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Executive Medical Director - Hematology
151102
Posted:
27/09/2024
- 300000 USD - 380000 USD
- Emeryville, United States
- Permanent
The Executive Medical Director will be responsible for driving the clinical development efforts within the Hematology therapeutic area, guiding both early and late-stage programs. The individual will collaborate across the organization with internal teams, external vendors, academic institutions, and strategic partners to ensure successful execution of clinical strategies and deliverables. Reporting to the Vice President of Clinical Development for Hematology, this leadership position will shape the overall clinical program strategy, ensuring projects are completed on time, within budget, and meet all regulatory and organizational expectations. A key focus will be on enhancing the Clinical Research functions, establishing robust capabilities for global execution. The role requires close collaboration with key areas including program leadership, clinical operations, safety, biometrics, regulatory, molecular diagnostics, and translational research.
Key Responsibilities:
- Develop and oversee protocol designs, synopses, and amendments.
- Author and review informed consent documents and Investigator Brochures.
- Prepare clinical study reports, abstracts, posters, and manuscripts.
- Contribute to the clinical sections of regulatory submissions, including INDs, NDAs, and related documents.
- Conduct risk-benefit analysis for clinical program documents.
- Design and implement Clinical Development Plans.
- Work with cross-functional teams to ensure successful planning and execution of clinical trials.
- Provide scientific expertise for the selection of investigators and vendors.
- Offer medical guidance and address clinical inquiries throughout the conduct of trials, including responses to sites, ethics committees, regulatory authorities, and CROs.
- Analyze and interpret clinical trial data, presenting findings to both internal and external stakeholders.
- Represent clinical studies or programs in various team settings and provide leadership in cross-functional meetings.
- Develop presentation materials and slide decks for internal and external audiences.
- Build and maintain strong relationships with key opinion leaders and investigators.
- Lead advisory boards and investigator meetings, contributing to scientific discussions.
- Conduct research on therapeutic areas and competitors to inform clinical strategy.
- Drive continuous process improvements within the clinical development function.
- Assist in resource planning, budgeting, and staffing decisions.
- Ensure all clinical activities are carried out in compliance with regulatory requirements and organizational standards.
Qualifications:
- Medical Doctor (MD or equivalent), preferably with specialized training in Hematology or Oncology.
- Minimum of 8 years of experience in the pharmaceutical, biotech, or related academic fields.
- Proven experience leading clinical development programs across all trial phases, including end-to-end involvement in at least one clinical trial.
- Oncology expertise preferred, though candidates from other therapeutic areas will be considered if they demonstrate the ability to transition to oncology.
- Deep knowledge of global clinical trial design, drug development processes, and regulatory requirements.
- Strong leadership and communication skills, with experience in cross-functional collaboration.
- In-depth understanding of Good Clinical Practice (GCP) and ICH Guidelines.
- Ability to work effectively with global teams and lead initiatives across different geographies.
- Strategic leadership experience, including team development and process improvement.
- Familiarity with clinical development IT solutions and experience creating and implementing SOPs.
This role includes supervisory responsibilities.