What You’ll Do:

The Director, Clinical Scientist is a senior, hands-on scientific leader responsible for the scientific execution of clinical trials. This role partners closely with Clinical Operations and cross-functional teams to ensure high-quality trial conduct, rigorous data review, and clear scientific communication from study start-up through reporting.

This position requires deep clinical trial experience, strong organizational skills, and comfort working directly in trial data. An MD is not required for this role.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Support the Medical lead for one or more Phase I–III clinical studies
• Support studies across the full trial lifecycle, from start-up through database lock and reporting
• Lead ongoing review of clinical trial data listings, including adverse events, laboratory data, concomitant medications, vitals, ECGs, and safety outputs
• Identify data trends, inconsistencies, and potential issues; partner with Data Management, Biostatistics, and Safety to resolve them
• Act as a close scientific partner to Clinical Operations to deliver on trial execution
• Collaborate effectively with cross-functional teams including Clinical Operations, Data Management, Biostatistics, Programming, Safety, and Regulatory
• Author, review, and contribute to trial documents, such as protocols, amendments, Investigator’s Brochures, and Clinical Study Reports
• Develop and deliver clear, well-structured presentations to study teams and internal leadership
• Drive execution, follow-through, and accountability across multiple concurrent deliverables
• Be flexible with travel and attend site related clinical development activities; form and maintain relationships with KOL’s

Required Qualifications:

• 8+ years of extensive hands-on experience supporting clinical trials in a clinical development role
• Demonstrated experience reviewing and interpreting clinical trial data listings
• Strong understanding of clinical trial conduct and cross-functional trial workflows
• Proven ability to partner effectively with Clinical Operations
• Exceptional organizational, prioritization, and execution skills
• Strong written and verbal communication skills
• 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

Education:

• Advanced degree in life sciences discipline (PhD, PharmD, MS, or equivalent)

What You’ll Do:

We are seeking an experienced, highly motivated 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 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
• Serve 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
• Partner 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:

• 3+ 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