Job Title: Chief Medical Officer (CMO)
Location: Boston, MA
Industry: Oncology Biotech
Type: Full-Time, Executive Level
Company Overview:
We are a cutting-edge biotechnology company based in Boston, focused on pioneering innovative therapies for cancer treatment. Our mission is to transform oncology care through the development of targeted, personalized therapies. We are seeking a highly experienced and visionary Chief Medical Officer (CMO) to join our executive team and drive the clinical strategy for our oncology programs.
Position Overview:
The Chief Medical Officer (CMO) will be responsible for leading the overall clinical development and regulatory strategy for our oncology pipeline. This role will work closely with the CEO, CSO, and other executive leadership to ensure alignment of clinical objectives with the company’s strategic goals. The CMO will oversee all aspects of clinical operations, including clinical trial design, implementation, and regulatory compliance, while ensuring the highest standards of patient care and safety.
Key Responsibilities:
Clinical Strategy & Leadership:
- Lead the development and execution of clinical strategies for the company’s oncology programs.
- Collaborate with R&D, regulatory, and commercial teams to align clinical goals with corporate objectives.
- Provide medical and scientific leadership across all clinical development activities, including preclinical-to-clinical transitions, clinical trials, and regulatory submissions.
Clinical Trial Oversight:
- Oversee the design, planning, and execution of Phase I-IV clinical trials, including patient recruitment, data collection, and outcome assessment.
- Ensure that all clinical trials are conducted in compliance with regulatory standards, including FDA, EMA, and ICH guidelines.
- Monitor trial progress and ensure high-quality data generation and timely delivery of key milestones.
Regulatory & Compliance:
- Lead the preparation and submission of clinical and regulatory documents, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Biologics License Applications (BLA).
- Serve as the primary medical liaison with regulatory agencies, including the FDA, EMA, and other global health authorities.
- Ensure the company adheres to ethical and legal standards in clinical research and drug development.
Patient Safety & Medical Monitoring:
- Provide oversight of patient safety and risk management in clinical trials, ensuring adherence to pharmacovigilance protocols.
- Serve as the primary point of contact for medical monitoring during trials and post-market safety assessments.
Collaboration & Stakeholder Engagement:
- Collaborate with internal teams, Key Opinion Leaders (KOLs), academic institutions, and external partners to advance clinical programs.
- Engage with the oncology community and patient advocacy groups to ensure alignment of clinical programs with patient needs.
Team Leadership & Development:
- Lead and mentor a multidisciplinary team of clinical, regulatory, and medical professionals.
- Build and manage relationships with Contract Research Organizations (CROs) and other external clinical partners.
Qualifications:
Education:
- MD required, with board certification in oncology or a related field (medical oncology, hematology-oncology preferred).
- Advanced training in clinical research or drug development is a plus.
Experience:
- 10+ years of clinical development experience in oncology, with a track record of success in leading clinical trials from Phase I-IV.
- Previous CMO or senior medical leadership experience in a biotech, pharmaceutical, or academic setting focused on oncology.
- Extensive experience in regulatory interactions with the FDA, EMA, and other global health authorities.
Skills & Competencies:
- In-depth knowledge of clinical trial design, oncology therapeutic development, and regulatory requirements.
- Strong leadership, decision-making, and strategic thinking skills.
- Excellent communication and presentation skills, with the ability to convey complex clinical information to both scientific and non-scientific audiences.
- Proven ability to work in a dynamic, fast-paced environment and lead cross-functional teams.
Benefits & Compensation:
- Competitive salary and executive bonus structure.
- Equity participation.
- Comprehensive healthcare benefits.
- Opportunity to drive the development of breakthrough therapies in oncology.
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