Senior Director Corporate Compliance
The role will include (but is not limited to): managing the teams, setting and developing policies, managing training, overseeing and implementing compliance requirements, working with compliance vendors, monitoring and managing the privacy reporting obligations, policies and processes, managing the EH&S teams globally.
Annually: USD 0 - 0
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Philadelphia, Pennsylvania, United States
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
We are looking for an energetic, pragmatic and experienced individual to lead our corporate compliance team and oversee compliance within our organisation.
This role is a senior role within the organisation and will head up the corporate compliance teams including global privacy, EH&S and HTA as we head towards the filing of our first BLA. The role will include (but is not limited to): managing the teams, setting and developing policies, managing training, overseeing and implementing compliance requirements, working with compliance vendors, monitoring and managing the privacy reporting obligations, policies and processes, managing the EH&S teams globally. This person will be responsible for managing the processes and controls required for compliance with various national laws and regulations and industry best practices. This individual will be a key business liaison to all business functions on compliance operational issues.
- Report to SVP, General Counsel and serve as head of compliance operations for employees globally.
- Partner with commercial team to put in place compliance policies and mechanism ahead of commercial launch of first product.
- Oversee compliance within the organisation, assisting Compliance Officer
- Manage privacy policies and documentation, reporting into data controller, SVP
- Assist with managing global transparency reporting including the timely and accurate data submissions for Open Payments, state disclosure law reports, and global requirements as needed.
- Assist with the design and manage the execution of compliance auditing and monitoring programs.
- Set up, design and implement effective and efficient communication tools.
- Maintain and manage employee, third-party vendor, and new hire compliance training.
- Manage compliance budget and compliance consultant arrangements.
- Manage global EH&S team to provide EH&S advice and support across business.
- Stay abreast of industry law changes and inform the business.
QUALIFICATIONS & EXPERIENCE
- Strong academics required. Minimum of a bachelor’s degree in a related field required.
- Demonstrable experience in providing compliance advice to pharmaceutical/biotech companies and managing compliance function, or in a similar role at a pharmaceutical/biotech company.
- Knowledgeable of healthcare compliance requirements, particularly U.S. laws and regulations, OIG guidance, transparency requirements, and applicable industry codes.
- JD or law degree or equivalent preferred
- Previous experience in the biopharmaceutical industry, particularly in the immunotherapy field
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
6 months ago