Medical Director, Clinical Development – Neurology

🔥 16 hours ago

🍂 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

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

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 at the study level for one or more clinical-stage assets in early and/or late development • Foster collaboration with allied functions through communication, collaboration, and coordination • Mentor and manage one or more clinical scientists as needed • Contribute to business development and continuous improvement activities • Contribute to clinical development strategy aligned with enterprise goals and management • Serve as medical monitor for one or more studies • Perform ongoing clinical trial data review and cleaning with clinical science and pharmacovigilance • Attend and contribute to study team meetings • Present clinical trial findings to management • Author clinical documents, including protocols and investigator brochures • Author clinical portions of regulatory documents, including IND, CTA, NDA, and MAA submissions • Develop and manage relationships with key opinion leaders • Organize, manage, and lead Steering Committees and contribute to Strategic or Clinical Advisory Boards • Contribute to manuscripts, publications, and other external-facing documents • Support Medical Affairs activities as needed • Participate in or coordinate cross-functional continuous improvement projects • Act as an internal clinical resource and primary contact for clinical trial staff at study sites on clinical issues, as well as for regulatory, safety, and other functions • Foster communication and collaboration across functions and between Ono and Deciphera • Assess new internal or external targets by outlining clinical challenges and opportunities

🎯 Requirements

• Medical Degree or equivalent • 8+ years of combined relevant academic and industry experience post-medical school • 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 such as Rave, J-Review, and Spotfire • Outstanding leadership, team, presentation, written, and oral skills • Collaborative and flexible interpersonal approach • 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 • Board certification in Neurology preferred • Experience in Phase 3 clinical development preferred • Experience interacting with the FDA and regulatory agencies outside the USA preferred • Experience in basic or translational science preferred

🏖️ Benefits

• Equity-based compensation • Medical insurance • Dental insurance • Vision insurance • 401(k) retirement plan with company match • Life insurance • Flexible spending account for health care and/or dependent care • Annual performance bonus • Long-term incentive plan • Generous parental leave • Family planning benefits • Opportunities for personal and professional growth • Up to 30% travel