BCBA delivering clinical - behavioral assessments and support plans for adults with disabilities at Vinfen. Collaborating with multidisciplinary teams to enhance clients' quality of life.
About the role
- Medical Director leading clinical development strategies for innovative hematology therapies. Collaborating with teams to ensure compliance and execution of clinical programs.
Responsibilities
- Contribute to the overall clinical development strategy for assigned programs.
- Partner with the Executive Medical Director to define clinical development plans, trial designs, and program milestones.
- Provide medical and scientific input into target product profiles, study protocols, investigator brochures, and regulatory documents.
- Maintain awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.
- Critically evaluate available information about diseases of interest to the therapeutic area and the competitive landscape and synthesize information succinctly to support dissemination and incorporation into clinical development programs, asset plans and therapeutic area strategy
- Help to determine appropriate advisory boards experts
- Serve as medical monitor for clinical trials, ensuring subject safety and data integrity.
- Provide clinical guidance to operational teams, investigators, and external partners.
- Review and interpret clinical data, prepare clinical study reports, and support publication activities.
- Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSRs, and clinical expert reports
- Organize and present at relevant clinical advisory boards, DMC and medical/scientific meetings
- Collaborate with Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Medical Affairs to ensure seamless execution of clinical programs.
- Represent Clinical Development in internal governance meetings and cross-functional program teams.
- Support business development and alliance management activities as needed.
- Contribute to regulatory submissions (INDs, NDAs, BLAs, etc.) and interactions with global health authorities.
- Ensure compliance with GCP, ICH guidelines, and company SOPs.
- Prepare abstracts and manuscripts for publication/presentation.
- Present clinical data to internal stakeholders, investigators, and at scientific conferences.
- Provide mentorship to junior medical or scientific staff.
Requirements
- MD with research experience or MD/PhD, as well as a fellowship in Hematology/ Oncology or related areas with minimum of 10-12 years of related work experience
- Extensive experience in translational or clinical research related to drug development is required: biotech/ pharma experience favorably considered
- Experience with developing clinical regulatory strategy
- Strong academic record with high quality peer-reviewed publications that demonstrate research productivity
- Track record of effective cross-collaboration within an organization, among teams, and external groups/organizations
- Expertise in data analysis and presentation
- Knowledge in the principles of clinical research methodology, statistics, data analysis and interpretation
- Ability to clearly and effectively communicate to internal and external stakeholders orally and in writing
- Experience in interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.
- Experience in regulatory submissions and interactions with FDA/EMA preferred.
- This role may require up to 20% travel for investigator meetings, regulatory interactions, or conferences.
Benefits
- Comprehensive benefits
- Competitive compensation packages
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