Senior Director, US Compliance Lead at Genmab in Princeton, New Jersey

Job Description:

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.

The Role

The Senior Director, U.S. Compliance Lead has primary responsibility for establishing and maintaining a robust compliance program, initially for evolving commercial organization but potentially extending to enterprise level function in future, aligned to Genmab's values and global standards and consistent with local industry code, best practices, PhRMA Code, and U.S. laws and regulations. This role will be based in Princeton will report directly to the Global Head of Compliance at the Company's Princeton, NJ office.

Responsibilities

Working in close partnership with Business, Legal/other Enabling functions, to include hands-on setting of new U.S. commercial and related compliance program and structures, aligning with global Company values and standards but meeting local needs, standards, and requirements:

U.S. Commercial Compliance Advisory including re:

• Commercial Strategy and Brand Planning, Launch Preparedness; alliance partner engagements on U.S. compliance matters;


• Marketing, Sales, Market Access, Medical compliance support;


• HCP, Patient/ PAG/ HCO Engagement Compliance Lead: Ongoing advisory, consultations on day-to-day business, strategies, plans, mtgs/ other;


• Congress Planning/ Participation


• Medical/ Scientific Grants/ Educational funding, support


• Salesforce and Medical Affairs Field MSL Planning: Call and Incentive Compensation Plan design, Launch meeting support, Compliance SOPs and Trainings (also per below on ongoing basis)


• Reimbursement advice, support

Compliance Leadership/ Governance/ Culture: Charter, set and chair U.S. Compliance/HCC Committee, which may function as adjunct to U.S. LT (TBD); member of U.S. LT; align reporting to global compliance committee and support Board reporting; support and enable robust compliance culture;

Standards, Training, & Communications: Assure timely establishment of high quality compliance-relevant policies, SOPs, Guidance/ FAQs, prioritizing those supporting commercial (medical/sales, marketing, market access, etc.) and assuring alignment to Global Code of Conduct and Global Policies; set training and communications to support rollout ongoing; lead pull-through at local level of core global compliance policies, SOPs, training, tools;

Medical & Promotional Material Reviews/ Promotion Compliance Support: Responsible for setting of promotion, medical, program materials review process and potentially oversight of FDA regulatory submissions process. May also over time have a role in material reviews and approvals, including reviews of promotional, program, and background materials, speaker slides, related materials together with instructions for use of same.

Compliance Advisory to Internal Partners/Customers: Ongoing daily advice to and consultations with business teams, with initial priority focus on Commercial organization;

HCP/ HCO/ Patient Engagements: Ongoing compliance advisory on same plus as to interactions with and support for Patient Advocacy groups business, strategies, brand plans, mtgs/ other;

Environment/ Networking: Routine scans of regulatory, enforcement environment and trade/ business news, other sources for potential Genmab impacts, mitigations; participation in and close networking with key external stakeholders such as trade assocs, government/ agencies/ regional HCC etc authorities, other;

Expertise, Tools, Technology: Enable access to and support use of internal/ external compliance expertise, tools, technology supporting compliant business processes;

Hotline/ Investigations: Manage Compliance Speak Up Hotline reports, investigations, support effective corrective and preventive actions;

Compliance Oversight, Monitoring, Audit & Risk Assessments: Conduct periodic compliance risk assessments, support audits, and assure to assure compliance program effectiveness, understandings; Establish and implement compliance oversight and monitoring programs consistent with local U.S. regulatory requirements and assuring 'lessons learned' framework;

Third Party Compliance Due diligence, Onboarding & Oversight support, as needed;

Federal Sunshine Transparency Reporting and state reporting support;

Compliance Agreement Terms: Support Legal Partners in assuring robust compliance-relevant standard contract terms (e.g. compliance stds/ certifications, ABAC, audit, termination rights, etc.).

Participate as member of Genmab KK Leadership Team (LT): Partner with LT and members to independently and proactively support the U.S. enterprise, including but not limited to the developing commercial team; encourage and support a values-based compliance-intelligent culture across the organization.

Compliance Advisor to U.S. Organization: provide timely, responsive, expert compliance guidance on ongoing basis to support everyday business needs.

Requirements

• Bachelor's degree is required and advanced degree in a relevant discipline (e.g. J.D., MBA, other) is strongly preferred.


• Experience in the Pharmaceutical/Biotech/Life Sciences industry is required;


• A minimum of 8-10 years Compliance experience, some of which should be as a functional leader/ member of a leadership team in a life sciences-related field.


• Strong preference for hands-on experience in building out a commercial compliance program and function for U.S. pharma, biotech, or device firm in preparation for impending product launch(es);


• As a member of global team, ability to work, collaborate, and communicate globally and across multiple cultures with awareness and sensitivity is required.


• Strong initiative, independence, objectivity and persuasion skills required.


• Strong attention to detail and the ability to think and operate both strategically and operationally is important.


• A demonstrated ability to work in a highly matrixed environment is key.


• Experience with Compliance and/or Finance systems plus project management will be helpful in this role.


• In-depth, latest knowledge of U.S. PhRMA Code, Anti-kickback, and FDA law and regulations, and compliance program standards and requirements; some knowledge of data protection/ HIPAA and transparency standards; deep understanding of U.S. enforcement environment and best practice approaches to enabling compliance in pharma/ biotech industry expected.


• This role may have support staff initially or shortly after hire, and as such it is expected that candidate has some people management experience/skills.


• Exceptional communication skills, attentive listener, team player


• Robust compliance risk management, strategic, and analytic skills


• Robust communication skills (both written & verbal) is a must.


• Strong understanding of pharma/ biotech industry and business, with ability to provide innovative, risk-intelligent alternative solutions to assuring compliance, as appropriate.

In case you have any questions, please feel free to reach out to Recruiter Rebecca Fine @ refi@genmab.com.

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab's culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

Please note that if you are applying for a position in the Netherlands; Genmab's policy for all permanently budgeted hires in this location is to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy .