Director, Clinical Development, Lead Medical Monitor

About the role

The Director, Clinical Development position at BeOne is a critical role supporting the clinical development of the company's clinical and medical assets. This role involves facilitating the generation and review of key documents, collaborating with various departments, and ensuring clinical studies are executed efficiently and compliantly.

Responsibilities

• Facilitate generation of, author, update, and/or review key documents, including protocols, informed consent documents, investigator brochures, abstracts, posters, manuscripts, and IND/NDAs.
• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies.
• Provide scientific expertise for selection of investigators and vendors.
• Train BeOne colleagues, CRO staff, and study site staff on the therapeutic area, molecule, and/or clinical protocol.
• Respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs.
• Review, query, and analyze clinical trial data.
• Interpret and present clinical trial data both internally and externally.
• Create clinical study or program-related slide decks for internal and external use.
• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.
• Contribute to or perform therapeutic area/indication research and competitor analysis.
• Identify continuous process improvement opportunities.
• Identify incremental organizational resource needs – staff, budget, and systems.
• Develop, track, execute and report on goals and objectives.
• Support budget planning and management.
• Be accountable for compliant business practices.

Requirements

• 5+ years of experience and success within biotech/pharmaceutical companies.
• Previous participation in a clinical development program, including involvement in all stages of clinical trials (start-up to study report).
• Expert understanding of global clinical study design and drug development process from discovery to registration and post-marketing.
• Strong communication (written and verbal), 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 leader with demonstrated success building, managing, and developing individuals and teams.
• Experience with the development and support of related SOPs and policies.
• Knowledge of industry standard Clinical Development IT solutions.

Qualifications

• MD or foreign equivalent.
• Previous experience in clinical oncology or other therapeutic areas with clear potential to apply existing skills to oncology.
• High level of communication (written and verbal), 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 leader with demonstrated success building, managing, and developing individuals and teams.
• Experience with the development and support of related SOPs and policies.
• Knowledge of industry standard Clinical Development IT solutions.

Skills

• Ability to manage multiple projects in a fast-paced environment.
• Values-based collaborator – respectful, accountable, and collaborative.
• Impactful written and verbal scientific communication.
• Successful and superior influencing skills across all levels of the organization and external collaborators.
• Problem-solving and risk-mitigation skills.
• Confident, positive attitude.
• Appreciation of diversity and multiculturalism.
• Strategic and creative thinker.
• Ability to build working relations throughout the organization and with business partners to achieve business goals.
• Strong time management and organizational skills.
• Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.

Benefits

BeOne offers a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. Additionally, all employees have the opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan. The Company also participates in an annual bonus plan for non-commercial roles and an incentive compensation plan for commercial roles.

Pay

$249,800.00 - $309,800.00 annually

Schedule

Full-time