ADC Therapeutics
Transforming Cancer Therapy Together
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.
What You’ll Do: The Director, Clinical Scientist, working in the Late-Stage Clinical Development team, will have a key role in the execution of ADC clinical trials to ensure data quality and integrity. The position will support the clinical development physicians and clinical study team and be responsible for design and scientific conduct of one or more clinical trials. This is a hybrid role and there is a preference for someone locally based near our New Providence, NJ office. Office time would be 1-2 days/month or as needed.
Job Responsibilities:
Authors Protocol and ICF documents/amendments, presents to development teams as required.
Works closely with clinical operations and Study Physician to ensure timely execution of trials with utmost focus on quality of data and study integrity
Works closely with the Study Physician to assure they are informed of pertinent study information, including but not limited to safety and efficacy data.
Performs data review on an ongoing basis, including data from vendors, AE/SAE reconciliation, etc. and follows data findings to ensure resolution.
Identifies study and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD.
Interacts and collaborates with the Safety physician and participates in the periodic safety data review meetings.
Develops sound, strategic solutions to issues as an integral member of the clinical study team to ensure issue resolution.
Conducts literature reviews as needed for the interpretation of study data and development of next steps.
Performs review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
Establishes and oversees operation of protocol steering committee, data monitoring committee, data safety monitoring board, independent response adjudication committee, etc.
Writes content for program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
Serves as clinical science representative on cross-function teams as assigned.
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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.
What You’ll Do: The Director, Clinical Scientist, working in the Late-Stage Clinical Development team, will have a key role in the execution of ADC clinical trials to ensure data quality and integrity. The position will support the clinical development physicians and clinical study team and be responsible for design and scientific conduct of one or more clinical trials. This is a hybrid role and there is a preference for someone locally based near our New Providence, NJ office. Office time would be 1-2 days/month or as needed.
Job Responsibilities:
Authors Protocol and ICF documents/amendments, presents to development teams as required.
Works closely with clinical operations and Study Physician to ensure timely execution of trials with utmost focus on quality of data and study integrity
Works closely with the Study Physician to assure they are informed of pertinent study information, including but not limited to safety and efficacy data.
Performs data review on an ongoing basis, including data from vendors, AE/SAE reconciliation, etc. and follows data findings to ensure resolution.
Identifies study and program issues by reviewing and monitoring of emerging clinical data related to safety, efficacy and PK/PD.
Interacts and collaborates with the Safety physician and participates in the periodic safety data review meetings.
Develops sound, strategic solutions to issues as an integral member of the clinical study team to ensure issue resolution.
Conducts literature reviews as needed for the interpretation of study data and development of next steps.
Performs review, analysis, and interpretation of study results and assures appropriate data review and accurate data reporting.
Establishes and oversees operation of protocol steering committee, data monitoring committee, data safety monitoring board, independent response adjudication committee, etc.
Writes content for program documents, including the clinical sections of various regulatory documents such as IND, clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
Serves as clinical science representative on cross-function teams as assigned.
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