Senior Director, Clinical Operations

Role Summary:

The Senior Director, Clinical Operations is a pivotal role responsible for executing the clinical operational strategy to ensure that all clinical development activities within the company are conducted efficiently to agreed corporate timelines and in compliance with local and global requirements. You will support the clinical team with the implementation and oversight of clinical trials, focusing on the areas of clinical operational strategy, trial logistics planning, enrollment, site monitoring, data quality, and study reporting. This role will be the critical interface between Sponsor, CRO, and team at study sites.

Key Responsibilities:

• Direct input into the clinical operational strategy and plans.
• Implementation and management of the clinical operational plans and programs in order to meet corporate goals and objectives.
• Work with Clinical Development to draft clinical trial protocols and other trial-related documents, and work with other departments and functions to implement clinical trial protocols. 
• Serve as an interface with clinical investigators.
• Effectively negotiate contracts with consultants, clinical investigators, and contract research organizations. 
• Conduct funding negotiations with clinical sites when necessary.
• Support the management of site-related activities, development of tracking tools, and manage recruitment timelines.
• Prepare updates on study progress. 
• Prepare the study budgets, and track payment of contracts related to the project.
• Generate clinical department SOPs and conduct trainings as necessary.
• Regularly make presentations to senior staff members and participate in relevant Development Team meetings.
• Procure and oversee outside vendors and consultants as required.
• Supervise and manage activities of clinical operations personnel.
• Ensure familiarity with new developments in disease indications being studied as well as relevant guidelines and regulations pertaining to the conduct of clinical trials.
• Attend scientific and external training meetings as needed.
• Other clinical operations activities as required.

Ideal Candidate:

• Bachelor’s Degree is required.
• A minimum of 8 years of global clinical research experience within the pharmaceutical or biotechnology industry.
• Inflammation and/or Immunology experience is strongly preferred. 
• In-depth understanding and experience across clinical operations with a track record of success in study planning, execution, data cleaning, database locking, study report generation and regulatory inspection. 
• Experience with developing protocols, SOPs, Clinical Study Reports, INDs, NDAs, as well as other clinical, regulatory, and safety documents preferred.
• Ability to lead cross functional study teams in a growing and dynamic organization.
• Excellent communication and interpersonal skills, with the ability to lead and motivate teams and collaborate effectively across functions.

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $255,000 to $285,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.