Rapt
PURPOSE OF JOB
The Senior Medical Director reports to the VP of Clinical Development and is responsible for the execution and reporting of Phase II/III clinical studies, with an initial focus on the clinical development of RPT904 in food allergy and chronic spontaneous urticaria. This physician scientist will provide clinical and drug development expertise and will work closely with cross-functional teams to align the clinical development plan with the overall development strategy of the program. MAJOR DUTIES AND RESPONSIBILITIES
Clinical Development Lead for Phase II and III clinical trials, eg: Provide clinical development functional input through all aspects of clinical trial conduct including start-up through database lock and CSR finalization Serve as the Sponsor Medical Monitor for clinical trials Review real-time and aggregate safety data for routine medical data review, trend review, and safety signals from ongoing trials Review serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with the CRO to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs Provide monitoring of ongoing clinical trial data, including blinded efficacy data Participate in interpretation of data analyses of clinical trial results and developing clinical trial reports Participate in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources Lead study specific committees (eg DMC, adjudication) with operational support Answer medical queries raised by EC/IRBs Support Clinical Development program in inflammatory disease, eg: Provide strategic and design input for clinical trials and clinical development plans Participate in/and or lead preparation, design, and/or review of clinical documents, e.g. protocols, investigators brochures, DSUR Contribute to clinical sections of relevant regulatory filings (IND, study reports, NDA, PIP, briefing packages, etc.) Represent the company at scientific meetings and presentations Contribute to scientific affairs by contributing to the publication plan and authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards) Develop and manage relationships with key opinion leaders for clinical programs EDUCATION REQUIREMENTS
M.D. or M.D./Ph.D., with board certification in Allergy and Immunology or Dermatology or related field required EXPERIENCE REQUIREMENTS
Minimum of 6 years late stage (Phase II/III/IV) global clinical trial experience in pharmaceutical or biotech industries preferred, or equivalent academic and clinical experience Minimum of 2 years experience in clinical development in the field of Allergy/Immunology Minimum of 2 years experience managerial experience Experience with successful Health Authority (eg FDA, EMA, PMDA) interactions (eg NDA, EOP2, Scientific Advice) Be well connected within the medical and scientific community and have a proven successful track record Hands-on experience with clinical trial strategy, methods and designs Ability to work proactively and effectively, with exceptional creative problem-solving skills Excellent strategic planning, organizational and communication skills Up to 20% travel
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The Senior Medical Director reports to the VP of Clinical Development and is responsible for the execution and reporting of Phase II/III clinical studies, with an initial focus on the clinical development of RPT904 in food allergy and chronic spontaneous urticaria. This physician scientist will provide clinical and drug development expertise and will work closely with cross-functional teams to align the clinical development plan with the overall development strategy of the program. MAJOR DUTIES AND RESPONSIBILITIES
Clinical Development Lead for Phase II and III clinical trials, eg: Provide clinical development functional input through all aspects of clinical trial conduct including start-up through database lock and CSR finalization Serve as the Sponsor Medical Monitor for clinical trials Review real-time and aggregate safety data for routine medical data review, trend review, and safety signals from ongoing trials Review serious adverse event (SAE) reports from ongoing clinical studies and work in close collaboration with the CRO to review causality and develop MedWatch/CIOMS reports (including narratives and analyses of similar events) for reportable SAEs Provide monitoring of ongoing clinical trial data, including blinded efficacy data Participate in interpretation of data analyses of clinical trial results and developing clinical trial reports Participate in site/investigator identification and evaluation for clinical trials; conduct site initiation and engagement calls and visits Serve as program medical expert for internal and external collaborators, investigators, consultants, and contract resources Lead study specific committees (eg DMC, adjudication) with operational support Answer medical queries raised by EC/IRBs Support Clinical Development program in inflammatory disease, eg: Provide strategic and design input for clinical trials and clinical development plans Participate in/and or lead preparation, design, and/or review of clinical documents, e.g. protocols, investigators brochures, DSUR Contribute to clinical sections of relevant regulatory filings (IND, study reports, NDA, PIP, briefing packages, etc.) Represent the company at scientific meetings and presentations Contribute to scientific affairs by contributing to the publication plan and authoring and / or reviewing abstracts, presentations and manuscripts for medical accuracy and content Attend and provide medical support for investigator and consultant meetings (e.g., investigator meetings, clinical advisory boards) Develop and manage relationships with key opinion leaders for clinical programs EDUCATION REQUIREMENTS
M.D. or M.D./Ph.D., with board certification in Allergy and Immunology or Dermatology or related field required EXPERIENCE REQUIREMENTS
Minimum of 6 years late stage (Phase II/III/IV) global clinical trial experience in pharmaceutical or biotech industries preferred, or equivalent academic and clinical experience Minimum of 2 years experience in clinical development in the field of Allergy/Immunology Minimum of 2 years experience managerial experience Experience with successful Health Authority (eg FDA, EMA, PMDA) interactions (eg NDA, EOP2, Scientific Advice) Be well connected within the medical and scientific community and have a proven successful track record Hands-on experience with clinical trial strategy, methods and designs Ability to work proactively and effectively, with exceptional creative problem-solving skills Excellent strategic planning, organizational and communication skills Up to 20% travel
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