Medical Director, MDS

🕒 il y a 7 mois

🇺🇸 États-Unis – Télétravail

⏰ Temps Plein

🔴 Expert

👨‍⚕️ Directeur Médical

👻 Score fantôme 27%

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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AskBio Inc.

Site WebLinkedInTous les Emplois

501 - 1000 employés

🏥 Santé

🏭 Fabrication

💼 Conseil

💰 €2 656 252 Grant - Asklepios BioPharmaceutical en 2020-09

Healthcare • Manufacturing • Consulting

AskBio Inc. est une entreprise de thérapie génique en phase clinique, spécialisée dans le développement de traitements basés sur le virus adéno-associé (AAV) pour les maladies rares et génétiques. Filiale à 100 % de Bayer AG, opérant de manière indépendante, AskBio fait progresser des programmes depuis la découverte jusqu'à la fabrication et le développement clinique, en s'appuyant sur des capsides, des promoteurs et des technologies de fabrication AAV propriétaires (par exemple, Pro10™ et neDNA™). La société mène des essais cliniques (par exemple, le programme AB-1009 pour la maladie de Pompe à début tardif), collabore avec des partenaires académiques et industriels, et met l'accent sur la recherche axée sur les patients pour répondre aux besoins médicaux non satisfaits.

Description

• Drive the overall clinical development strategy in alignment with function, program team and timelines for the GDNF gene therapy program across Phase 1–3 with specific focus on movement disorders • Serve as a Parkinson’s clinical expert in state-of-the-art, randomized, double-blind clinical trials with emphasis on maintenance of the blinding status of the trial • Serve as the medical lead for clinical trial design, protocol development, and endpoint strategy for movement disorders indications • Provide medical oversight for clinical trials, ensuring patient safety, data integrity, and regulatory compliance • Lead clinical risk–benefit assessments, including safety signal evaluation, dose escalation decisions, and go/no-go recommendations • Authoring support for regulatory interactions, including FDA meetings, briefing documents, and inspection readiness activities • Oversee long-term follow-up (LTFU) strategies required for gene therapy products, including delayed safety monitoring and post-treatment commitments • Guide and mentor Medical Directors and other clinical team members; contribute to clinical capability building • Partner with Clinical Operations, Biostatistics, Regulatory, and CMC to ensure integrated program execution • Present clinical strategy and data to senior leadership, governance committees, and external stakeholders • Ensure a culture of inspection readiness, quality, and continuous improvement across the clinical organization • Support the strategic vision for clinical development for the GDNF program and contribute to broader organizational clinical strategy as appropriate • Foster and maintain strong relationships with key opinion leaders (KOLs), investigators, and external scientific and clinical stakeholders • Oversee the integration of clinical development activities with cross-functional partners, including Regulatory, CMC/Manufacturing, Commercial, and Research, to ensure seamless program advancement • Represent the organization as a clinical and scientific leader in high-level industry forums, scientific meetings, advisory boards, and conferences

🎯 Exigences

• MD from an accredited U.S. medical school or equivalent international medical degree with 6+ years relevant clinical experience with Movement Disorders patients • Completion of clinical training with board certification or eligibility in Neurology or a closely related specialty with movement disorders specialization and clinical experience • Minimum of two years of industry experience or related experience in clinical development within the pharmaceutical, biotechnology, medical device, or CRO/CDMO environment • Demonstrated leadership in the design and execution of clinical trials across multiple phases, including oversight of clinical monitoring activities • Proven experience supporting FDA or global health authority inspections, audits, or formal inspection readiness initiatives • Working knowledge of GCP, regulatory requirements, and trial quality management systems • Ability to independently lead clinical programs and make program-level medical decisions in a regulated development environment • Strong strategic leadership and cross-functional influence. • Expertise in risk-based monitoring and clinical trial quality oversight • Strong analytical judgment applied to complex clinical and safety issues • Excellent communication and executive presentation skills • Ability to operate effectively in a fast-paced, evolving biotech environment • Proven track record of successful clinical program leadership, including advancing programs through critical development milestones • Exceptional strategic and operational planning skills, with the ability to translate long-term vision into executable clinical plans • Strong leadership presence with the ability to influence, inspire, and align cross-functional teams • Established professional network within the gene therapy and/or CNS development community • Understanding of market dynamics, competitive landscape, and evolving trends relevant to gene therapy and movement disorders.

🏖️ Avantages

• Health insurance • Retirement plans • Flexible work arrangements • Professional development opportunities