Senior Medical Director, Clinical Development
Day One Biopharmaceuticals
full-time
Posted on:
Location Type: Hybrid
Location: California, Massachusetts • 🇺🇸 United States
Visit company websiteSalary
💰 $320,000 - $350,000 per year
Job Level
Senior
About the role
- Provide medical and scientific expertise and oversight for clinical trials
- Act as the Medical Monitor for clinical trials, ensuring patient safety
- Engage in program-level activities, including authoring/reviewing safety and efficacy summaries, clinical overviews, and clinical sections of product labels
- Present study results to internal and external committees or advisory boards, as well as preparing data for presentation at international scientific meetings and publications
- Collaborate with the DAY301 Product Team Lead and lead the Clinical Development Sub-Team within the Product Team
- Provide oversight and leadership to the study/program clinical development team
- Ensure development of and/or adherence to safety review plans
- Perform and document regular review of individual subject safety data
- Interact with Regulatory Authorities and Internal Regulatory and QA Groups on a Study Level
- Assist in the preparation and delivery of clinical study reports and results for internal (corporate) and external (regulatory) purposes
Requirements
- MD or MD/PhD degree is required
- 7-10 years of experience in the biopharmaceutical industry with experience in oncology drug development and design/conduct of clinical trials
- Training and experience in oncology; pediatric oncology and/or neuro-oncology experience is preferred but not essential; board certified or eligible in oncology (and/or hematology)
- Knowledge of ICH and Good Clinical Practice and familiarity with global and regional regulations
- Experience in the assessment of adverse events and safety of patients participating in oncology clinical trials
- Skilled in modern oncology protocol design, data interpretation, biostatistics, and medical monitoring
- Strong interpersonal skills, as well as the ability to function in a team environment
- Ability to lead by example, build interdependent partnerships, and participate in a culture of collaboration and teamwork that fosters open communication, constructive conflict resolution and organizational flexibility
- Able to prioritize and manage several projects simultaneously
- Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines
- Proven ability to develop internal relationships in a matrix environment, whether in person or remotely, as well as external relationships with Key Opinion Leaders and industry experts
- Outstanding verbal, written, and presentation skills to enable effective communication at all levels that allows for the presentation of complex and/or new ideas with clarity and simplicity
- A desire to be part of a highly innovative company aimed at transforming the lives of children and adults with serious, life-threatening diseases, their families and society
- Exceptionally organized with keen attention to detail with the ability to shift focus and priorities when necessary, under pressure and within deadlines.
Benefits
- Competitive benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trialsoncology drug developmentmedical monitoringbiostatisticsprotocol designdata interpretationsafety review plansadverse event assessmentclinical study reportsGood Clinical Practice
Soft skills
interpersonal skillsleadershipteam collaborationcommunicationorganizational flexibilityproject managementrelationship buildingpresentation skillsconflict resolutionattention to detail
Certifications
MDMD/PhDboard certified in oncologyboard certified in hematology