Medical Director, Clinical Development – Neurology

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🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $248k - $341k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 Description

• 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.

🎯 Requirements

• Medical Degree or equivalent with 8+ years of combined relevant 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, Spotifre, 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.

🏖️ Benefits

• Competitive salary and annual bonus. • Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. • Generous parental leave and family planning benefits. • Outstanding culture and opportunities for personal and professional growth.