Clinical Development Lead, Neuropsychiatry (Senior Director)
Scorpion Therapeutics, Brisbane, California, United States, 94005
Role Summary
Clinical Development Lead, Neuropsychiatry (Senior Director) sits in Clinical Development, a global function responsible for designing, executing, and interpreting drug development programs for assets in neuropsychiatry. The role acts as a matrix leader, accountable for the overall clinical development plan for asset(s) across one or more indications, and ensures studies align with target label indications to meet regulatory, quality, medical, and access goals. It requires leading and developing clinical teams, partnering with Clinical Trial Physicians, Clinical Scientists, KOLs, and Worldwide Patient Safety, and representing Clinical Development in internal and external forums. Travel may be required domestically and internationally. Responsibilities
Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians May serve as CTP as necessary Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function Partners with Worldwide Patient Safety physicians in the ongoing review of safety data Serves as the (co-)leader of the cross-functional Clinical Development Team Provides clinical leadership and disease area expertise into integrated disease area strategies Partners closely with KOLs in specific indications Serves as Primary Clinical Representative in Regulatory interactions Evaluates strategic options against a given Target Product Profile (TPP) Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed Sets executional priorities and partners with CTP and CS to support executional delivery of studies Accountable for top line data with support of CTP, CS, and Statisticians Qualifications
At least 10 years of relevant experience Experience Requirements: CDL Has Demonstrated Leadership In The Design And Execution Of Multiple Clinical Trials (e.g. Significant Experience As a Senior Clinical Leader), And Exhibits All Of The Following Attributes Able to synthesize internal and external data to produce a clinical strategy Able to ensure that the clinical program will result in a viable registrational strategy Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues) Skills
CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s) External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials) Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables Education
MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge Additional Requirements
Domestic and International travel may be required.
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Clinical Development Lead, Neuropsychiatry (Senior Director) sits in Clinical Development, a global function responsible for designing, executing, and interpreting drug development programs for assets in neuropsychiatry. The role acts as a matrix leader, accountable for the overall clinical development plan for asset(s) across one or more indications, and ensures studies align with target label indications to meet regulatory, quality, medical, and access goals. It requires leading and developing clinical teams, partnering with Clinical Trial Physicians, Clinical Scientists, KOLs, and Worldwide Patient Safety, and representing Clinical Development in internal and external forums. Travel may be required domestically and internationally. Responsibilities
Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication Responsible for managing clinical trial physician(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of clinical trial physicians May serve as CTP as necessary Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function Partners with Worldwide Patient Safety physicians in the ongoing review of safety data Serves as the (co-)leader of the cross-functional Clinical Development Team Provides clinical leadership and disease area expertise into integrated disease area strategies Partners closely with KOLs in specific indications Serves as Primary Clinical Representative in Regulatory interactions Evaluates strategic options against a given Target Product Profile (TPP) Collaborates with Global Development Operations/Global Compliance Group to develop asset level risk management plan, resolves issues with Quality/CS, and raises to DT as needed Sets executional priorities and partners with CTP and CS to support executional delivery of studies Accountable for top line data with support of CTP, CS, and Statisticians Qualifications
At least 10 years of relevant experience Experience Requirements: CDL Has Demonstrated Leadership In The Design And Execution Of Multiple Clinical Trials (e.g. Significant Experience As a Senior Clinical Leader), And Exhibits All Of The Following Attributes Able to synthesize internal and external data to produce a clinical strategy Able to ensure that the clinical program will result in a viable registrational strategy Able to assess personnel needs, translate into a hiring strategy, and lead the hiring efforts Able to work with other stakeholders to ensure a robust enterprise level strategy for asset(s) and indication(s) including early, late and post-marketing development, as well as awareness of the enterprise disease area portfolio CDL has demonstrated, sustained excellent performance as Clinical Trial Physician, Clinical Scientist, or equivalent Verifiable track record of successful people management and development, or leadership in a matrix team (e.g. mentoring junior colleagues) Skills
CDL has demonstrated excellent skills in clinical development strategy including the clinical components of regulatory submission(s) External focus to understand the trends in the disease area treatment paradigms and ability to build relationships with external partners, thought leaders and collaborators outside of BMS Partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials) Ability to lead and develop a group of CTPs to ensure scientific and technical excellence of clinical development programs and deliverables Education
MD required with a deep understanding of the clinical principles of the area of interest or equivalent therapy area knowledge Additional Requirements
Domestic and International travel may be required.
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