Medical Director, Clinical Development – Neurology

🕒 il y a 2 mois

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $248 000 - $341 000 / an

⏰ Temps Plein

🔴 Expert

👨‍⚕️ Directeur Médical

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 5%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Deciphera Pharmaceuticals

Site WebLinkedInTous les Emplois

201 - 500 employés

Fondée en 2016

🏥 Santé

🏭 Fabrication

🧬 Biotechnologie

Healthcare • Manufacturing • Biotechnology

Deciphera Pharmaceuticals est une entreprise de biotechnologie dédiée à vaincre le cancer en développant des inhibiteurs de kinase innovants pour améliorer les résultats des patients. L'entreprise se concentre sur la conception d'inhibiteurs de kinase à contrôle de commutateur pour traiter les mécanismes de résistance tumorale et médicamenteuse, visant à améliorer les réponses aux traitements pour les patients atteints de cancer. Deciphera possède un portefeuille diversifié de candidats médicaments, y compris ripretinib et vimseltinib, et s'engage à avoir un impact significatif sur la vie des patients atteints de cancer. Depuis juin 2024, Deciphera est une filiale à part entière de ONO Pharma et continue de travailler à l'amélioration de la santé humaine grâce à ses innovations scientifiques et son approche centrée sur le patient.

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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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.