ADC Therapeutics
Medical Director, Clinical Development Physician (Contractor)
ADC Therapeutics, New Providence, New Jersey, us, 07974
Overview
Medical Director, Clinical Development Physician (Contractor) at ADC Therapeutics. The role is a full‑time contractor to work closely with cross‑functional clinical development teams including Clinical Operations, Safety, Regulatory, and Statistics. The position reports to the VP Global Late‑Stage Clinical Development and focuses on late‑stage programs with potential early‑stage involvement. Location: US, with travel as needed. Expected contract length: 12 months with potential for conversion. 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. 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. Act 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:
The Contractor will be an innovative, and experienced individual who thrives in a “get it done” type of environment, with a strong track record of hands‑on experience in global oncology clinical development. The candidate will have the following mix of personal and professional characteristics. 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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Medical Director, Clinical Development Physician (Contractor) at ADC Therapeutics. The role is a full‑time contractor to work closely with cross‑functional clinical development teams including Clinical Operations, Safety, Regulatory, and Statistics. The position reports to the VP Global Late‑Stage Clinical Development and focuses on late‑stage programs with potential early‑stage involvement. Location: US, with travel as needed. Expected contract length: 12 months with potential for conversion. 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. 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. Act 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:
The Contractor will be an innovative, and experienced individual who thrives in a “get it done” type of environment, with a strong track record of hands‑on experience in global oncology clinical development. The candidate will have the following mix of personal and professional characteristics. 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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