We're Hiring: Clinical Scientist (Hybrid | Cambridge, MA)

We're excited to share details about an upcoming Clinical Scientist opportunity that will soon be available. While this role is not yet open yet, please apply to be considered when available.

Are you ready to take on a pivotal role in advancing treatments for chronic inflammatory demyelinating polyneuropathy (CIDP)? We're looking for a Clinical Scientist to join our team and support a global clinical program encompassing one phase 2 trial, two core phase 3 trials, and a phase 3 long-term safety (LTS) trial, across 100 sites globally.

Position Details:

• One year contract
• Shift: Monday-Friday, 8:00 AM-5:00 PM EST, with flexibility.
• Hybrid Work: Minimum 2 days onsite (with flexibility for business needs).
• Location: Open to candidates willing to relocate at their own expense.
• Parking: Paid parking is required onsite (details in the playbook).

Key Responsibilities:

Collaboration:

• Work closely with two Medical Directors and another Clinical Scientist to ensure seamless operations.
• Meet with Medical Directors 2-3 times weekly to review trial data and address action items.
• Act as a liaison between study teams, investigators, and regulatory authorities.

Data & Medical Monitoring:

• Conduct ongoing data reviews, including adverse event reporting, deviations, and validation activities.
• Perform centralized monitoring and clinical case reviews, ensuring consistency and accuracy.

Document Preparation:

• Draft and review study-related documents, including protocols, protocol amendments, informed consents, study plans, and charters.
• Assist in the development and validation of CRFs (Case Report Forms) to align with protocols.

Study Support:

• Provide scientific input during study startup, ongoing trials, and closeout activities.
• Support the preparation of responses for ethics committees, investigators, and regulatory queries.

Committee Management:

• Organize and lead steering committees, data monitoring committees (DMCs), and adjudication committee meetings.
• Draft and finalize meeting minutes, ensuring timely follow-up on action items.

Regulatory & Safety:

• Assist in the preparation of regulatory submission portfolios.
• Support pharmacovigilance teams by validating safety event cases, particularly adverse events of special interest.

Required Skills & Qualifications:

Education:

• Ph.D., Pharm.D., or equivalent advanced degree in a related field.
• Bachelor’s degree considered for candidates with extensive experience.

Experience:

• Minimum 5 years in clinical research or drug development.
• Expertise in late-stage clinical trials, medical monitoring, and data reviews.
• Proficiency in reviewing and managing quality deviations, protocols, and consents.
• Hands-on experience with medical validations and adverse event reviews.

Technical Skills:

• Strong understanding of data collection, flow, and validation processes.
• Familiarity with digital tools for data tracking and reporting.

Soft Skills:

• Detail-oriented with excellent organizational skills.
• Effective communicator with strong verbal and written abilities.
• Ability to work autonomously and synthesize complex information for diverse stakeholders.

Preferred Qualifications:

Industry Experience:

• Background in neurology or neuroscience.
• Experience in medical writing (e.g., drafting protocols or consents).
• Familiarity with medical safety processes.

Additional Expertise:

• Knowledge of centralized monitoring strategies.
• Previous involvement in data-driven and risk management approaches.

Interview Process:

• Virtual: Initial and follow-up interviews conducted online.

Ready to join a global team driving innovation in clinical research?

Apply today to play a crucial role in advancing groundbreaking therapies in neurology!

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