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Executive Medical Director/ VP Clinical Development - Heme
150928
Posted:
25/09/2024th
25/09/2024
- 308000 USD - 420000 USD
- Emeryville, United States
- Permanent
The Executive Medical Director will be responsible for leading clinical development initiatives within the Hematology portfolio, overseeing both early and late-stage programs. This role requires close collaboration with internal teams, external partners, and vendors, with an emphasis on developing strategies and ensuring project deliverables are met on time and within budget. Reporting to the VP of Clinical Development for Hematology, the Executive Medical Director will contribute to shaping and executing clinical research strategies, while building and refining best-in-class global capabilities. This role also involves cross-functional collaboration across clinical development, operations, regulatory, safety, and translational research teams.
Key Responsibilities:
- Craft and oversee clinical trial protocols, amendments, and related documents.
- Manage the creation of informed consent forms and Investigator Brochures.
- Lead the drafting and review of clinical study reports, manuscripts, posters, and abstracts.
- Contribute to clinical components of regulatory submissions (e.g., INDs, NDAs), and key regulatory documents such as Developmental Safety Update Reports and Health Authority Briefing Documents.
- Analyze risks and benefits for applicable documents.
- Develop comprehensive Clinical Development Plans.
- Partner with operational teams to support the effective planning and execution of clinical trials.
- Serve as a scientific and medical resource during the conduct of clinical studies, providing responses to queries from research sites, ethics committees, and regulatory authorities.
- Analyze and interpret clinical trial data, presenting findings internally and externally as needed.
- Represent clinical programs or studies in internal and external meetings and cross-functional teams.
- Develop slide decks and presentations for both internal leadership and external partners.
- Build and maintain relationships with key opinion leaders and investigators.
- Organize and lead advisory boards and investigator meetings.
- Conduct therapeutic area and competitor research, providing insights and analysis.
- Foster collaboration with internal teams and identify opportunities for continuous improvement in processes.
- Contribute to resource planning, budgeting, and organizational development.
- Ensure compliance with internal and external standards and regulations.
Qualifications:
- Medical Doctor (MD or equivalent) with specialization in Hematology/Oncology preferred.
- At least 8 years of experience in the pharmaceutical or biotechnology industry, or relevant academic background.
- Proven experience managing all phases of clinical trials, from study initiation through to reporting.
- Oncology experience is highly desirable, though exceptional candidates from other therapeutic areas will also be considered.
- Strong understanding of the global clinical development process, including trial design and regulatory pathways.
- Excellent verbal and written communication, as well as strong organizational and leadership skills.
- Knowledge of GCP, ICH guidelines, and relevant industry regulations.
- Demonstrated ability to lead in a global, cross-functional environment.
- Prior experience developing and overseeing SOPs and related policies.
- Familiarity with Clinical Development IT systems and solutions.
This position includes team management responsibilities.
Compensation:
The annual salary range for this position is $308,800.00 - $388,800.00. Compensation packages are tailored to the individual, based on skills, experience, education, and geographic location. Eligible roles include participation in performance-based bonuses and long-term incentive programs, with access to comprehensive health, wellness, and retirement benefits.
Thomas Huynh
Resourcer