Head Corporate Compliance

We are⠀looking⠀for an⠀energetic,⠀commonsensical⠀and⠀experienced⠀individual⠀to lead⠀our⠀corporate⠀compliance⠀team and⠀oversee⠀and manage⠀compliance⠀within our⠀organization.

Reporting⠀to the⠀Chief⠀Legal &⠀Compliance⠀Officer,⠀this⠀position⠀will be⠀responsible⠀for⠀implementation⠀and⠀oversight⠀of⠀ADCT’s⠀global⠀corporate⠀compliance⠀program⠀including⠀healthcare⠀compliance⠀and⠀transparency⠀reporting.⠀The⠀incumbent⠀in this⠀role will⠀be⠀required⠀to assess⠀compliance,⠀business,⠀and⠀implementation⠀risk and⠀advise on⠀a path⠀forward⠀which⠀supports⠀business⠀objectives⠀while⠀maintaining⠀the⠀ethical⠀and⠀compliance⠀standards⠀of the⠀Company.⠀This role⠀will⠀support⠀development⠀of written⠀policies⠀and⠀procedures,⠀leading⠀effective⠀compliance⠀training⠀programs,⠀liaising⠀with⠀business⠀partners,⠀developing,⠀and⠀executing⠀monitoring⠀and⠀auditing⠀plans, and⠀assisting⠀with⠀investigation,⠀and⠀overall⠀ownership⠀of the⠀compliance⠀responsibilities.

The⠀role will⠀include⠀(but is⠀not⠀limited⠀to):⠀managing⠀the⠀compliance⠀function⠀at the⠀direction⠀of the⠀CCO,⠀setting⠀and⠀developing⠀policies,⠀managing⠀training,⠀overseeing⠀and⠀implementing⠀compliance⠀requirements,⠀working⠀with⠀compliance⠀vendors,⠀monitoring⠀and⠀auditing⠀compliance⠀programs,⠀policies⠀and⠀processes.⠀This⠀person⠀will be⠀responsible⠀for⠀managing⠀the⠀processes⠀and⠀controls⠀required⠀for⠀compliance⠀and⠀industry⠀best⠀practices.⠀This⠀individual⠀will be a⠀key⠀business⠀liaison to⠀all⠀business⠀functions⠀on⠀compliance⠀operational⠀issues.

While⠀the team⠀works⠀primarily⠀remotely,⠀our⠀preference⠀is a⠀candidate⠀who can⠀come to⠀the New⠀Providence,⠀NJ office⠀on a⠀regular⠀basis for⠀in-person⠀meetings⠀and other⠀business⠀needs.

Core Responsibilities:

• With input⠀from the⠀CCO/CLO,⠀lead⠀compliance⠀strategy⠀and⠀operations⠀for the⠀Company.
• Provide⠀leadership⠀and⠀guidance⠀on⠀compliance⠀across⠀business⠀functions.⠀Oversee⠀and manage⠀all⠀compliance⠀related⠀matters⠀within the⠀organization.
• Assist⠀with the⠀design and⠀manage the⠀execution⠀of⠀compliance⠀auditing⠀and⠀monitoring⠀programs,⠀investigations⠀frameworks⠀and⠀practices,⠀enforcement⠀and⠀discipline⠀as well as⠀risk⠀response⠀and⠀prevention⠀practices.
• Work⠀with the⠀Data⠀Privacy⠀Officer to⠀implement,⠀train and⠀oversee⠀privacy⠀policies⠀and⠀documentation.
• Maintain⠀and manage⠀employee,⠀third-party⠀vendor,⠀and new⠀hire⠀compliance⠀training.
• Manage⠀compliance⠀budget and⠀compliance⠀consultant⠀arrangements.

Healthcare Compliance Responsibilities

• Serve as⠀business⠀partner to⠀the⠀commercial⠀and⠀medical⠀affairs⠀organizations,⠀understanding⠀business⠀objectives⠀and⠀advising⠀on⠀effective⠀ways to⠀meet the⠀objectives⠀in a⠀compliant⠀manner.⠀Participate⠀in⠀leadership⠀team⠀meetings.
• Identify⠀potential⠀risk areas⠀and⠀develop⠀plan of⠀action to⠀address,⠀working⠀closely⠀with legal⠀and other⠀functions.
• Develop⠀and⠀implement⠀effective⠀new⠀healthcare⠀compliance⠀policies,⠀procedures,⠀and other⠀resources⠀like job⠀aids.
• Maintain⠀training⠀plan for⠀new⠀commercial⠀and⠀medical⠀affairs⠀employees⠀and a⠀corporate⠀plan for⠀all⠀corporate⠀policies.⠀Assist in⠀the⠀creation⠀and⠀delivery⠀of⠀training⠀content.
• Develop⠀and⠀implement⠀annual⠀communications⠀plan for⠀policies,⠀training⠀and the⠀company⠀hotline.
• Establish⠀and⠀implement⠀auditing⠀and⠀monitoring⠀plan for⠀commercial⠀and⠀medical⠀affairs⠀activities⠀including⠀documentation⠀and⠀supporting⠀system(s).
• Ensure⠀debarment⠀checks⠀occur in a⠀timely⠀manner for⠀all key⠀stakeholders.
• Support/Lead⠀investigations⠀of⠀non-compliance,⠀as⠀requested.
• Evaluate⠀needs⠀assessments⠀for HCP⠀engagement⠀activities.
• Identify⠀continuous⠀improvement⠀opportunities⠀for the⠀ADCT⠀Compliance⠀Program.
• Manage⠀transparency⠀reporting⠀manager,⠀and the⠀filing of⠀federal,⠀state, and⠀country-level⠀transparency⠀reports.
• Perform⠀other⠀compliance-related⠀activities⠀as⠀directed.
• Maintain⠀current⠀understanding⠀of⠀compliance⠀legislation⠀and⠀regulations⠀to ensure⠀adherence⠀to⠀requirements.

Job Requirements:

• Bachelor’s⠀degree⠀required
• JD⠀or law⠀degree or⠀equivalent⠀preferred
• 15+⠀years of⠀relevant⠀healthcare⠀industry⠀experience⠀with a⠀minimum of⠀8 of those⠀years in⠀pharmaceutical,⠀medical⠀device or⠀biotech⠀company;⠀previous⠀compliance⠀officer⠀experience⠀is a⠀plus.
• Experience⠀in⠀building⠀and⠀implementing⠀key⠀components⠀of an⠀effective⠀compliance⠀program,⠀including⠀written⠀standards,⠀training,⠀monitoring⠀and⠀auditing,⠀hotline⠀and⠀investigations.
• Experience⠀in risk⠀assessment,⠀issue⠀spotting,⠀and risk⠀mitigation
• Knowledge/Experience⠀with⠀federal,⠀state, and⠀country-level⠀transparency⠀reporting.
• Ability⠀to⠀establish⠀rapport at⠀all levels⠀of the⠀organization⠀and⠀skilled at⠀navigating⠀conversations⠀with⠀varying⠀opinions.
• Self-motivated,⠀strong⠀project⠀management⠀and⠀decision-making⠀skills
• Ability⠀to stand⠀up to⠀challenges⠀and convey⠀rationale⠀for advice⠀being⠀provided.
• Demonstrated⠀ability to⠀work⠀independently,⠀cross-functionally⠀and⠀collaboratively
• Excellent⠀written⠀and verbal⠀communication⠀skills
• In-depth⠀knowledge⠀of⠀applicable⠀regulatory⠀and⠀compliance⠀requirements⠀(i.e.,⠀FDA, OIG,⠀Anti-Kickback⠀Statute,⠀False⠀Claims,⠀HIPAA,⠀GDPR,⠀FCPA).
• Travel⠀–⠀approximately⠀5% a year⠀- domestic