SU2C Director of Compliance: works under the direction of the Chief Scientific Administrative Officer (CSAO) to provide leadership in planning, developing and implementing of SU2C’s compliance program which includes key policies and procedures in relation to SU2C’s management and adherence to compliance, ethics, safety , legal and regulatory standards for SU2C and all funded projects. These compliance related-matters include but are not limited to Conflicts of Interest and Commitment, Transfers of Value, Confidentiality, Non-Disclosure, Research Ethics, Data Security, Privacy, Export Controls, Human Subjects, Animal Care and Welfare, HIPAA, Laboratory Safety, Good Clinical Practice (GCP), Anti-bribery and Anti-corruption, and other relevant regulations. SU2C is looking for an energetic, go-getter with strong compliance experience in healthcare/science/non-profit sectors. This critical position carries a high degree of visibility and requires close collaboration with team members across SU2C along with external partners. The SU2C Director of Compliance is a passionate, ambitious, professional who can deliver results in an organization and a fast-paced environment. This position will often represent SU2C in managing compliance and work with CSAO on other contract and grants administration and management related matters.
- Manages overall compliance-related matters for SU2C, along with grants and awards managed internally and SU2C grants and awards by AACR.
- Develop and improve on SU2C compliance program, including all needed components such as policies and procedures, training, communication, investigations, monitoring and annual review and assessment. Provide expertise in developing and implementing the program, and incorporating best practices into SU2C, and the research and grants management system.
- Interfaces with key internal staff and external constituents on behalf of the CSAO Represents the SU2C in meetings with key personnel as it relates to compliance-related matters.
- Manages all regulatory, internal, and external disclosure and reporting process and follow-up on required management plans including but not limited to Conflicts of Interest and Commitment, Confidentiality, Non-Disclosure Agreements, Data Privacy, Security, HIPAA and GCP Compliance, and any other regulatory requirements as needed.
- Responsible for the gathering accurate data and filing of required regulatory reporting including by not limited to the Sunshine Act and any other transfer of value reporting requirements.
- Maintaining organizational records related to SU2C agreements, amendments, compliance related disclosures, policies and matters.
- Work with CSAO and SU2C Leadership as key personnel with appropriate legal counsel in relation to developing internal plans or responses related to compliance breaches and action plans.
- Facilitate and manage the process of identifying, prioritizing, chartering, communicating, and managing key organizational-level compliance projects to ensure the objectives and operational efficiencies are achieved.
- Work closely with external SU2C scientific grants administration organizations to provide oversight and ensure that there is proper alignment and coherence related to compliance across all of SU2C grant mechanisms.
- Work closely with the CSAO and appropriate legal counsel as needed on review of grant agreements and the negotiation process.
- Disseminates information from the SU2C President and CEO to the staff and external audiences in a clear, concise, open and transparent manner. Follows up with key contacts through written and verbal communications. Responds to and/or escalates issues as they arise with various compliance related matters.
- Researches and identifies national and international compliance trends relevant to SU2C and communicates to leadership at SU2C to anticipate future issues that may arise to ensure success of the program and its goals.
- Monitors trends, researches appropriate subject matter, new technology and assimilates this information into appropriate proposal and summaries for leadership.
- Plan and develop content-related to compliance matters for departmental meetings including staff meetings.
- Proactively schedules and conducts internal and external meetings as needed.
- Must be able to travel over 25%, at times with short notice.
- Other duties may be assigned
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
- Minimum of 10 years’ experience building and managing compliance programs for higher education institution, government agency or non-profit, preferably in biotech, pharma, or a cancer research organization (CRO)
- Advanced degree (MBA, JD, PhD, MD) is required, JD is preferred.
- Clinically oriented or scientific research administration training and experience in clinical trials research.
- Must have working knowledge of relevant compliance topics, such as Good Clinical Practice (GCP) guidelines, HIPAA, and other relevant regulatory schemes relevant for SU2C.
- Demonstrated expertise working with compliance programs at a tier one research institution, scientific funder, and/or government agency, including experience with contracts and grants administration.
- Certification in research administration or research compliance a plus.
Language Skills: Proficiency in the English Language and excellent verbal and written communication skills in addition to the ability to present sensitive issues with a high level of tact, diplomacy and integrity.
Other Skills and Abilities:
- A strategic thinker and creative problem solver with strong analytical skills.
- Excellent judgment and ability to grasp complex subject matter and communicate with all levels of employees.
- Able to facilitate meetings and communicate results to executive team and management.
- A demonstrated ability and gravitas to work with a wide variety of skillsets and personalities to move the ball forward.
- A fast learner who can master the salient details of research administration and compliance and apply that knowledge.
- Success and high comfort level with facilitating discussions between multiple stakeholders with multiple opinions and experiences.
- Must be articulate and display clear and dynamic communications skills- oral, written and presentation.
- A sophisticated understanding of the interrelations amongst all of the parties involved.
- An in-depth understanding of various issues within the scientific and corporate business community, including funding, both public and private.
- Strong interpersonal skills, able to work collaboratively with multiple constituents.
SUPERVISORY RESPONSIBILITIES: Carries out supervisory duties in accordance with federal and state law and company policy.
- Directly: N/A Indirectly: N/A
Possess Physical Ability to:
- Sit for extended periods of time.
- Operate a motor vehicle.
- Lift & carry files or boxes, file & retrieve documents
- To lift boxes less than 150 pounds in weight