- Responsible for continued establishment and leadership of effective global healthcare compliance programme.
- Strategic compliance adviser to the Board and management team.
- Lead a team of three Compliance Managers, one for each of IMCR's geographical regions (North America, Europe and Rest of World).
- Senior member of the Legal & Compliance team, a highly visible ambassador for the team and responsible for supporting the General Counsel in managing the team and on ad hoc matters.
- Member of the Immunocore Leadership Team, the senior management body of the company.
- At least 1015 years' experience in healthcare compliance in private practice or in house.
- Comprehensive knowledge of and experience in all US healthcare compliance topics.
- A 'doer' as well as a leader – this is a hands on role.
- A partner to the business in achieving its goals, creative in finding acceptable routes to achieve business goals, able to enforce red lines when required.
- Stimulated by a fastpaced, challenging working environment.
- Experience in an inhouse role, particularly in a growth company.
- Experience of working with regulatory authorities e.g. on an audit or inspection.
- Experience of compliance regimes outside the US, especially in Europe.
- Experience interacting with a management team and / or Board.
- Data protection and / or antibribery experience.
- Strong relationship builder, ability to collaborate effectively with a range of colleagues from different areas of the business.
- Clear, concise, and persuasive verbal and written communication including presentation skills.
- Ability to manage a diverse and demanding workload in a growth company leanresourced environment.
- Resilience, adaptability, strategic thinking, problem solving, implementing solutions to complex issues.
- We lead with science to benefit patients
- We are entrepreneurial
- We value diversity to drive innovation
- We trust and respect each other
- We act with integrity
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VP, Compliance - Rockville, United States - Immunocore Limited
Description
About the CompanyImmunocore (
NASDAQ:
IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers.
We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform.Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.
We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients.
We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity.
We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback.
We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.
Immunocore has one commercial product, KIMMTRAK, which treats a rare form of eye cancer and which was launched in early 2022.
The outgoing CCO has done much of the work to establish an effective compliance programme but the build stage is ongoing as the global launch continues.
Key ResponsibilitiesKey Responsibilities
MAIN PURPOSE OF JOB
KEY RESPONSIBILITIES
Responsible for continued establishment healthcare compliance programme across the group in all geographies with products sold or marketed by any group member as well as any healthcare compliance requirements related to pre-commercial activities (e.g. advisory boards) and locations of offices and headquarters.
The primary initial responsibilities of the job are:1) Continuing to establish, and maintaining, an effective global healthcare compliance programme, to encompass compliance with:
a) Office of the Inspector General (OIG) of the US Department of Health and Human Services (HHS) Compliance Program Guidance for Pharmaceutical Manufacturers (CPG), including US federal healthcare program requirements;
b) The Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals (the PhRMA Code), including certifying and maintaining certification to compliance with the PhRMA Code;
c) US state laws and requirements related to CPG and PhRMA Code compliance;
d) The PhRMA Guiding Principles on Direct to Consumer Advertisements about Prescription Medicines (PhRMA DTC Principles), including certifying and maintaining certification to compliance with the PhRMA DTC Principles; and
e) equivalent requirements for pharmaceutical companies in geographies outside the US based upon the group's current activities in geographies other than US .
2) Regarding the post-holder's responsibility for continuing to establish, and maintaining, an effective compliance programme for the group in respect of its activities outside the US, please note that these activities primarily comprise:
a) for the Europe region, commercialisation via a hybrid model in which in-house personnel are partnered with contracted field-based personnel;
b) for the Rest of World region, commercialisation via a super-distributor arrangement; and
c) limited pre-commercial activities in other jurisdictions.
3) Responsible for price and transparency reporting and signatory of the company's transparency reporting filings. Responsible for the compliance programme in respect of data protection and anti-bribery.
4) Responsible for sourcing and managing outside counsel, ensuring that the company receives high-quality advice on time and on budget.
5) 'Watchdog' role staying connected across the business to identify and anticipate Compliance issues so they can be addressed at the earliest possible time.
6) Lead a team of three Compliance Managers, one for each of IMCR's geographical regions (North America, Europe and Rest of World).
The N America Manager also leads on price and transparency reporting, the Europe Manager on data protection and the Rest of World Manager on Anti-Bribery.
7) The post-holder will also be a senior member of the Legal & Compliance team (12 heads – GC, VP Legal – Healthcare, IP x2, Contracts x4, Compliance x4), a highly visible ambassador for the team and responsible for supporting the General Counsel in managing the team and on ad hoc matters e.g.
8) Member of the Immunocore Leadership Team, the senior management body of the company.
Provide enterprise leadership on cross-functional topics such as strategy, scorecard, budget, cross-functional projects and employee-related matters such as succession planning.
Responsibility for establishing and leading an effective healthcare compliance programme involves:1) engaging employees and directors with the compliance agenda, its strategic importance to the business and its relationship to our values and goals;
2) design (where required) and continuous improvement of an effective global healthcare compliance programme, involving:
a)
Policies and procedures:
Designing and maintaining a suite of policies and procedures suitable for a global, commercial-stage biotech;
b)
Compliance Committees:
Leadership of Board and management Compliance Committees, membership of other compliance-related committees e.g. Grants & Donations Committee;
c)
Training:
Design and maintain an effective training programme, and work with group's Quality function to develop and maintain associated records;
d)
Communication:
Maintaining effective lines of communication between employees and postholder, and postholder and management / Board, key internal contact for relevant compliance complaints and matters;
e)
Monitor / Audit:
Design and maintain plan to monitor levels of compliance and seek opportunities for improvement, including outsourced elements of the compliance programme (e.g. US government rebate reporting), and develop and coordinate appropriate auditing plan;
f)
Enforcement:
Develop and maintain plan to enforce standards (e.g. via contractual or disciplinary measures) and work with group's HR function; and
g)
Investigations:
Investigating possible compliance issues, including, where necessary, independently investigating and acting on matters related to compliance, such as by designing and coordinating: internal investigations (e.g. responding to reports of problems or suspected violations), any resulting corrective action (e.g. making necessary improvements to policies and practices, and working with appropriate functions on taking appropriate disciplinary actions). The CCO has independent authority to pursue investigations including independent authority to engage outside counsel if required.
3) coordinating with appropriate personnel to ensure that the List of Excluded Individuals / Entities has been checked with respect to all employees and independent contractors;
4) operational work related to implementation of effective healthcare compliance programme, such as reviewing promotional / pre-promotional materials and agreements concerning dealings with Healthcare Professionals (HCPs) etc; and
5) participating with the company's counsel in the appropriate reporting of any self-discovered violations of US federal healthcare program requirements.
The postholder will be responsible for identifying and connecting with appropriate networks and resources for leaders of global healthcare compliance programmes at pharma / biotech companies.
PERSON SPECIFICATION
Experience & knowledge
Essential
Bachelor's degree required. Law degree and / or compliance certification preferred.
COMPETENCIES
IMMUNOCORE VALUES
