Senior Director, Clinical Development - Cell Therapy
Scorpion Therapeutics, California, Missouri, United States, 65018
Role Summary
The Sr. Director, Clinical Development is a pivotal role within our organization, responsible for providing clinical leadership and strategic direction for one of our cutting-edge cell therapy programs, including those in pivotal stage development. This individual will play a crucial role in advancing our cell therapy initiative from early-phase research through to commercialization. Responsibilities
Lead the design, implementation, and oversight of clinical trials for cell therapy products. Analyze and interpret clinical trial data and provide medical input for clinical study reports. Ensure the scientific integrity of clinical studies and compliance with regulatory requirements. Represent the company at scientific conferences, industry meetings, and in interactions with key opinion leaders (KOLs). Oversee the monitoring and reporting of adverse events and safety signals, ensure patient safety and ethical conduct of clinical trials and develop and implement risk management strategies. Collaborate with regulatory affairs to prepare and review regulatory submissions (IND, BLA, etc.). May develop and review scientific content for regulatory documents, scientific communications and marketing materials. Provide guidance and mentorship to members of the clinical development team; support professional development opportunities for team members. May represent clinical development in executive leadership meetings and contribute to strategic decision-making processes. Participate in cross-functional project teams and contribute to strategic planning. Provide medical expertise to support product development, marketing, and sales teams. Ensure adherence to all regulatory guidelines and Good Clinical Practice (GCP) standards. Substantially develop the Clinical Development Plan (CDP) and clinical trial protocols. Qualifications
Preferred Education:
M.D. or M.D./PhD; current/prior board certification in oncology, hematology, or a related field is preferred. 8+ years of related experience
Preferred Experience:
Minimum of 5 years of clinical research experience in oncology; experience with cell or immunotherapy is preferred. Demonstrated experience in the design, execution, and oversight of clinical trials. Experience with regulatory submissions and interactions with regulatory agencies is highly desirable.
Skills
In-depth knowledge of regulatory requirements and GCP standards. Strong analytical and problem-solving skills, with the ability to interpret complex clinical data. Excellent leadership and cross-functional collaboration/team leadership capability. Strong communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels. Ability to manage multiple priorities in a fast-paced, dynamic environment. Education
Preferred: M.D. or M.D./PhD; board certification in oncology, hematology, or related field.
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The Sr. Director, Clinical Development is a pivotal role within our organization, responsible for providing clinical leadership and strategic direction for one of our cutting-edge cell therapy programs, including those in pivotal stage development. This individual will play a crucial role in advancing our cell therapy initiative from early-phase research through to commercialization. Responsibilities
Lead the design, implementation, and oversight of clinical trials for cell therapy products. Analyze and interpret clinical trial data and provide medical input for clinical study reports. Ensure the scientific integrity of clinical studies and compliance with regulatory requirements. Represent the company at scientific conferences, industry meetings, and in interactions with key opinion leaders (KOLs). Oversee the monitoring and reporting of adverse events and safety signals, ensure patient safety and ethical conduct of clinical trials and develop and implement risk management strategies. Collaborate with regulatory affairs to prepare and review regulatory submissions (IND, BLA, etc.). May develop and review scientific content for regulatory documents, scientific communications and marketing materials. Provide guidance and mentorship to members of the clinical development team; support professional development opportunities for team members. May represent clinical development in executive leadership meetings and contribute to strategic decision-making processes. Participate in cross-functional project teams and contribute to strategic planning. Provide medical expertise to support product development, marketing, and sales teams. Ensure adherence to all regulatory guidelines and Good Clinical Practice (GCP) standards. Substantially develop the Clinical Development Plan (CDP) and clinical trial protocols. Qualifications
Preferred Education:
M.D. or M.D./PhD; current/prior board certification in oncology, hematology, or a related field is preferred. 8+ years of related experience
Preferred Experience:
Minimum of 5 years of clinical research experience in oncology; experience with cell or immunotherapy is preferred. Demonstrated experience in the design, execution, and oversight of clinical trials. Experience with regulatory submissions and interactions with regulatory agencies is highly desirable.
Skills
In-depth knowledge of regulatory requirements and GCP standards. Strong analytical and problem-solving skills, with the ability to interpret complex clinical data. Excellent leadership and cross-functional collaboration/team leadership capability. Strong communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels. Ability to manage multiple priorities in a fast-paced, dynamic environment. Education
Preferred: M.D. or M.D./PhD; board certification in oncology, hematology, or related field.
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