Associate Director, Compliance
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Overview
Job Description
Who We Are:
Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.
The Role:
Cogent Biosciences is preparing for its first commercial launch and we’re seeking a motivated compliance professional to join our growing team. The Associate Director, Compliance will be responsible for leading transparency reporting, supporting the development and execution of our risk assessment and monitoring plans, developing data analytics and dashboards, and providing support for compliance-related projects. This is an exciting opportunity to build out a developing compliance program and add value in a meaningful way.
Responsibilities:
Transparency
- Serve as subject matter expert on aggregate spend and global reporting requirements, staying abreast of applicable transparency related laws, codes, and regulations.
- Lead transparency data collection, validation, and management of the Company’s third-party data aggregation partner to ensure accurate and timely reporting in accordance with applicable laws and industry codes.
- Train third-party vendors on transparency data collection practices.
- Lead the development, implementation, and continuous improvement of transparency related trainings, processes, and work instructions.
Risk Assessment and Monitoring
- Support compliance risk assessment, including mitigation planning and execution to ensure the effectiveness of the Company’s compliance program.
- Assist in the development and execution of the Company’s annual monitoring plan.
- Conduct both live and desktop monitoring of business activities to ensure compliance with applicable laws, regulations, and Company policies.
Data Analytics, Dashboards and Reporting
- Develop and maintain compliance data analytics and dashboards to support ongoing monitoring.
- Prepare presentations and reports summarizing compliance activities, findings and trends.
Qualifications:
- A./B.S. degree or equivalent required; relevant additional certifications a plus.
- 7+ years of experience in compliance within biotech/pharma.
- Strong experience with transparency reporting requirements and related laws and codes.
- Strong data analysis and reporting skills.
- Demonstrated attention to detail and high-quality work product.
- Strong interpersonal skills, including proven ability to interact and communicate effectively with individuals from multiple departments at varying levels of the organization.
- Commitment to professionalism and ethical conduct, including ability to handle confidential and/or sensitive information.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Knowledge of applicable healthcare compliance laws, regulations and industry codes.
- Ability to manage multiple priorities and work collaboratively across teams.
- Ability to travel up to 10%.
Salary Range:
$180,000 - 210,00 USD
Waltham, MA: Our headquarters is located in the Greater Boston life sciencescommunity, with an open, collaborative office environment designedto support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.
Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline.
Our Offer To You
At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart.We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 401(k) match with immediate vesting, generous paid time off, 12 weeks of fully paid parental leave, paid family and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up to 20 weeks.Additionalperks likewellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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