Director of Risk, Privacy and Compliance

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

• Advance innovative science by pushing boundaries. 

• Bring transformative therapeutics to patients in need.  

• Provide an environment for employees to reach their fullest potential.  

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.

• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.

• Embrace Responsibility. We are humbled by the enormity of our mission.  We hold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.

• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.

• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

Position Summary

The Director, Risk, Privacy and Compliance is an engaged, experienced biopharmaceutical industry professional who will help position AskBio as a leader in the emerging field of gene therapy.  The Director, Risk, Privacy and Compliance will play a lead role in providing risk, privacy and compliance advice and guidance to the global functions of AskBio and its affiliates regarding these topics.

This role, together with other members of AskBio, will maintain effective Risk, Privacy and Compliance Programs that meet or exceed regulatory standards for effective healthcare compliance programs. This individual will be responsible for designing, implementing, and managing risk and compliance policies and procedures, processes, certifications, and disclosures to applicable regulators as well as privacy issues. This position will also lead the training strategy for these areas and will manage the development and implementation of training initiatives. This role advises and supports any investigations to ensure that such investigations are conducted in a timely, objective, and comprehensive manner and appropriate corrective action is implemented in accordance with AskBio’s compliance policies and procedures.

This role may be located in any of our Company’s offices.

Job Responsibilities

• Manage the development and implementation of the risk management and compliance plan designed to evaluate and enhance existing programming to ensure compliance with policies, the laws and regulations and other regulatory guidance

• Responsible for establishing and revising existing policies and procedures to support the work plan

• Oversee the design and implementation of training initiatives for the plan, including live web-based sessions and LMS content. Manage the creation of content and delivery of effective training to new and existing employees

• Advises on and manages the reporting and disclosure obligations under the plan

• Help to lead compliance with data privacy processes and governance in United States to actively help to mitigate data privacy risks, with a focus on those involving HIPAA, clinical trials and other healthcare matters and human resources

•    Partner with Functional Heads and members of the ELT to maintain and enhance a strong culture of risk management and compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem-solving

• Work closely with key stakeholders including Legal, Audit, Human Resources, Finance, Communications, and Safety departments, to ensure effective implementation of initiatives

• Champion an enterprise-wide culture of compliance and business ethics

Minimum Requirements

• Bachelor’s degree from an accredited university and 10+ years’ relevant experience

• 7+ years of pharmaceutical, healthcare or relevant agency experience including prior experience in risk and compliance program management

• Strong business ethics and integrity

• Deep and well-rounded knowledge of applicable federal, state, and local laws and regulations that affect the Company’s Corporate Compliance Program (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code of Conduct, AMA, industry guidance documents, CIA trends, Stark Law, HIPAA, regulations regarding the promotion of marketed products, EFPIA and the False Claims Act, and Anti-Kickback Statutes)

• Experience reviewing and providing counseling regarding federal and state data privacy compliance, HIPAA and associated clauses and agreements

• Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice

• Strong project and time management skills with the ability to handle multiple tasks, set priorities, meet deadlines, and develop process efficiencies where required

• Able to work independently and know when to appropriately escalate an issue for resolution

• Demonstrated experience in handling confidential and sensitive situations and information with ability to exercise a high degree of judgment and discretion

• Demonstrated ability to synthesize information from diverse sources, develop options for resolution, make decisions that are rational and based on sound evidence, and determine an action plan, as needed

Preferred Education, Experience and Skills

• 5+ years’ experience developing and monitoring a risk and corporate compliance program and associated policies, procedures, and training; conducting and resolving internal investigations; and partnering effectively with cross-functional teams to advise on compliance matters and challenges

• Significant experience managing compliance within the context of a CIA and DPA

• Demonstrated leadership skills, including ability to lead change efforts through effective communication and persuasion

• Ability to think critically, strategically and quickly analyze complex compliance circumstances and problems

• Desire to work in a fast paced, science-based biotech setting and be a part of a highly innovative company aimed at transforming the lives of young patients with rare genetic disease

• Ability to work in a dynamic, fast-paced environment with shifting priorities and to interact successfully in a global company with a culturally diverse workforce

• Exceptional written and verbal communication and interpersonal skills

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job‐related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at careers@askbio.com.

Agencies:  Please do not contact any employee at AskBio about this requisition.  Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position.  All agencies must have a prior executed service agreement with AskBio prior to any search engagement.  If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.