Senior Medical Director/Medical Director, Clinical Development - Oncology
Senior Medical Director/Medical Director, Clinical Development - Oncology
Meet
United States
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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.
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Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Health Care Provider and Science -
Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Medical insurance -
Dental insurance -
Vision insurance -
401(k) -
Paid maternity leave -
Paid paternity leave
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