Senior Medical Director, Clinical Development, Hematology, Nephrology, & Transplant, Cell Therapy
$288,059–$432,089 year
On-siteBoston, Massachusetts, United States
Job Summary
Lead clinical development strategy and execution for a program in hematology, nephrology, or transplant, overseeing the design and management of multiple clinical studies. Represent Clinical Development on the Global Program Team, presenting to management committees and leading regulatory strategy discussions. Supervise Medical Directors and Clinical Development Scientists, guiding the preparation of protocols, regulatory documents, and study reports. Evaluate the competitive landscape and therapeutic area data to inform asset plans and advisory board selections. Liaise with cross-functional teams including biostatistics and regulatory to drive overall program strategy.
Required Qualifications
- MD or equivalent
- expertise in nephrology
- 10 plus years of clinical experience
- Experience as a medical monitor for clinical trials
- Excellent written / oral communication skills
- Attention to detail
- ability to think strategically
- Willingness to take on new responsibilities
- Interest and ability to learn about new therapeutic areas
- Interest in career progression and ability to take on a more senior roles in 1-3 years
- use a computer
- engage in communications via phone, video, and electronic messaging
- problem solve
- engage in complex and non-linear thought, analysis, and dialogue
- collaborate with others
- maintain general availability during standard business hours
Desired Qualifications
- 10 plus years of clinical experience preferably within industry
- minimum of 3 years of industry experience
- Experience as a medical monitor for clinical trials
- Regulatory experience
- Publication in peer reviewed journals
- Advanced knowledge of the assigned therapy area
- capability to interpret, discuss and represent trial or program level data
- 5+ years of industry experience in clinical development
- Experience for medical responsibilities on a cross-functional team
- Basic statistical knowledge
- Understanding of general (and specific) therapeutic principles
- Experience designing and executing industry-sponsored clinical trials
- Broad experience in the principles of clinical trial methodology, statistics, data analysis and interpretation
- Expert in scientific literature searches and weighing of quality peer reviewed data
- Experience authoring study essential documents, Clinical Study Reports, and regulatory documents
- Strong relevant therapeutic area experience
- Ability to clearly communicate to internal and external stakeholders orally and in writing
- Experience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
- Strong business acumen
- in-depth knowledge of the multidisciplinary functions involved in a company's drug development process
- Ability to prioritize multiple tasks and goals to ensure completion in a timely manner within budget
- Ability to think both strategically and tactically
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