Director, Clinical Development

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $249.8k - $309.8k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Support BeOne Clinical and Medical assets through execution of clinical development programs and deliverables • Jointly develop clinical program strategy and help assure activities are executed within expected scope, budget, and timelines • Help establish and grow Clinical Research functions and global capabilities • Facilitate generation, authorship, updating, and review of protocols, informed consent documents, investigator brochures, clinical study reports, abstracts, posters, manuscripts, regulatory submissions, briefing documents, risk/benefit analyses, and clinical development plans • Partner with clinical operations and other functional areas to implement and execute clinical studies • Provide scientific expertise for investigator and vendor selection • Train BeOne colleagues, CRO staff, and study site staff • Provide scientific and medical support throughout clinical trials and respond to questions from sites, IRBs/IECs, Health Authorities, and CROs • Review, query, analyze, interpret, and present clinical trial data • Represent clinical studies or development programs on teams and subteams • Create clinical study and program-related slide decks • Build and maintain opinion leader/investigator networks; organize and present at advisory boards and investigator meetings • Conduct or contribute to therapeutic area/indication research and competitor analysis • Build relationships with internal experts • Identify process improvement opportunities and organizational resource needs • Develop, track, execute, and report on goals and objectives • Support budget planning and management • Ensure compliant business practices

🎯 Requirements

• MD, DO, PhD, PharmD or international equivalent degree required • 5 plus years of experience and success within other biotech/pharmaceutical companies • Previous participation in a clinical development program, including involvement in all stages of clinical trials from start up to study report • Clinical oncology experience, or exceptional experience in other therapeutic areas with clear potential to apply existing skills to oncology • Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing • High level of written and verbal communication, interpersonal, organizational, and cross functional collaboration skills • Knowledge of GCP and ICH Guidelines • Flexibility to work with colleagues in a global setting • Able to engage in work-related travel approximately 25% • Experience with the development and support of related SOPs and policies is expected • Knowledge of industry standard Clinical Development IT solutions expected

🏖️ Benefits

• Annual bonus plan eligibility for non-commercial roles • Incentive compensation plan eligibility for commercial roles • Discretionary equity awards • Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness

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