ADC Therapeutics
Medical Director, Clinical Development Physician (Contractor)
ADC Therapeutics, Myrtle Point, Oregon, United States, 97458
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.
We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn.
Position Overview We are seeking a full-time contractor to be our Medical Director, Clinical Development Physician, to work closely with cross-functional colleagues’ clinical development including 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.
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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.
We are a team of approximately 200 patient-focused, purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, operating in a flexible work environment, come join us on our journey! To learn more about ADC Therapeutics, our values, and our exceptional culture, please visit us at https://adctherapeutics.com/ and LinkedIn.
Position Overview We are seeking a full-time contractor to be our Medical Director, Clinical Development Physician, to work closely with cross-functional colleagues’ clinical development including 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.
#J-18808-Ljbffr