RPMGlobal
Executive Director, Clinical Development
RPMGlobal, New York, New York, United States,
The Role:
We are a dynamic and innovative company focused on harnessing the power of the immune system to bring curative therapies to cancer patients. Join us as the ED, Clinical Sciences at the most exciting time in our 25+ year history. Reporting to Agenus’ Chief Medical Officer, you will define strategy and drive implementation of drug development and scientific communications with a focus on mid to late-stage development. You will be responsible for shepherding a unique and deep portfolio of first in class assets from development to BLA filing and will be instrumental in building the company’s clinical development organization.
The successful leader will play a pivotal role in ensuring alignment between clinical strategy and clinical study protocols, operational structure, formalized processes, and tactical execution. This individual will enhance the execution of the vision, mission, and values of Agenus by keeping a watchful eye on the moving parts and the dynamic environment while ensuring teams and programs are moving forward within scope, schedule, and budget. In addition, the ED of Clinical Sciences will provide management and oversight for the Clinical Scientist team at Agenus.
In the role you will:
Clinical Study Design and Implementation:
Collaborate on design, initiate and implement phase I-III studies in partnership with cross-functional teams including medical directors, clinical operations, regulatory, biometrics, medical affairs, and competitive intelligence. Clinical support on implementation teams, providing subject matter expertise, clinical science support and functional representation.
Leadership and Team Management:
Establish and manage a team of Clinical Scientist professionals responsible for the development of clinical research protocols, clinical study reports, and scientific publications. Leading the Clinical Scientist team including allocating resources effectively, and driving strategic initiatives to advance clinical projects, fostering collaborative environments, budgeting and career development.
Strategic Leadership:
Interact with key opinion leaders, partners, and investigators to guide clinical development. Review, interpret, and communicate strategy, progress, and emerging data of ongoing research projects within and outside the organization. Ensure consistency of scientific and development strategies for assets in development. Maintain the highest level of ethics and scientific and clinical knowledge.
Communication:
Maintain timely and effective communication with stakeholders including the Agenus Leadership Team, clinical trial team, investigators, and regulatory authorities as needed. Metrics: Feedback from stakeholders including sites on the quality and timeliness of communication.
Regulatory and Compliance:
Oversee the coordination and development of reports submitted to the FDA, including responsibility for clinical sections of regulatory documents such as BLA filings. Ensure projects comply with federal regulations, GCP, and good medical practice. Write and/or review clinical sections of clinical/statistical reports, including data presentations and other regulatory submissions.
Data Management and Review:
Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team. Extensive experience with electronic systems for data review (RAVE, Spotfire). Hands on SOP development for data review to unify the activity across Agenus Programs. Coordinates process for protocol deviations and SAE reconciliation. Ensures consistent, quality data review and supports the clinical science team. Identifies and escalates clinical data trends to Medical Program Lead.
Safety and Pharmacovigilance:
Collaborate with and oversee pharmacovigilance in analyzing and reporting safety data from clinical trials. Provide comprehensive gap analyses for clinical development programs at risk. Draft safety narratives and review vendor-authored safety narratives to support various regulatory activities.
May serve as the Medical Monitor depending on prior experience and expertise.
Qualifications: About You
Degree in Life Sciences (MD, PhD, Pharm D) board certification in oncology and significant research experience in immuno-oncology.
Strong clinical training, deep industry expertise and a passion for clinical medicine, drug development and immuno-oncology: ten or more years in pharmaceutical/biotech industry or a combination of academia and industry.
Outstanding in-person and written communication skills.
Ability to thrive in a dynamic and innovative biotech environment with independence and collaboration.
Proven deep expertise in the design, execution, and reporting of phase II and III clinical trials in oncology including immuno-oncology.
Excellent scientific knowledge relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
In-depth knowledge of medical aspects of GCP, ICH, FDA, guidelines and regulations.
Proven leadership capabilities.
Decisiveness and the ability to perform as a respected team member and leader.
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We are a dynamic and innovative company focused on harnessing the power of the immune system to bring curative therapies to cancer patients. Join us as the ED, Clinical Sciences at the most exciting time in our 25+ year history. Reporting to Agenus’ Chief Medical Officer, you will define strategy and drive implementation of drug development and scientific communications with a focus on mid to late-stage development. You will be responsible for shepherding a unique and deep portfolio of first in class assets from development to BLA filing and will be instrumental in building the company’s clinical development organization.
The successful leader will play a pivotal role in ensuring alignment between clinical strategy and clinical study protocols, operational structure, formalized processes, and tactical execution. This individual will enhance the execution of the vision, mission, and values of Agenus by keeping a watchful eye on the moving parts and the dynamic environment while ensuring teams and programs are moving forward within scope, schedule, and budget. In addition, the ED of Clinical Sciences will provide management and oversight for the Clinical Scientist team at Agenus.
In the role you will:
Clinical Study Design and Implementation:
Collaborate on design, initiate and implement phase I-III studies in partnership with cross-functional teams including medical directors, clinical operations, regulatory, biometrics, medical affairs, and competitive intelligence. Clinical support on implementation teams, providing subject matter expertise, clinical science support and functional representation.
Leadership and Team Management:
Establish and manage a team of Clinical Scientist professionals responsible for the development of clinical research protocols, clinical study reports, and scientific publications. Leading the Clinical Scientist team including allocating resources effectively, and driving strategic initiatives to advance clinical projects, fostering collaborative environments, budgeting and career development.
Strategic Leadership:
Interact with key opinion leaders, partners, and investigators to guide clinical development. Review, interpret, and communicate strategy, progress, and emerging data of ongoing research projects within and outside the organization. Ensure consistency of scientific and development strategies for assets in development. Maintain the highest level of ethics and scientific and clinical knowledge.
Communication:
Maintain timely and effective communication with stakeholders including the Agenus Leadership Team, clinical trial team, investigators, and regulatory authorities as needed. Metrics: Feedback from stakeholders including sites on the quality and timeliness of communication.
Regulatory and Compliance:
Oversee the coordination and development of reports submitted to the FDA, including responsibility for clinical sections of regulatory documents such as BLA filings. Ensure projects comply with federal regulations, GCP, and good medical practice. Write and/or review clinical sections of clinical/statistical reports, including data presentations and other regulatory submissions.
Data Management and Review:
Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team. Extensive experience with electronic systems for data review (RAVE, Spotfire). Hands on SOP development for data review to unify the activity across Agenus Programs. Coordinates process for protocol deviations and SAE reconciliation. Ensures consistent, quality data review and supports the clinical science team. Identifies and escalates clinical data trends to Medical Program Lead.
Safety and Pharmacovigilance:
Collaborate with and oversee pharmacovigilance in analyzing and reporting safety data from clinical trials. Provide comprehensive gap analyses for clinical development programs at risk. Draft safety narratives and review vendor-authored safety narratives to support various regulatory activities.
May serve as the Medical Monitor depending on prior experience and expertise.
Qualifications: About You
Degree in Life Sciences (MD, PhD, Pharm D) board certification in oncology and significant research experience in immuno-oncology.
Strong clinical training, deep industry expertise and a passion for clinical medicine, drug development and immuno-oncology: ten or more years in pharmaceutical/biotech industry or a combination of academia and industry.
Outstanding in-person and written communication skills.
Ability to thrive in a dynamic and innovative biotech environment with independence and collaboration.
Proven deep expertise in the design, execution, and reporting of phase II and III clinical trials in oncology including immuno-oncology.
Excellent scientific knowledge relevant to clinical oncology (biochemistry, immunology, molecular biology and/or genetics).
In-depth knowledge of medical aspects of GCP, ICH, FDA, guidelines and regulations.
Proven leadership capabilities.
Decisiveness and the ability to perform as a respected team member and leader.
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