ADC Therapeutics
Medical Director, Clinical Development Physician (Contractor)
ADC Therapeutics, Trenton, New Jersey, United States
Medical Director, Clinical Development Physician (Contractor)
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Overview Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.
Why ADC Therapeutics ADC Therapeutics (NYSE) is a commercial global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non‑Hodgkin lymphoma ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other anti‑cancer therapeutics and in earlier lines of therapy to determine if it has potential to treat an even broader range of patients. In addition to ZYNLONTA, ADC Therapeutics has a PSMA‑targeting ADC in ongoing development.
Position Overview We are seeking a full‑time contractor to be our Medical Director, Clinical Development Physician, to work closely with cross‑functional colleagues in Clinical Operations, Safety, Regulatory, and Statistics. This role reports to VP Global Late‑Stage Clinical Development and is responsible for working primarily across late‑stage clinical programs and the potential for early‑stage development programs. For late‑phase clinical development, the role will assume responsibility for one or more clinical studies that focus on specific indications/label extensions or a whole development program until filing, and further for life cycle management post‑approval in close collaboration with Medical Affairs. An important part of this role’s responsibility is to work cross‑functionally with multiple other disciplines within the company on strategic development plans for initial registration and beyond in the US and globally. The position will be located in the US and able to travel as needed for business meetings and other on‑site visits. Expected length of this contract is 12 months with the potential for conversion.
What You’ll Do
Provide medical leadership for assigned clinical trials/programs including phase 1b/II, full phase 2 single arm studies and phase 3 randomized controlled studies.
Work with senior management, steering committees, and line functions to develop protocols and amendments, provide medical monitoring of study conduct and oversight of patient safety, provide medical leadership for the DMCs, and provide medical support for data analysis/trial reporting.
Serve as major point of contact with internal management, (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions for assigned programs for which the Clinical Development Physician has primary responsibility.
Assess eligibility packets, advise investigators on appropriate toxicity management based on protocol guidance and interface with the study team and investigators to provide medical guidance where needed.
Acts as director of clinical development strategies, working with team members in the US, Europe, LatAm, and Asia in clinical operations, regulatory affairs, preclinical development and statistics to support development of and propose the Clinical Development Plan, support the regulatory strategy, provide medical/scientific input and develop/review relevant clinical documents or parts thereof to ensure high quality of study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
Supervise the review, analysis and interpretation of study data, support communication of study results as assigned, write abstracts and manuscripts for publication of clinical data and results in collaboration with clinical scientists and external providers, as applicable, act as a reviewer for clinical documents for his/her own programs.
Requirements Who You Are
Medical degree and training from a recognized academic institution. Board Certified/Board Eligible Hematologist/Oncologist preferred.
2+ years of experience in Oncology Clinical Development in industry contributing to the management of clinical trials.
Clinical experience in Oncology or Malignant Hematology, with direct patient care in solid tumor/hematology malignancies, is strongly preferred.
Some knowledge and industry expertise in global clinical oncology drug development.
Familiarity with preclinical oncology research methodology to enable interpretation of preclinical data for devising FIH phase I clinical hypotheses and clinical planning purposes.
Familiarity with preparing INDs and CTAs if helpful.
Familiarity in preparing/reviewing CSRs, BLAs and/or NDAs is preferred.
Strong communication skills in one‑to‑one situations and presentation to large audiences in addition to comfort serving as an internal expert on their program.
Strong interpersonal skills with an outgoing, collaborative nature.
Ability to work in multidisciplinary teams.
Creative, innovative and a self‑starter.
ADC Therapeutics is proud to be an affirmative action/EEO employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.
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Get AI-powered advice on this job and more exclusive features.
Overview Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics, you will join a group of talented people who share this mission.
Why ADC Therapeutics ADC Therapeutics (NYSE) is a commercial global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization. Our CD-19-directed ADC for relapsed/refractory non‑Hodgkin lymphoma ZYNLONTA® (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other anti‑cancer therapeutics and in earlier lines of therapy to determine if it has potential to treat an even broader range of patients. In addition to ZYNLONTA, ADC Therapeutics has a PSMA‑targeting ADC in ongoing development.
Position Overview We are seeking a full‑time contractor to be our Medical Director, Clinical Development Physician, to work closely with cross‑functional colleagues in Clinical Operations, Safety, Regulatory, and Statistics. This role reports to VP Global Late‑Stage Clinical Development and is responsible for working primarily across late‑stage clinical programs and the potential for early‑stage development programs. For late‑phase clinical development, the role will assume responsibility for one or more clinical studies that focus on specific indications/label extensions or a whole development program until filing, and further for life cycle management post‑approval in close collaboration with Medical Affairs. An important part of this role’s responsibility is to work cross‑functionally with multiple other disciplines within the company on strategic development plans for initial registration and beyond in the US and globally. The position will be located in the US and able to travel as needed for business meetings and other on‑site visits. Expected length of this contract is 12 months with the potential for conversion.
What You’ll Do
Provide medical leadership for assigned clinical trials/programs including phase 1b/II, full phase 2 single arm studies and phase 3 randomized controlled studies.
Work with senior management, steering committees, and line functions to develop protocols and amendments, provide medical monitoring of study conduct and oversight of patient safety, provide medical leadership for the DMCs, and provide medical support for data analysis/trial reporting.
Serve as major point of contact with internal management, (principal) investigators, health authorities, IEC/IRB, consultants, opinion/thought leaders and academic institutions for assigned programs for which the Clinical Development Physician has primary responsibility.
Assess eligibility packets, advise investigators on appropriate toxicity management based on protocol guidance and interface with the study team and investigators to provide medical guidance where needed.
Acts as director of clinical development strategies, working with team members in the US, Europe, LatAm, and Asia in clinical operations, regulatory affairs, preclinical development and statistics to support development of and propose the Clinical Development Plan, support the regulatory strategy, provide medical/scientific input and develop/review relevant clinical documents or parts thereof to ensure high quality of study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
Supervise the review, analysis and interpretation of study data, support communication of study results as assigned, write abstracts and manuscripts for publication of clinical data and results in collaboration with clinical scientists and external providers, as applicable, act as a reviewer for clinical documents for his/her own programs.
Requirements Who You Are
Medical degree and training from a recognized academic institution. Board Certified/Board Eligible Hematologist/Oncologist preferred.
2+ years of experience in Oncology Clinical Development in industry contributing to the management of clinical trials.
Clinical experience in Oncology or Malignant Hematology, with direct patient care in solid tumor/hematology malignancies, is strongly preferred.
Some knowledge and industry expertise in global clinical oncology drug development.
Familiarity with preclinical oncology research methodology to enable interpretation of preclinical data for devising FIH phase I clinical hypotheses and clinical planning purposes.
Familiarity with preparing INDs and CTAs if helpful.
Familiarity in preparing/reviewing CSRs, BLAs and/or NDAs is preferred.
Strong communication skills in one‑to‑one situations and presentation to large audiences in addition to comfort serving as an internal expert on their program.
Strong interpersonal skills with an outgoing, collaborative nature.
Ability to work in multidisciplinary teams.
Creative, innovative and a self‑starter.
ADC Therapeutics is proud to be an affirmative action/EEO employer. EOE Minorities/Females/Protected Veterans/Disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.
#J-18808-Ljbffr