Senior Medical Director/Medical Director, Clinical Development - Oncology

Senior Medical Director/Medical Director, Clinical Development - Oncology

Essential Job Functions and Responsibilities:

Reporting to the VP/Head of Oncology Clinical Development, the ideal candidate will demonstrate excellence in both early and late-stage clinical strategies. They will develop and implement risk-based medical monitoring and serve as the primary medical information source for multiple early and late-stage studies, medical affairs, corporate governance, and project management.

Key Responsibilities:

Design, Develop & Support Global Studies:

• Lead and manage US based Phase I breast cancer study.
• Provide global medical monitoring support for a Phase III NSCLC study in the US and Europe.
• Oversee global medical monitoring for early development studies in the US, Korea, and Taiwan.
• Support business development activities and clinical activities for IND submissions.

Early & Late-Stage Clinical Development:

• Design programs and generate evidence for clinical development.
• Define the scientific, disease, and competitive landscapes, addressing unmet medical needs.
• Identify and collaborate with KOLs for study design inputs and advisory board meetings.
• Collaborate with corporate teams to position products in the commercial landscape.
• Drive end-to-end integrated clinical development strategies and lifecycle management.

Study Site Support:

• Maintain contact with sites and PIs to ensure patient safety and efficacy.
• Provide updates on the study and ensure data accuracy and compliance.
• Collaborate with Clinical Operations for patient recruitment as per protocol.

Medical Monitoring Oversight:

• Serve as the primary source of medical accountability and study oversight.
• Track lab alerts, assess medical values, and review AE, SAE data, and SUSARs.
• Define strategies for weekly safety surveillance and causality assessment.
• Ensure quality data for DMC/IDMC reviews and prepare study data for analysis.

Regulatory Support:

• Author clinical sections of regulatory documents for IND submissions.
• Lead clinical development discussions during regulatory interactions.
• Review CSRs, amendments, and safety summaries for NDA/BLA submissions.

Collaboration with China HQ/Study Cross-Functional Teams:

• Build a harmonious relationship with China HQ for better study understanding.
• Collaborate with global medical and project leads to understand project needs.
• Support interim analysis, CSR review, and regulatory submissions.

Medical Affairs Support:

• Plan stakeholder education and partnerships during product early development.
• Engage in scientific discussions with KOLs and build external expert interest.
• Develop and execute insights collection processes to inform product development.

Departmental Activities:

• Develop annual budgets and define roles and responsibilities.
• Oversee resource requirements, recruitment, training, and team building.

Building Global Support Proficiency:

• Contribute to protocols, IBs, drug safety update reports, and newsletters for global studies.

Job Requirements:

Experience/Education:

• 8+ years of experience in clinical development, scientific leadership, and strategy in advanced solid tumors, targeted therapies (HER2/HER3 ADCs), I-O, and cell therapies.
• MD or equivalent degree in a scientific field.

Knowledge/Skills/Abilities:

Knowledge:

• In-depth understanding of clinical applications based on scientific, medical, commercial, and practical rationale.
• Experience in developing and implementing disease product and location strategies according to ICH/GCP/WHO and IDMP standards.
• Expertise in risk-based medical monitoring, medical affairs, and medical/scientific liaison.

Skills:

• Proficient in early and late-stage clinical development, program design, and evidence generation.
• Ability to identify unmet medical needs and explore opportunities.
• Strong communication skills with cross-functional teams, CROs, KOLs, and corporate teams.
• Expertise in biomarkers, signaling pathways, genomic alterations, diagnostics, treatment, and prognosis assessments.
• Adept at building, mentoring, and leading global teams in a cross-functional, diverse environment.

Abilities:

• Capable of adopting new digital tools and technology to overcome obstacles.
• Implement innovative methods and processes to meet RSCI needs.
• Encourage innovative thinking and business solution development.
• Demonstrate thought leadership, effective communication, decision-making, conflict resolution, critical thinking, and interpersonal skills.
• Maintain a balanced emotional quotient and positive team interactions, fostering a collaborative and innovative work environment.