Clinical Development Director – Early Development, Inflammation/Rare Disease

🕒 il y a 2 mois

🇺🇸 États-Unis – Télétravail

💵 $274 788 - $371 773 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

🦅 Parrain de Visa H1B

Cette entreprise a parrainé des visas H1B par le passé.

👻 Score fantôme 25%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.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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Amgen

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1980

🏥 Santé

🧬 Biotechnologie

💊 Pharmaceutique

💰 €28 500 000 000 Post-IPO Debt en 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen est un leader mondial de la biotechnologie, se concentrant sur le développement et la commercialisation de médicaments innovants issus de cellules vivantes. L'entreprise vise à traiter des maladies graves, ciblant souvent des affections avec peu d'options thérapeutiques. Amgen met l'accent sur l'innovation scientifique et s'engage dans la recherche éthique, la sécurité des patients et le développement durable. Elle participe activement aux essais cliniques et est reconnue pour ses contributions dans les domaines du traitement du cancer et de la gestion de l'obésité, entre autres.

Description

• Lead the early phase clinical development of compounds from first-in-human studies through proof-of-concept • Collaborate on teams to support the design and delivery of early phase clinical trials • Support protocol and IND development, study start-up, data review, monitoring and analysis activities • Contribute to the design and implementation of early clinical development strategy for Inflammation, General Medicine or Rare Disease therapeutic candidates • Contribute to clinical development plans, clinical study protocols, informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions • Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data • Contribute to the strategy and use of clinical biomarkers to facilitate drug development • Collaborate with Precision Medicine, Research, Clinical Pharmacology, Operations, Late Development, Regulatory, Safety and Commercial colleagues • Contribute to evaluation of external licensing or partnering opportunities within cardiometabolic/general medicine therapeutic areas • Collaborate with external experts to provide biomedical expertise and strategic guidance to Early Development teams

🎯 Exigences

• MD or DO degree from an accredited medical school • 2 years of industry or academic/basic sciences/clinical development experience • Board certification or eligible (Internal Medicine, relevant subspecialty) (preferred) • Residency training in Internal Medicine and relevant subspecialty (preferred) • Understanding of pathophysiology of inflammatory, general medicine, and/or rare diseases (preferred) • Experience in basic research and/or clinical trial methodology (preferred) • 3+ years of relevant drug development experience in the pharmaceutical industry and/or academia, preferably in early stage clinical trials (preferred) • Experience collaborating with pharmaceutical sponsors (preferred) • Experience in designing, monitoring and implementing clinical trials and interpreting trial results (preferred) • Demonstrated leadership qualities; capable of conducting studies as part of a team (preferred) • Experience within a matrix environment, contributing to decision-making and reaching alignment in order to meet challenging timelines (preferred) • Publication track record (preferred) • Excellent interpersonal and presentation skills; able to communicate effectively with internal stakeholders, as well as external partners and collaborators (preferred) • Sponsorship for this role is not guaranteed

🏖️ Avantages

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • Discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals • Work/life balance

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