Senior Director, Clinical Development – Breast Cancer

🔥 17 hours ago

🇺🇸 United States – Remote

💵 $299.8k - $369.8k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

👻 Ghost score 1%

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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 successful execution of clinical development programs and deliverables • Partner across the organization, with external vendors, academicians, and collaboration partners • Participate in clinical program strategy and ensure activities are executed within expected scope, budget, and timelines • Help establish and grow Clinical Research functions and global capabilities • Work with clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research colleagues • Generate, author, update, and review protocols, informed consent documents, Investigator Brochures, clinical study reports, abstracts, posters, manuscripts, regulatory submissions, safety reports, clinical development plans, and risk/benefit analyses • Partner with clinical operations and other functions to implement and execute clinical studies • Provide scientific expertise for investigator and vendor selection • Train colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol • 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 internally and externally • Represent clinical studies or development programs on teams and sub-teams • Create clinical study and program-related slide decks • Build and maintain opinion leader/investigator networks and organize/present at advisory boards and investigator meetings • Conduct 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 goals and objectives • Support budget planning and management • Ensure compliant business practices

🎯 Requirements

• 6 plus years of experience within other biotech/pharmaceutical or relevant academic credentials companies • Advanced degree (MD or MD equivalent) with subspecialty training in oncology (preferred) and Breast Cancer experience a plus • Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials, from start up to study report • Ideally, having taken at least one study through from start to finish in a clinical scientist role • Clinical oncology experience; exceptional experience in other therapeutic areas may be considered if transferable 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% • Strategic leadership experience building, managing, and developing individuals and teams is preferred • Experience with the development and support of related SOPs and policies is expected • Knowledge of industry-standard Clinical Development IT solutions is 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 benefits • Reasonable accommodation for individuals protected by applicable laws