Compliance Monitoring & Risk Management Director

Springworks Therapeutics, Inc. Stamford , CT 06901

Posted 1 month ago

About SpringWorks Therapeutics:

SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.

SpringWorks Leadership Principles:

  • Change Steward
  • Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
  • Excellence Driver
  • Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
  • Growth Coach
  • Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
  • Community Builder
  • Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment

Job Summary:

SpringWorks Therapeutics is a commercial biopharmaceutical company with an approved product in the US Market and key pipeline programs in late-stage development in rare disease and oncology. The Compliance Monitoring & Risk Management Director will report directly to the company's Chief Compliance & Privacy Officer, and will lead the strategy, development, implementation, and management of the organization's Compliance and Monitoring and Risk Management program. The Director will be responsible and work independently to manage all aspect of Compliance and other related internal investigations, reporting, and analytics. The development and management of a robust monitoring and risk management program is a critical aspect of the organization's Compliance and Ethics program and overall governance and culture. The Director will lead the efforts toward continuous improvement and oversee the operations and governance of the Compliance risk management program.

Key Responsibilities:

  • Work with the Chief Compliance and Privacy Officer in setting the strategy for the organization's monitoring and risk management programs for compliance and similar risk related areas.

  • Design, implementation, and management of the company's Healthcare Compliance Monitoring Program.

  • Create, implement, and manage a broad Compliance/Ethics risk management program including conducting risk discussions, and compiling analytics and reporting.

  • Compiling and reporting on Compliance risk assessment activity and working cross-functionally with business on developing mitigation plans, where necessary.

  • Manage the cross-functional investigations process as Compliance Lead including disclosure program, investigative activity, reporting and analytics. Ensuring all compliance concerns or reports of compliance violations are investigated and resolved or properly reported.

  • Manage and enhance compliance operations mechanisms and systems to meet the needs of the company and business objectives, including without limitation, processes for debarment/exclusion screening, Sunshine Act reporting, state compliance reporting, fraud and abuse compliance, auditing / monitoring of healthcare participant-facing field roles, evaluating payments to HCPs against fair market value standards and oversight of the company's compliance hotline.

  • Responsible for Compliance and related operations by ensuring trainings are streamlined to Integrity Works standards, identify potential gaps, and monitor for effectiveness of the training program

  • Create, modify, and implement company compliance risk management processes leveraging technology and systems.

  • Develop risk mitigation strategies and plans and related record-keeping.

  • Design control systems to address cases of violation of Compliance policies.

  • Liaise with other departmental heads for risk management and monitoring discussions

  • Perform other duties and responsibilities as assigned.

Qualifications:

  • Education: Bachelor's degree. Advanced degree in audit, law, business or substantive healthcare area, preferred.

  • 9+ years' experience in international / US healthcare compliance or similar transferrable industry experience such as audit, including material experience in developing and maintaining risk management programs, reporting, data and analytics, and investigative activities.

  • Detailed knowledge of healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, Sunshine Act, FCPA/UKBA, and privacy laws and regulations.

  • Strong technical background in healthcare compliance-related matters arising through the commercialization and marketing of biotechnology/pharmaceutical products.

  • Able to apply knowledge and experience to address issues; able to clearly define issues.

  • Able to effect change while maintaining operating effectiveness; integrates and aligns efforts across business units and functions; monitors results and tackles problems directly.

  • Past success implementing strategic compliance risk management initiatives that align with business goals as well as budgetary realities.

  • Must possess a sense of ownership and responsibility, as well as a proven work ethic delivering excellent work product and exemplary customer service.

  • Demonstrates passion for the business and this role; espouses a collaborative approach; leads by example in setting a positive tone for the compliance function.

  • Demonstrated experience managing compliance professionals

  • Must be able to present to and work effectively with a team.

  • Excellent communicator in both the written and oral form; understands how to approach communication from a strategic perspective.

  • Promotes ideas and new proposals persuasively; shapes stakeholder opinions; works through conflicts and difficult situations; negotiates for win/win solutions.

  • Cultivates internal relationships and relates well to key colleagues at all levels.

  • Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.

  • Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.

  • Ability to travel occasionally including overnight stay driven by business need.

  • This position must be able to work East Coast hours. #LI-Remote

Compensation:

The expected salary range for this position is $170,000 - $220,000. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do - and helps us be healthy, happy, and at our best for the people who need us.

At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group's (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization's DNA.

SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.

This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.

GDPR Statement: When you apply to a job on this site, the personal data contained in your application will be collected by SpringWorks Therapeutics ("Controller"), which is located at 100 Washington Blvd, Stamford CT 6902 and can be contacted by emailing hr@springworkstx.com . Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards under the standard contractual clauses. You can obtain a copy of the standard contractual clauses by contacting us at hr@springworkstx.com.

Your personal data will be retained by Controller for as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.


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Compliance Monitoring & Risk Management Director

Springworks Therapeutics, Inc.