works closely with the global clinical program lead who is ultimately responsible for execution of the overall program. This role will be set within a matrix team in executing studies, performing medical monitoring, supporting regulatory interaction, and taking on a leadership role in study teams for many of the clinical deliverables. The clinician is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. Responsibilities
Accountable for safety across the study
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Performs and documents regular review of individual subject safety data, and reviews cumulative safety data with the safety risk lead. The clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP as appropriate. Monitor study safety issues and provide input to serious adverse events (SAEs) reports with medical context. Participates in the Safety Review Team to evaluate medical benefits/risks for targeted clinical indications. Reviews literature to respond to safety questions posed by the Safety Review Team, Data Monitoring Committee (DMC) or others. Communicates safety information to sites across the study and provides responses to questions on safety.
Protocol design and strategy
Contributes to medical input during protocol development and updates to the clinical development plan. Works with other medical monitors to ensure documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and are reviewed by IRB/IECs. Provides medical input into country feasibility.
Support study team
Under supervision of medical monitor provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, and data quality planning. Contributes to CRO/vendor selection to ensure study is conducted in line with protocol requirements and study timelines; ensures medical/technical requirements for data integrity. Works with study team to ensure high quality data and appropriate clinical assessments as the study progresses. Contributes to medical review and interpretation of efficacy and safety data; delivers top-line reports with the statistician and clinical study reports with the medical writer; accountable for quality and timeliness of analysis and reporting. Provides protocol-specific training to study team, investigators, CRAs, and others. Interacts with healthcare professionals at sites to enable quality, compliance and patient safety; interacts with DMCs and steering committees as required. Notifies appropriate study team personnel of changes in research activity and significant new adverse events; monitors investigator compliance with protocol and regulatory requirements. Supports study team in issue resolution, study closeout, audit responses, inspection readiness, etc.
Supports the program team
Under supervision authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, IND sections, clinical study reports). May co-author abstracts, posters, presentations and publications. May contribute to budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators
May support Clinical Regulatory Authority interactions and provide responses. Liaise with Key Opinion Leaders and Principal Investigators to build a network for new trials.
Qualifications
Required:
Medical degree (M.D./D.O. or equivalent). Required:
Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year and has used the license to prescribe in patient care for at least one year. Required:
0–4 years of work experience. Required:
Ability to critically evaluate medical/scientific information. Required:
Excellent written and oral communication. Required:
Understanding of the design, development, and execution of clinical programs and studies. Required:
Capacity to adapt to a fast pace and changing environment. Preferred
Preferred:
Documented work experience/knowledge of statistics. Preferred:
Training and experience in infectious diseases and/or infection control in hospital settings. Preferred:
Experience with investigational clinical trials. Preferred:
No pharmaceutical industry experience required. Preferred:
Leadership experiences and capabilities including influencing and collaborating with peers, developing others, and guiding the work of colleagues to achieve outcomes.
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The primary purpose is to serve as a Clinician within a Pfizer vaccine development program. This role may serve as a clinical lead for one or more studies within a clinical program and works closely with the global clinical program lead who is ultimately responsible for execution of the overall program. This role will be set within a matrix team in executing studies, performing medical monitoring, supporting regulatory interaction, and taking on a leadership role in study teams for many of the clinical deliverables. The clinician is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. Responsibilities
Accountable for safety across the study
Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Performs and documents regular review of individual subject safety data, and reviews cumulative safety data with the safety risk lead. The clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP as appropriate. Monitor study safety issues and provide input to serious adverse events (SAEs) reports with medical context. Participates in the Safety Review Team to evaluate medical benefits/risks for targeted clinical indications. Reviews literature to respond to safety questions posed by the Safety Review Team, Data Monitoring Committee (DMC) or others. Communicates safety information to sites across the study and provides responses to questions on safety.
Protocol design and strategy
Contributes to medical input during protocol development and updates to the clinical development plan. Works with other medical monitors to ensure documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and are reviewed by IRB/IECs. Provides medical input into country feasibility.
Support study team
Under supervision of medical monitor provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, and data quality planning. Contributes to CRO/vendor selection to ensure study is conducted in line with protocol requirements and study timelines; ensures medical/technical requirements for data integrity. Works with study team to ensure high quality data and appropriate clinical assessments as the study progresses. Contributes to medical review and interpretation of efficacy and safety data; delivers top-line reports with the statistician and clinical study reports with the medical writer; accountable for quality and timeliness of analysis and reporting. Provides protocol-specific training to study team, investigators, CRAs, and others. Interacts with healthcare professionals at sites to enable quality, compliance and patient safety; interacts with DMCs and steering committees as required. Notifies appropriate study team personnel of changes in research activity and significant new adverse events; monitors investigator compliance with protocol and regulatory requirements. Supports study team in issue resolution, study closeout, audit responses, inspection readiness, etc.
Supports the program team
Under supervision authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, IND sections, clinical study reports). May co-author abstracts, posters, presentations and publications. May contribute to budget execution of protocols.
Interact with regulatory authorities, key opinion leaders, and principal investigators
May support Clinical Regulatory Authority interactions and provide responses. Liaise with Key Opinion Leaders and Principal Investigators to build a network for new trials.
Qualifications
Required:
Medical degree (M.D./D.O. or equivalent). Required:
Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year and has used the license to prescribe in patient care for at least one year. Required:
0–4 years of work experience. Required:
Ability to critically evaluate medical/scientific information. Required:
Excellent written and oral communication. Required:
Understanding of the design, development, and execution of clinical programs and studies. Required:
Capacity to adapt to a fast pace and changing environment. Preferred
Preferred:
Documented work experience/knowledge of statistics. Preferred:
Training and experience in infectious diseases and/or infection control in hospital settings. Preferred:
Experience with investigational clinical trials. Preferred:
No pharmaceutical industry experience required. Preferred:
Leadership experiences and capabilities including influencing and collaborating with peers, developing others, and guiding the work of colleagues to achieve outcomes.
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