iCell Gene Therapeutics
iCell Gene is seeking an experienced medical director in the field of autologous CAR T cell therapies who will serve as our clinical research physician.
This is a hands-on role, responsible for providing both strategic guidance and operational execution excellence.
The successful candidate will provide strategic guidance for iCell Gene’s medical strategies in oncology, hematology and autoimmune diseases.
She/ he will also be accountable as the medical monitor/ medical lead to ensure the scientific integrity of study design, execution and reporting and to oversee clinical trial safety.
The successful candidate will also serve as the primary medical contact for clinical sites and investigators.
Candidates must possess a passion for cell therapy science and patients, as well as entrepreneurial drive to help the organization succeed.
Key responsibilities: ·
Provide strategic leadership to develop iCell Gene’s clinical development plan, m onitoring emerging clinical and scientific data to inform program direction and evidence generation plans,
working in close collaboration with research and development, manufacturing and leadership for alignment to corporate objectives
·
Draft clinical and medical deliverables including clinical study concepts,
clinical components of regulatory documents
(i.e. study protocols and amendments, informed consent forms, medical review plans )
and clinical trial operational documents (i.e.
investigator brochures, safety updates, and other study-related documents)
Serve as the primary medical contact for clinical trial sites, building productive relationships with investigators and clinical site study teams
·
Act as the study medical monitor;
monitoring and evaluating adverse events/ safety information, assessing safety signals, verifying participant consent and eligibility, ensuring the trial follows the protocol and regulatory guidelines and analyzing and interpreting the trial data
·
Drive execution of the clinical program
achieving project goals, within timelines, budget & with high quality
Lead/ support regulatory and compliance activities related to study execution including the preparation of safety reports (DSUR, SUSARs, safety section of IND and Annual Reports), relevant sections of regulatory documents, and health authority responses
Contribute to data analysis, interpretation, and dissemination of study results, including presentations at data monitoring boards, medical advisory boards, educational programs and conferences
Minimum Requirements ·
MD (or equivalent medical degree) required. Board certification in haematology, oncology, immunology, or related field preferred; 4+ years clinical practice experience preferred ·
7–10+ years of biotech/pharmaceutical experience in clinical development ·
Proven track record in leading clinical trials and regulatory submissions ·
Individual, hands-on accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) ·
2-5+ years of autologous cell therapy clinical trial experience with a s trong understanding of CAR T cell therapy, immuno-oncology, and autologous CAR T clinical trial processes. ·
Demonstrated ability to establish strong scientific partnerships with key partners / clinical sites ·
Thorough knowledge of FDA regulations and guidelines, Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory/clinical development processes ·
Direct experience collaborating with FDA and/or global regulatory agencies. ·
Excellent communication, collaboration and interpersonal skills. ·
Adaptable, self-starter that thrives in a small, fast-paced, innovative environment
This is a hands-on role, responsible for providing both strategic guidance and operational execution excellence.
The successful candidate will provide strategic guidance for iCell Gene’s medical strategies in oncology, hematology and autoimmune diseases.
She/ he will also be accountable as the medical monitor/ medical lead to ensure the scientific integrity of study design, execution and reporting and to oversee clinical trial safety.
The successful candidate will also serve as the primary medical contact for clinical sites and investigators.
Candidates must possess a passion for cell therapy science and patients, as well as entrepreneurial drive to help the organization succeed.
Key responsibilities: ·
Provide strategic leadership to develop iCell Gene’s clinical development plan, m onitoring emerging clinical and scientific data to inform program direction and evidence generation plans,
working in close collaboration with research and development, manufacturing and leadership for alignment to corporate objectives
·
Draft clinical and medical deliverables including clinical study concepts,
clinical components of regulatory documents
(i.e. study protocols and amendments, informed consent forms, medical review plans )
and clinical trial operational documents (i.e.
investigator brochures, safety updates, and other study-related documents)
Serve as the primary medical contact for clinical trial sites, building productive relationships with investigators and clinical site study teams
·
Act as the study medical monitor;
monitoring and evaluating adverse events/ safety information, assessing safety signals, verifying participant consent and eligibility, ensuring the trial follows the protocol and regulatory guidelines and analyzing and interpreting the trial data
·
Drive execution of the clinical program
achieving project goals, within timelines, budget & with high quality
Lead/ support regulatory and compliance activities related to study execution including the preparation of safety reports (DSUR, SUSARs, safety section of IND and Annual Reports), relevant sections of regulatory documents, and health authority responses
Contribute to data analysis, interpretation, and dissemination of study results, including presentations at data monitoring boards, medical advisory boards, educational programs and conferences
Minimum Requirements ·
MD (or equivalent medical degree) required. Board certification in haematology, oncology, immunology, or related field preferred; 4+ years clinical practice experience preferred ·
7–10+ years of biotech/pharmaceutical experience in clinical development ·
Proven track record in leading clinical trials and regulatory submissions ·
Individual, hands-on accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting, and publishing) ·
2-5+ years of autologous cell therapy clinical trial experience with a s trong understanding of CAR T cell therapy, immuno-oncology, and autologous CAR T clinical trial processes. ·
Demonstrated ability to establish strong scientific partnerships with key partners / clinical sites ·
Thorough knowledge of FDA regulations and guidelines, Good Clinical Practice, clinical trial design, statistical analysis methodology, and regulatory/clinical development processes ·
Direct experience collaborating with FDA and/or global regulatory agencies. ·
Excellent communication, collaboration and interpersonal skills. ·
Adaptable, self-starter that thrives in a small, fast-paced, innovative environment