Job Details
Job Details: Senior Director, Legal Healthcare
Full details of the job.
Vacancy Name
Vacancy Name Senior Director, Legal Healthcare
Vacancy No
Vacancy No VN290
Employment Type
Employment Type Full Time
Location of role
Location of role Conshohocken
About the Company
About the Company Immunocore (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. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. 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.
Key Responsibilities
Key Responsibilities MAIN PURPOSE OF JOB
- Responsible for providing healthcare-sector specific legal advice in our commercial-stage, global biotech.
- 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.
KEY RESPONSIBILITIES
Responsible for providing healthcare-specific legal advice in our commercial-stage, global biotech. The post-holder will be the Legal lead on matters related to medical product development and commercialisation, including:
1) Clinical trial matters including:
a) Contractual queries escalated from Contract Managers negotiating Clinical Trial Agreements
b) Legally sensitive topics on clinical trials e.g. patient recruitment and compensation, HIPAA
2) Medical Affairs matters including:
a) Grants & Donations
b) Advocacy
c) Behaviour standards for MSLs
d) Legal review of non-promotional and scientific materials
3) Manufacturing matters including contractual queries escalated from Contract Managers negotiating agreements for outsourced manufacturing
4) Commercial matters including:
a) Price making and price reporting
b) Patient Assistance Programme
c) Named Patient / Expanded Access Supply
d) Product liability
e) Government interactions / lobbying
f) Behaviour standards for the sales force
g) Legal review of product and patient materials
5) Business Development matters including:
a) Collaborations
b) Acquisitions
6) Communications matters including Legal review of website and press releases and social media posts (except for SEC compliance)
7) Healthcare Compliance programme matters, including interpretation of OIG and related guidance and enforcement (there is a separate VP for Ethics and Compliance)
The post-holder will also have responsibility for sourcing and managing outside counsel, ensuring that the company receives high-quality advice on time and on budget.
The post-holder will also have a watchdog role staying connected across the business to identify and anticipate Legal issues so they can be addressed at the earliest possible time.
The post-holder will also be a senior member of the Legal & Compliance team (12 heads GC, this post, 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. team meetings, budget, deputising for the General Counsel where appropriate.
PERSON SPECIFICATION
Experience & knowledge
Essential
- At least 10-15 years experience in healthcare law in private practice, in house or at a regulator.
- Comprehensive knowledge of and experience in all US healthcare law topics.
- A do-er 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 fast-paced, challenging working environment.
Desirable
- Experience in an in-house role, particularly in a global, growth company.
- Experience outside the US, especially in Europe.
- Experience interacting with a management team and / or Board.
Education & qualifications
Qualified attorney
COMPETENCIES
- 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 lean-resourced environment.
- Resilience, adaptability, strategic thinking, problem solving, implementing solutions to complex issues.
IMMUNOCORE VALUES
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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