Planet Pharma
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http://www.theplanetgroup.com
http://www.theplanetgroup.com
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Senior Clinical Development Medical Director (REMOTE)
One Health Plaza East Hanover NJ USA 07936 East Hanover, NJ 07936 US
Posted: 03/10/2023
2023-03-10
2023-04-24
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 552635
Is job remote?: Yes
Country: United States
Job Description
Pay rate range: $193.91 - $240.73
CO and NYC candidates may not be considered
Major Activities
1) Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program or programs. Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications 2) Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigators Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) 3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates 4) Ensures ongoing medical and scientific review of clinical trial data 5) Is the Program or Function Manager of associates (e.g., CD(A)MD, CD(A)D, (A)GTD) 6) May act as study medical monitor 7) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety 8) Leads the Global Clinical Team (GCT), if there is a separate GCT for the assigned program section. Represents the section when needed in Global Program Team (GPT) meetings, and as the section spokesperson in internal and external meetings/boards, as needed 9) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH 10) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards 11) May work with (Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed 12) Ensures career development of Function and Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support 13) Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training 14) May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) Key Performance Indicators Timely delivery of high quality IDP sections, CTPs, and other clinical deliverables aligned with IDP and TPP and endorsed by review committees and internal boards, with acceptance by key external and internal stakeholders Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases Strong evidence of quality medical review of trial data; support TA through high quality IDP and protocol reviews; timely development of quality disease/program clinical standards, publications, internal/external presentations, and other CD deliverables Strong evidence of quality contributions to and acceptance of clinical sections of regulatory documents, Investigators Brochures, briefing books, safety updates, and submission dossiers by key external and internal stakeholders Well managed, effective, and engaged clinical teams; demonstrated ability to deputize for (Sr.) GPCH at GCT, as well as other venues as needed Clearly demonstrates Values and Behaviors Job Dimensions Number of associates: Leads team of up to 25 direct and indirect reports (dependent on the size of the programs and functional responsibilities)
Financial responsibility: Overall lifetime clinical budget of program which can vary and be in excess of $10 - 20 million Impact on the organization: External Timely submission and delivery of high quality clinical program data supporting regulatory approval of key compounds (or new indications), as appropriate Effective interaction with and influence on key external decision makers (e.g., regulatory authorities, medical experts, pricing and reimbursement bodies) Internal Medically and scientifically sound programs and trials resulting in the timely delivery of high quality analysis of trial data which enables strategic decisions within the clinical program High quality clinical/scientific review of CTPs and CDPs, industry leading clinical processes Identification and development of key talent Ideal Background (State the preferred education and experience level)
Education: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience 4 years (including residency) preferred Languages: Fluent oral and written English Experience/Professional requirement: 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 4 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry Advanced knowledge of assigned therapeutic area Demonstrated ability to establish strong scientific partnership with key stakeholders Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process 3 years people management experience required, this may include management in a matrix environment. Global people management experience desirable Excellent communication skills, written and oral Strong interpersonal skills Excellent negotiation and conflict resolution skills
CO and NYC candidates may not be considered
Major Activities
1) Provides clinical leadership and strategic guidance for all clinical deliverables in the assigned section of a clinical program or programs. Clinical deliverables may include the clinical development strategy for assigned program section(s), clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications 2) Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigators Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) 3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates 4) Ensures ongoing medical and scientific review of clinical trial data 5) Is the Program or Function Manager of associates (e.g., CD(A)MD, CD(A)D, (A)GTD) 6) May act as study medical monitor 7) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety 8) Leads the Global Clinical Team (GCT), if there is a separate GCT for the assigned program section. Represents the section when needed in Global Program Team (GPT) meetings, and as the section spokesperson in internal and external meetings/boards, as needed 9) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH 10) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards 11) May work with (Institute of Biomedical Research)/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed 12) Ensures career development of Function and Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support 13) Contributes to medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training 14) May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives) Key Performance Indicators Timely delivery of high quality IDP sections, CTPs, and other clinical deliverables aligned with IDP and TPP and endorsed by review committees and internal boards, with acceptance by key external and internal stakeholders Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases Strong evidence of quality medical review of trial data; support TA through high quality IDP and protocol reviews; timely development of quality disease/program clinical standards, publications, internal/external presentations, and other CD deliverables Strong evidence of quality contributions to and acceptance of clinical sections of regulatory documents, Investigators Brochures, briefing books, safety updates, and submission dossiers by key external and internal stakeholders Well managed, effective, and engaged clinical teams; demonstrated ability to deputize for (Sr.) GPCH at GCT, as well as other venues as needed Clearly demonstrates Values and Behaviors Job Dimensions Number of associates: Leads team of up to 25 direct and indirect reports (dependent on the size of the programs and functional responsibilities)
Financial responsibility: Overall lifetime clinical budget of program which can vary and be in excess of $10 - 20 million Impact on the organization: External Timely submission and delivery of high quality clinical program data supporting regulatory approval of key compounds (or new indications), as appropriate Effective interaction with and influence on key external decision makers (e.g., regulatory authorities, medical experts, pricing and reimbursement bodies) Internal Medically and scientifically sound programs and trials resulting in the timely delivery of high quality analysis of trial data which enables strategic decisions within the clinical program High quality clinical/scientific review of CTPs and CDPs, industry leading clinical processes Identification and development of key talent Ideal Background (State the preferred education and experience level)
Education: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience 4 years (including residency) preferred Languages: Fluent oral and written English Experience/Professional requirement: 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. 4 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry Advanced knowledge of assigned therapeutic area Demonstrated ability to establish strong scientific partnership with key stakeholders Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process 3 years people management experience required, this may include management in a matrix environment. Global people management experience desirable Excellent communication skills, written and oral Strong interpersonal skills Excellent negotiation and conflict resolution skills
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