Medical Director, Clinical Development: Lead Innovative Trials

Deciphera Pharmaceuticals, Inc.; Waltham (MA); Sur place; USD 248 000 - 341 000; Plein temps

Avantages offerts par ce poste

Competitive salary and annual bonus

401(k) retirement plan with company 1:

Medical, dental, vision insurance

Résumé du poste

Deciphera Pharmaceuticals, Inc. is seeking a Medical Director to provide clinical development leadership for one or more assets in early or late development.

You will foster collaboration with allied functions through outstanding communication and coordination, and may mentor clinical scientists as needed. Reporting to leadership, you will serve as medical monitor, contribute to study team activities, and author key clinical and regulatory documents while supporting business development and

Qualifications

• Medical degree or equivalent with 8+ years of combined academic and industry experience (post-medical school), including 3+ years of work on clinical trials.
• Experience with clinical trial design, conduct, and medical monitoring.
• Understanding of GCP/ICH and regional/local regulations.
• Familiarity with data review/analytics tools (Rave, J-Review, Spotfire, etc).
• Outstanding leadership, team, presentation, written and oral skills.
• Collaborative and flexible in personal interactions at all levels of the company.
• Ability to work proactively and effectively, with exceptional creative problem-solving skills.
• Excellent strategic planning, organizational and communication skills.
• Willingness to accommodate meetings across time zones as needed for project success.
• Up to 30% travel

Responsabilités

• Provide clinical development leadership to one or more programs.
• Contribute to clinical development strategy in alignment with enterprise goals and management.
• Serve as medical monitor for one or more studies.
• Perform ongoing clinical trial data review and cleaning in collaboration with clinical science and pharmacovigilance.
• Attend and contribute to study team meetings.
• Present clinical trial findings to management.
• Author clinical documents (protocol, investigator brochure).
• Author clinical portions of regulatory documents (IND, CTA, NDA, MAA or equivalent).
• 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.
• Contribute to writing of manuscripts, publications, or other documents intended for external audiences.
• Contribute in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates.
• Contribute to company culture and growth.
• Foster communication, collaboration and coordination with other functions.
• Contribute to maximizing synergistic collaboration between Ono and Deciphera.
• Contribute to assessment of new internal or external targets by outlining clinical challenges and opportunities.
• Support Medical Affairs activities as needed.
• Participate in and/or coordinate cross-functional continuous improvement projects.
• Act as an internal resource for functions requiring clinical input on select drug(s) including primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functions.

Description du poste

Deciphera Pharmaceuticals, Inc. is seeking a Medical Director to provide clinical development leadership for one or more assets in early or late development.

You will foster collaboration with allied functions through outstanding communication and coordination, and may mentor clinical scientists as needed. Reporting to leadership, you will serve as medical monitor, contribute to study team activities, and author key clinical and regulatory documents while supporting business development and