- Drive Clinical Trial Success: Collaborate with senior leadership to craft key clinical documents (protocols, IBs, INDs), providing insights on operational feasibility and logistical considerations.
- Lead Cross-Functional Partnerships: Forge strong relationships with investigators, site staff, and CROs, effectively communicating complex scientific concepts while overseeing operational strategies for achieving program goals.
- Champion Operational Excellence: Manage all vendor relationships, from budget negotiations to issue escalation, ensuring exceptional work quality, timelines, and budget adherence.
- Proactively Manage Risk: Develop and execute operational risk management strategies in collaboration with the Sr. Director of Clinical Development.
- Safeguard Patient Safety: Oversee the timely capture, reporting, and evaluation of adverse events and product safety issues.
- Promote Data-Driven Decision Making: Develop and implement reporting standards for study progress metrics, providing timely data for comprehensive clinical study reports.
- Ensure Meticulous Documentation: Oversee clinical and regulatory files, including the essential Trial Master File (TMF).
- At least 7 years of experience in the biopharma or CRO industry is required
- Preferably some experience in managing clinical sites
- Demonstrated excellence in managing clinical trials and a solid understanding of the trial processes
- Proven track record of success and a history of innovative program and trial execution to ensure study progress, timelines, data integrity, and compliance with health authority requirements
- Domain expertise in oncology drug development, with a preference for experience in early-stage clinical trials
- Strong and up-to-date knowledge of Good Clinical Practices and ICH Guidelines, including their application in the conduct of clinical trials
- Highly competitive and inclusive medical, dental and vision coverage options
- BCBS PPO and PPO HSA plans
- BCBS Dental Plan
- EyeMed Vision Plan
- FSA and HSA for medical expenses and dependent care expenses
- 401(k) Program via Fidelity with the company match
- Corporate Wellness Program
- Unlimited Paid Time Off policy
- Winter shut down
- 12 weeks of 100% paid parental leave for birthing/primary parent and primary guardian in case of adoption and 3 weeks of 100% paid parental leave for non-birthing/non-primary parent/guardian.
- Paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Free parking, subsidized commuter passes, or a $100 monthly stipend for walking/biking to work
- Company lunches on Wednesdays
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Director, Clinical Operations - Cambridge, United States - Foghorn Therapeutics
Description
Job Description
Job DescriptionOur Culture: Why work with us?
At Foghorn Therapeutics, we believe in "People First, Mission Always."
We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics – demonstrated by our community speaking more than 22 languages and representing over 24 nationalities. We value our teammates as people, not just as employees – validated by our actions that let our people know that we care about them, their families, and their lives.
We say "Mission Always" because we know a relentless commitment to our mission will make a difference in the lives of others. We believe our success will come from evaluating the data to follow the science. We work hard to develop a new class of therapies that could improve the lives of over 2.5 million people with cancer.
Our culture is focused on succeeding through the evaluation of data, not people. And in that, relationships can flourish and develop.
Our Science:
The groundbreaking science behind our therapies continues to yield vital insights into diseases that have confounded physicians and researchers. Our core scientific approach is centered on the chromatin regulatory system, which opens and closes the right sections of DNA at the right time. Breakdowns in the chromatin regulatory system lead to a wide range of diseases, including cancer, impacting millions of people.
Our proprietary Gene Traffic Control platform is a powerful tool for understanding and modulating the chromatin regulatory system. We are pursuing multiple treatments for breakdowns in this system. We are the only company with the ability to study and target the chromatin regulatory system at scale, in context, and in an integrated way.
The Role:
As the Director of Clinical Operations at Foghorn, you will play a pivotal role in driving the success of critical clinical programs. You'll provide strategic leadership and operational expertise to guide our Clinical Development team, ensuring the seamless execution of clinical trials. In this role, you'll collaborate across diverse functions to develop operational strategies, support key initiatives, and promote timely, on-budget trial completion that adheres to the highest quality standards.
In This Role, You'll Get To:
Requirements
About you:
Benefits
Foghorn Therapeutics is pleased to provide you and your family with a comprehensive suite of benefits, including:
Foghorn Therapeutics is a smoke-free, alcohol-free and drug-free work environment.
Foghorn is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Foghorn Therapeutics will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
