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BigHat Biosciences — Waltham Massachusetts
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.
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%.
Qualifications
S. degree or equivalent required; relevant additional certifications a plus. 7+ years of experience in compliance within biotech/pharma.
Compensation
will vary based on skills, experience, and location. Our Locations Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open , collaborative office environment designed to support teamwork and connection.