Senior Director, Clinical Development – Breast Cancer

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support to BeOne Clinical and Medical assets through the effective execution of clinical development programs and related deliverables.

• Collaborate across the organization, engaging with external vendors, academics, and collaboration partners.

• Contribute to clinical program strategies and ensure that activities are executed within the defined scope, budget, and timelines.

• Assist in establishing and expanding Clinical Research functions and global capabilities.

• Work alongside clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, molecular diagnostics, and translational research teams.

• 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.

• Collaborate with clinical operations and other functions to implement and execute clinical studies.

• Offer scientific expertise during the selection of investigators and vendors.

• Train colleagues, CRO staff, and study site personnel on the therapeutic area, molecule, and/or clinical protocol.

• Provide scientific and medical support throughout clinical trials and address inquiries from sites, IRBs/IECs, Health Authorities, and CROs.

• Review, query, analyze, interpret, and present clinical trial data both internally and externally.

• Represent clinical studies or development programs on teams and sub-teams.

• Create slide decks related to clinical studies and programs.

• Build and maintain networks with opinion leaders/investigators and organize/present at advisory boards and investigator meetings.

• Conduct research on therapeutic areas/indications and perform competitor analyses.

• Foster relationships with internal experts.

• Identify opportunities for process improvement and assess organizational resource needs.

• Develop, track, execute, and report on goals and objectives.

• Support budget planning and management.

• Ensure adherence to compliant business practices.

⛳️ Requirements

• Over 6 years of experience in biotech/pharmaceutical companies or relevant academic credentials.

• Advanced degree (MD or equivalent) with subspecialty training in oncology (preferred), with experience in Breast Cancer being advantageous.

• Essential prior involvement in a clinical development program, encompassing all phases of clinical trials from startup to study report.

• Ideally, experience in successfully guiding at least one study from start to finish in a clinical scientist capacity.

• Clinical oncology experience is required; exceptional experience in other therapeutic areas may be considered if transferable to oncology.

• In-depth understanding of global clinical study design and the drug development process from discovery to registration and post-marketing.

• Strong written and verbal communication, interpersonal, organizational, and cross-functional collaboration skills.

• Familiarity with GCP and ICH Guidelines.

• Flexibility to collaborate with colleagues in a global environment.

• Willingness to engage in work-related travel, approximately 25% of the time.

• Preferred strategic leadership experience in building, managing, and developing individuals and teams.

• Expected experience in developing and supporting related SOPs and policies.

• Familiarity with industry-standard Clinical Development IT solutions is expected.

🏝️ Benefits

• Eligibility for an annual bonus plan 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) plan.

• Flexible Spending Account (FSA) / Health Savings Account (HSA).

• Life Insurance coverage.

• Paid Time Off.

• Wellness benefits.

• Reasonable accommodations for individuals protected by applicable laws.