What are the responsibilities and job description for the Senior Medical Director, Clinical Development Physician position at ADC Therapeutics?
Job Type
Full-time
Description
Senior Medical Director, Clinical Development Physician
Hybrid/USA
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 a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has been approved in the United States and has also received European Commission approval. ZYNLONTA® is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients. We consist of nearly 300 dedicated employees, all focused-on patient care and driven by purpose, who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!
To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on Twitter and LinkedIn.
Position Overview
The Senior Medical Director, Clinical Development Physician, will 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 as well as early-stage 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. This individual will also support early-stage programs, and work closely with the R&D line function on preclinical programs to ensure appropriate planning for the filing of INDs to become the clinical program lead on first in human (FIH) studies for these molecules. 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. As the clinical program lead for global early and/or late phase clinical development programs, this role will be a pivotal member of select review and governance committees across the organization.
The position ideally will be located in the US and able to travel as needed for business meetings and other on-site visits.
What You’ll Do:
Who You Are:
The successful candidate will be an innovative, and highly 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:
Attention: Search firms/Third-party recruitment agencies
The People team manages the recruiting for all positions at ADC Therapeutics. We will only accept résumés from a search agency/recruiter if we have a signed agreement in place and we have formally requested your help on a specific role. Forwarding unsolicited resumes on behalf of potential candidates and/or vendor engagement requests to ADC Therapeutics hiring managers is strictly prohibited. Unsolicited résumés sent to ADCT will be considered property of ADCT. We will not be responsible for any fees associated should we hire from unsolicited résumés. Please send all emails and requests to recruiting@adctherapeutics.com.
Full-time
Description
Senior Medical Director, Clinical Development Physician
Hybrid/USA
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 a constantly expanding technology toolbox. We are experts in the lifecycle of ADCs – starting with creation all the way through to commercialization. We have a robust pipeline of ADCS in clinical trials for both hematologic and solid tumor cancers. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma, ZYNLONTA® (loncastuxamab tesirine lpyl) has been approved in the United States and has also received European Commission approval. ZYNLONTA® is also being evaluated in combination with other anti-cancer therapeutics to determine if it has potential to treat an even broader range of patients. We consist of nearly 300 dedicated employees, all focused-on patient care and driven by purpose, who carry out our mission in a flexible work environment. If you’re interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues, come join us on our journey!
To learn more about ADC Therapeutics, please visit us at https://adctherapeutics.com/ and follow us on Twitter and LinkedIn.
Position Overview
The Senior Medical Director, Clinical Development Physician, will 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 as well as early-stage 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. This individual will also support early-stage programs, and work closely with the R&D line function on preclinical programs to ensure appropriate planning for the filing of INDs to become the clinical program lead on first in human (FIH) studies for these molecules. 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. As the clinical program lead for global early and/or late phase clinical development programs, this role will be a pivotal member of select review and governance committees across the organization.
The position ideally will be located in the US and able to travel as needed for business meetings and other on-site visits.
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.
- 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:
- Develop (or 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
- Acts as a Study and/or Project Team representative, participating in cross-functional development activities to provide medical/scientific input into: business plans, project strategy, in/out licensing activities, etc.
- Act as a reviewer for clinical documents beyond his/her own programs.
Who You Are:
The successful candidate will be an innovative, and highly 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.
- 8 years of experience in Oncology Clinical Development in industry or academia designing and overseeing clinical trials.
- Clinical experience in Oncology, with direct patient care in solid tumor/hematology malignancies, is strongly preferred.
- Strong knowledge and industry expertise in global clinical oncology drug development.
- Solid knowledge of preclinical oncology research methodology to enable interpretation of preclinical data for devising FIH phase I clinical hypotheses and clinical planning purposes.
- Experience preparing INDs and CTAs.
- Experience in preparing/reviewing BLAs and/or NDAs preferred.
- Strong management and leadership competencies.
- Strong communication skills in one-to-one situations and presentation to large audiences.
- Strong interpersonal skills with an outgoing, collaborative nature.
- Ability to work in multidisciplinary teams.
- Creative, innovative and a self-starter.
Attention: Search firms/Third-party recruitment agencies
The People team manages the recruiting for all positions at ADC Therapeutics. We will only accept résumés from a search agency/recruiter if we have a signed agreement in place and we have formally requested your help on a specific role. Forwarding unsolicited resumes on behalf of potential candidates and/or vendor engagement requests to ADC Therapeutics hiring managers is strictly prohibited. Unsolicited résumés sent to ADCT will be considered property of ADCT. We will not be responsible for any fees associated should we hire from unsolicited résumés. Please send all emails and requests to recruiting@adctherapeutics.com.
