drjobs Senior Medical Director Clinical Development Physician

Senior Medical Director Clinical Development Physician

Employer Active

1 Vacancy
drjobs

Job Alert

You will be updated with latest job alerts via email
Valid email field required
Send jobs
Send me jobs like this
drjobs

Job Alert

You will be updated with latest job alerts via email

Valid email field required
Send jobs
Job Location drjobs

New Providence, NJ - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Fulltime
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 antibodydrug 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 CD19directed ADC for relapsed/refractory nonHodgkin 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 anticancer therapeutics to determine if it has potential to treat an even broader range of patients. We consist of nearly 300 dedicated employees all focusedon patient care and driven by purpose who carry out our mission in a flexible work environment. If youre interested in making a difference in the lives of patients worldwide with a team of likeminded colleagues come join us on our journey!


To learn more about ADC Therapeutics please visit us at https://adctherapeutics/ and follow us on Twitter and LinkedIn.



Position Overview

The Senior Medical Director Clinical Development Physician will work closely with crossfunctional colleagues clinical development including Clinical Operations Safety Regulatory and Statistics. This role reports to VP Global LateStage Clinical Development and is responsible for working primarily across latestage clinical programs as well as earlystage programs. For latephase 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 postapproval in close collaboration with Medical Affairs. This individual will also support earlystage 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 roles responsibility is to work crossfunctionally 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 onsite visits.


What Youll 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:
  1. Develop (or support development) of and propose the Clinical Development Plan
  2. Support the regulatory strategy
  3. 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.
  4. Supervise the review analysis and interpretation of study data
  5. Support communication of study results as assigned
  6. Write abstracts and manuscripts for publication of clinical data and results in collaboration with clinical scientistsand external providers as applicable
  • Acts as a Study and/or Project Team representative participating in crossfunctional 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.


Requirements

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 handson 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 onetoone situations and presentation to large audiences.
  • Strong interpersonal skills with an outgoing collaborative nature.
  • Ability to work in multidisciplinary teams.
  • Creative innovative and a selfstarter.



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.



Attention: Search firms/Thirdparty recruitment agencies

The People team manages the recruiting for all positions at ADC Therapeutics. We will only accept rsums 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 rsums sent to ADCT will be considered property of ADCT. We will not be responsible for any fees associated should we hire from unsolicited rsums. Please send all emails and requests to




Required Experience:

Director

Employment Type

Full-Time

Company Industry

About Company

Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.