Medical Director, Clinical Development – Hematology/Oncology
Location: Remote, West Coast
Contact: info@bandishgroup.com
THE ROLE:
Medical Director, Clinical Development – Hematology/Oncology | Cell Therapy Company | Remote
DESCRIPTION:
We have been engaged to identify a Medical Director, Clinical Development within Hematology/Oncology for our client who is a pioneer in cell therapy research. This individual will provide medical monitoring to multiple clinical trials. Additionally, one will guide the project teams to design and implement clinical studies at high quality and in a time and cost-effective manner in line with the department and corporate goals and within regulatory and resource guidelines.
HIGHLIGHTS OF RESPONSIBILITIES:
Provide medical monitoring to multiple hematology/oncology clinical trials.
Lead project teams to design and implement hematology/oncology clinical studies.
Write protocols, investigator brochures, clinical study reports and review clinical trial documents.
Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
Implement and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
Translate findings from research and nonclinical studies into clinical development opportunities.
Interact with clinical investigators and thought leaders.
Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry and ensure compliance with these external guidelines.
Work with internal pre-clinical scientists, translational scientists, business and commercial organizations in a cross functional manner.
Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs.
Provide clinical expertise and input for regulatory filings (i.e., BLA, MAA) as well as responsd to questions from regulatory authorities in the context of IND submissions, clinical trial applications or filing procedures.
Provide clinical guidance and work in a team environment in interactions with external stakeholders (medical experts, advisory boards, patient advocacy groups) and internal stakeholders (Research, Translational Sciences, Clinical Operations, Safety, Regulatory, Medical Affairs, and Commercial).
DESIRED SKILLS AND QUALIFICATIONS:
MD/DO degree and 5+ years of clinical or biotech/pharma industry experience.
Board certification/specialization in Hematology or Oncology and experience managing oncology trials.
Myeloma experience.
Randomized phase 2 or 3 study experience.
Cell therapy experience.
3+ years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience.
Demonstrated clinical development strategist with experience designing, implementing and conducting clinical trials, with emphasis on proof-of-concept and first-in-human studies.
Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options.
CONTACT:
To learn more about this role, contact a member of our team at 267-483-5233 or info@bandishgroup.com.
The Bandish Group, LLC
Life Sciences Executive Search
Greater Philadelphia Region
www.bandishgroup.com