We are seeking an experienced, highly motivated Senior Medical Director, Clinical Development to join our growing team. This individual will play a pivotal role in designing and executing clinical development programs that advance our pipeline of innovative therapeutics. The successful candidate will bring strong clinical insight, a deep understanding of drug development in a biotech setting, and a proven ability to work cross-functionally in a dynamic, fast-paced environment.
Required location: Waltham, MA (hub-based, onsite 3-4 days per week)
Responsibilities:- Responsible for medical monitoring/reporting and safety activities
- Provide strategic medical leadership in the design, planning, and execution of clinical development strategies across multiple studies
- Acts as the medical contact at the company for clinical/medical issues
- Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel
- Serves as the medical expert for assigned assets studies
- Contribute to regulatory interactions and strategy, including IND/CTA submissions and briefing packages
- Collaborate and work closely with Clinical Operations to ensure appropriate site selection, patient recruitment strategies, and high-quality trial execution
- Oversee and support data interpretation, analysis, and clinical study reports
- Work closely with internal stakeholders, including Regulatory, Safety, CMC, Medical Affairs, and Translational Science teams
- Drive partnerships with external collaborators, KOLs, CROs, and investigators
- Support scientific publications, conference presentations, and other external communications
- Participate in safety review meetings and provide clinical input into adverse event evaluation and reporting
Required Qualifications:- 4+ years of industry experience in clinical development, preferably in a biotech or small pharma environment
- Hands-on experience designing and executing clinical trials
- Understanding of GCP, clinical trial design, regulatory requirements, and safety monitoring
- Excellent written and verbal communication skills, including protocol and regulatory document writing
- Demonstrated ability to engage with KOLs, investigators, and cross-functional teams
- Can work independently; self-starter attitude
- Advanced PowerPoint skills; working knowledge of Excel and other commonly used clinical systems/tools
- Ability to manage multiple studies and deadlines in a fast-paced environment
- Must be exceptionally detail oriented
Preferred Qualifications:- Experience in cardiometabolic therapeutic area is advantageous
- Proven track record of contributing to IND submissions and global regulatory filings is a strong plus
Education:- MD or equivalent is required
Salary Range
$296,000-$355,000 USD
For Full Time Roles: This range represents the company's good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.
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