- Provide medical leadership for assigned clinical trials/programs including phase 1b/II and phase 3 studies.
- Work with senior management, steering committee, line functions to develop protocol/amendment, provide medical monitoring of study conduct and oversight of patient safety, provide medical leadership for IDMC and provide medical support for data analysis/trial reporting.
- 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 Program Leader has primary responsibility.
- Acts as director of clinical development strategies, working with team members in the US and Europe in clinical operations, regulatory affairs, preclinical development, and statistics to: develop (or support development) and proposes the Clinical Development Plan
- May interact with regulatory and global authorities regarding clinical research in support of submissions and product registration
- Develops and maintains good collaborations with key opinion leaders and clinicians in the field,
- Participates in Study Site Initiation visits, Investigator meetings, data monitoring committee meetings, etc. including creation/review of meeting presentations
- Acts as a Study and/or Project Team representative, participating in cross-functional development activities to provide medical/scientific input into e.g. business plan, project strategy, in/out licensing activities, etc. as assigned.
- Act as a reviewer for clinical documents beyond his/her own programs.
- Medical degree and training from a recognized academic institution. Board Certified/Board Eligible Hematologist/Oncologist preferred.
- 8+ years of experience in Clinical Development in designing and overseeing clinical trials in oncology with 5+ years experience in industry.
- Clinical experience in oncology, with experience in hematology malignancies, strongly preferred.
- Strong knowledge and expertise in clinical oncology and experience in clinical and drug development.
- Solid knowledge of preclinical oncology research methodology to enable interpretation of preclinical data for devising clinical hypotheses and clinical planning purposes.
- Experience preparing INDs and CTAs.
- Experience in preparing/reviewing BLAs and/or NDAs preferable.
- Strong management and leadership competencies.
- Strong communication skills in one-to-one situations and presentation to large audience.
- Strong interpersonal skills with an outgoing, collaborative nature.
- Ability to work in multidisciplinary teams.
- Creative, innovative and self-starter.
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Senior Director, Clinical Development Physician - New Providence, United States - ADC Therapeutics SA
Description
ApplyJob Type
Full-time
Description
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.
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 are a team of over 300 patient-focused, purpose-driven employees 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 journeyTo learn more about ADC Therapeutics, please visit us at and follow us on LinkedIn.
Position Overview
The Sr.
Director Clinical Development Physician is responsible for working primarily across late stage clinical programs as well as potentially some early stage programs across the organization.
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.
They may also assist on early stage programs, and work closely with the VP of Early Phase Development and 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 the 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, but potentially across all geographic areas.
The position will report to the VP of Late Stage Development and ideally will be located on the East Coast with the ability to travel to the New Providence, NJ office on a regular basis and travel as needed for business meetings and other on-site visits.
What You'll Do:
* provide medical/scientific input and develop/review relevant clinical documents or parts thereof to ensure high quality of e.g. study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc.
* complete 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.
Who You Are:
The successful candidate will be an innovative, sophisticated, and highly creative individual who thrives in a "get it done" type of environment with a strong track record of hands-on experience in oncology clinical development.
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/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
