Senior Medical Director, Clinical Development at Deciphera Pharmaceuticals, Inc

Senior Medical Director, Clinical Development

• Full-time
• Work Type: Full time
• Job Location: On-Site Waltham

Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in several countries including Australia, Canada, China, the European Union, and the United States. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.

We are seeking a Senior Medical Director, Clinical Development, with experience managing multidisciplinary drug development projects. The successful candidate will provide the clinical expertise to drive the development of our assets in various phases of development in different disease indications, ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall clinical development plans. This person is expected to closely collaborate and align with the cross-functional team.

This position will report to the VP, Late Clinical Development and work on-site at our Waltham, MA office. Deciphera expects a minimum number of three days a week on site, with flexibility as to hours on site on any given day to accommodate work/life balance.

What You’ll Do:

• Serve as a Program Medical Lead with oversight of all clinical trials in a specific program, contribute to program strategy and lifecycle management
• Serve as the Medical Director for specific clinical trials and lead a team of clinical scientist(s) and/or clinical trial physician(s)
• Review safety data for routine medical data review, trend review, and safety signals from ongoing trials
• Provide specific therapeutic area expertise to enhance innovation and efficiency in clinical development
• Collect external data and competitive intelligence in select kinase targets
• Author clinical sections in regulatory documents including IND submissions and study protocols
• Report clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance
• Contribute to writing of manuscripts, publications, or other documents intended for external audiences
• Act as an internal resource for functions requiring clinical input on select drug(s)
• Contribute to authoring of data review plans, medical monitoring plans, safety charters, and other specific management plans
• Support or prepare data, including interpretation, and clinical trial reports
• Contribute in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates
• Develop and manage relationships with key opinion leaders for clinical programs
• Organize, manage and lead Steering Committees and contribute to Strategic or Clinical Advisory Boards
• May manage/supervise clinical scientist(s) and clinical trial physician(s)
• Support Medical Affairs and Business Development as needed

Minimum Requirements:

• Medical Degree or equivalent, specialization in oncology is desirable
• Minimum of 5 years experience in pharmaceutical or biotech industries preferred
• Experience with clinical trial design, conduct, and medical monitoring
• Understanding of GCP/ICH and regional/local regulations
• Familiarity with data review/analytics tools
• Outstanding leadership and communication skills
• Ability to work proactively and effectively, with exceptional creative problem-solving skills
• Up to 30% travel

What Deciphera will Bring:

Deciphera offers a comprehensive benefits package that includes but is not limited to the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• Monthly cell phone stipend
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan with company match
• Life and Supplemental life insurance for family
• Short and Long Term Disability insurance
• Health savings account with company contribution
• Flexible spending account for either health care and/or dependent care.
• Generous parental leave

Deciphera is committed to equal employment opportunity and values diversity.