Senior Director, Late-stage Clinical Development
Description
Cornerstone Search Group is working exclusively with an attractive, commercial-stage Biotech with its propriety technology, actively developing next-generation anti-cancer therapies. This company is a global leader in antibody-drug conjugates, with multiple ongoing studies for hematologic and solid tumor cancers.
The Senior Director/Physician will provide medical leadership primarily across late-stage clinical development. This role will involve being the clinical program lead and a pivotal member of select review and governance committees across the organization. This Physician will lead clinical studies focusing on specific indications/label extensions or a whole development program until filing, and further for life cycle management. This role will be charged with developing strategies and relationships with the investigators and navigating the discussions regarding patient selection for the trials. This Physician may also assist with early programs.
This Physician leader will serve as a subject-matter expert, strategist, and thought partner internally and externally. This is an extremely rewarding senior clinical role in which you will impact the development of additional therapies by working cross-functionally on strategic development plans for initial registration and beyond in the US and globally. You will report to an experienced VP who is collaborative, straightforward, patient-focused, and a great mentor. We've had the opportunity to partner with the Hiring Manager for many years and she's an excellent leader and person.
Location
Remote / Hybrid (position could be remote with minimal in office presence)
Features
- Exciting science and highly promising therapeutic programs for complicated cancers.
- Great opportunity to provide strategic input and medical leadership and to lead a high-priority clinical development program(s)/trials.
- A terrific opportunity to serve as a subject-matter expert and as a mentor to other staff.
- An excellent place to continue to grow your career with high visibility and leaders that are open to discussions.
- Join an established, commercial-stage Biotech with strong company culture and leadership with past ties to many leading oncology pharmas; highly collegial and collaborative atmosphere.
- Enjoy the best of what a Biotech has to offer, i.e., minimal layers of management, access/visibility to senior management, swift decision-making, fast timelines, tremendous growth, and more.
Qualifications / Requirements
- Medical Degree is required, with Hematology/Oncology training preferred. Therapeutic knowledge of Lymphoma and clinical experience with ADCs is highly preferred.
- Progressive clinical development experience gained working in Industry is required.
- Proven experience in hematology/oncology drug development, designing and managing clinical trials (Ph 1b/II and Ph III) through investigator and regulatory interactions; experience with early-clinical development, including FIH and IND, is a plus.
- Strategic and hands-on management and operational experience leading global clinical development programs/trials. Ability to handle more than one trial at a time.
- Direct experience with CTAs, BLAs, and/or NDAs. Creative, innovative, self-motivated, and self-starter.
- Strong ability to partner with other functions, including preclinical, early-stage clinical development, clinical operations, regulatory, and external collaborators.
- Strong leadership, communication, writing, and presentation skills with the ability to lead/manage/mentor other professionals.
- Team-oriented, collaborative, patient-value-focused, goal-driven, and organized.
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Keywords
senior director, clinical program lead, late-stage clinical development, clinical trials, global, strategy, hematology, lymphoma, oncology, targeted therapies, ADCs, antibody-drug conjugates, program, asset, label extension, life-cycle management, pharma, biotech, biopharma, MD, medical doctor, phase I, phase II, phase III, FDA