Clinical Development Executive Director guiding hematology clinical programs. Responsible for trial design, execution, and representing programs within Pfizer's global team.
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
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Senior Medical Director leading clinical trial operations and development strategies in Hematology at Pfizer. Engaging with global teams and maintaining clinical expertise in oncology development.
Clinical Director developing and implementing strategies for Admitting Physician Program and Inpatient Management. Ensuring compliance, metrics evaluation, and overseeing clinical guidelines with various healthcare agencies.
Clinical Director overseeing RMBHS clinical services, ensuring compliance and efficient operations. Collaborating with staff and administration to promote quality care in a healthcare setting.
Clinical Director managing clinical services and staff operations for a mental health agency. Ensuring compliance and improving service delivery while leading a multidisciplinary team.
Clinical Development Medical Director ensuring scientific integrity and well - being in clinical trials. Leading studies and delivering key clinical outcomes while maintaining compliance and managing risks.
Medical Director/Clinician overseeing clinical affairs at a health center serving underserved communities. Engaging with a dynamic healthcare team in New York City.
Medical Director overseeing healthcare providers at CHN health center. Delivering medical services and mentoring residents while ensuring the successful execution of Community Healthcare Network's mission.
Assistant Regional Clinical Director overseeing clinical operations for ABA services provided to individuals with Autism Spectrum Disorder. Leading BCBAs and driving quality and effectiveness across multiple states.
Global Medical Affairs Director at ViiV Healthcare ensuring effective communication of HIV prevention research. Leading training and data compliance efforts for clinical specialists and outside health care providers.