Executive Medical Director Clinical Development
Greater Boston Area - Hybrid
Compensation: $250,000-290,000 + 25% bonus + Lucrative RSU package
Company Summary:
We have partnered with a mid-sized biotech company at the forefront of developing innovative therapeutic products for endocrine and orphan lung diseases. They already have two key products approved that generated over $200 million in revenue this past year and the have 2 phase 3 studies in development. One of their drugs in development has fast-track designation and given their previous track record of getting pulmonary products approved you can have additional confidence in the efficacy of their science. Their unique delivery method can be used with a variety of drugs, including small molecules and biologics, making it a versatile platform for different therapeutic applications for years to come. If interested in learning more don't hesitate to apply.
Primary Responsibilities:
- Study Execution: Conduct clinical trials in compliance with Good Clinical Practice (GCP) standards.
- Recruitment: Manage and oversee participant recruitment for studies.
- Data Quality: Ensure the highest quality in data generation and collection.
- Compliance: Maintain GCP compliance throughout study activities.
- Medical Monitoring: Provide medical oversight during trials.
- CRO Management: Supervise and collaborate with Contract Research Organizations (CROs).
- Collaboration: Work with Biostatistics and Data Management teams for statistical support and data capturing.
- Safety Oversight: Oversee safety activities across various programs and trials.
- Pharmacovigilance: Assess and report adverse events.
- Logistics: Collaborate closely with Clinical Operations to manage external vendors.
- Regulatory Alignment: Work with Regulatory Affairs to ensure studies meet health authority requirements.
- Quality Assurance: Guarantee health information privacy and data integrity.
- Study Planning:
- Strategic Planning: Assist in planning and executing Phase 1 through 4 clinical trials, including study design and method selection.
- Literature Review: Review relevant literature and consult with internal and external experts.
- Eligibility Criteria: Define participant eligibility criteria and select clinical endpoints.
- Data Evaluation: Utilize mathematical models to evaluate study data and act as the clinical study lead.
- Additional Study-Related Activities:
- Regulatory Documents: Prepare regulatory documents for IND filing, NDA, and collaborate with preclinical research functions.
- Presentations: Prepare and present material for first-in-human committees and study reports.
- Medical Monitoring: Contribute to study medical monitoring in conjunction with CRO medical monitors.
- Data Analysis: Analyze and interpret data, communicating results internally and externally.
- Document Review: Contribute to and review clinical documents such as protocols, study reports, and regulatory submissions.
- Collaboration: Work with Medical Directors, Biostatistics, Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs.
- External Relations: Collaborate with CROs, Principal Investigators, Advisory Boards, key opinion leaders, and regulators.
- Additional Activities:
- Team Representation: Represent Clinical Development on study and project teams, potentially acting as project team leader.
- Senior Management: Present findings and updates to senior management.
- Business Development: Support business development activities, including due diligence.
- Therapeutic Area Support: Provide clinical, medical, and safety support in the endocrinology therapeutic area as needed.
- Other Duties: Perform additional tasks based on organizational needs.
- Perform other duties as assigned.
Ideal Qualifications:
- 3+ years clinical development experience in industry.
- MD or foreign equivalent.
- Pulmonary experience.
