Genmab
Senior Manager, Clinical Trial Disclosure Specialist
Genmab, Princeton, New Jersey, us, 08543
Senior Manager, Clinical Trial Disclosure Specialist
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Senior Manager, Clinical Trial Disclosure Specialist
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Genmab . The Role
Genmab is committed to transparency of clinical trial research. The Clinical Trial Disclosure & Transparency (CTD&T) team resides within Development Operations and ensures successful conduct and reporting of clinical trials. We are seeking a Senior Manager to join the CTD&T team. The role offers a meaningful blend of operational and strategic tasks in a collaborative environment where quality, shared purpose, and cross-functional support are central. In this role, you will execute against global and national disclosure regulations across the Genmab portfolio. You will engage internal and external stakeholders to ensure consistent and responsible disclosure and transparency practices. The position requires strong expertise in disclosure requirements and regulatory processes, coupled with organizational and communication skills, while maintaining a commitment to quality, integrity, and Genmab\'s mission. Responsibilities
Manage, track, and maintain overall responsibility for the disclosure of clinical trial protocols and results on ClinicalTrials.gov, EU CTIS, and other applicable registries/platforms. Support and provide guidance on redaction activities. Ensure development of plain language results summaries. Stay updated on industry guidelines to ensure compliance. Support updating SOPs, contribute to process improvements, and maintain adherence to established standards. Oversee vendor performance related to transparency deliverables. Liaise with clinical CROs to ensure consistent messaging across study registries. Deliver training on Genmab\'s disclosure processes to internal staff and provide guidance to CROs and vendors as needed. Ensure internal teams are informed of updated or new requirements and laws. Manage unsolicited requests received via the clinicaltrials@genmab.com mailbox. Requirements
5+ years of clinical trial disclosure experience, including a Bachelor\'s or Master\'s degree with relevant specialization. Strong knowledge of disclosure requirements, technology, and platforms. Proven ability to lead projects and facilitate cross-functional collaboration. Excellent written and verbal communication. Previous experience as a Medical Writer is advantageous, given the close alignment between CTD&T and Medical Writing teams. Personal requirements
Engaged colleague with a positive and collaborative mindset. Strong organizational skills; able to manage conflicting priorities. High level of integrity, accuracy, and attention to detail. Quality mindset with the ability to prioritize in a fast-paced and evolving environment. Result- and goal-oriented, committed to contributing to Genmab\'s success. Salary and Benefits
For US-based candidates, the proposed salary band is
$126,240.00 — $189,360.00 . The actual offer will consider a range of factors, including skills, qualifications, experience, and location. Some positions are eligible for additional compensation such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional well-being. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health benefits: Two medical plan options (including HDHP with HSA), dental, and vision Voluntary plans: Critical illness, accident, and hospital indemnity insurance Paid time off: Vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support resources: Child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account About Genmab
Genmab is an international biotechnology company focused on improving patients\' lives through innovative antibody therapeutics. Established in 1999 and headquartered in Copenhagen, Denmark, Genmab operates globally with a presence in North America, Europe, and Asia Pacific. For more information, visit Genmab.com. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy and Job Applicant Privacy Notice on genmab.com. Locations
Genmab supports flexible, agile working environments. Offices are open, community-based spaces, and remote work is accommodated where possible. Note: This description focuses on the Senior Manager, Clinical Trial Disclosure Specialist role and core expectations. It does not include unrelated job postings or recommendations.
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Join to apply for the
Senior Manager, Clinical Trial Disclosure Specialist
role at
Genmab . The Role
Genmab is committed to transparency of clinical trial research. The Clinical Trial Disclosure & Transparency (CTD&T) team resides within Development Operations and ensures successful conduct and reporting of clinical trials. We are seeking a Senior Manager to join the CTD&T team. The role offers a meaningful blend of operational and strategic tasks in a collaborative environment where quality, shared purpose, and cross-functional support are central. In this role, you will execute against global and national disclosure regulations across the Genmab portfolio. You will engage internal and external stakeholders to ensure consistent and responsible disclosure and transparency practices. The position requires strong expertise in disclosure requirements and regulatory processes, coupled with organizational and communication skills, while maintaining a commitment to quality, integrity, and Genmab\'s mission. Responsibilities
Manage, track, and maintain overall responsibility for the disclosure of clinical trial protocols and results on ClinicalTrials.gov, EU CTIS, and other applicable registries/platforms. Support and provide guidance on redaction activities. Ensure development of plain language results summaries. Stay updated on industry guidelines to ensure compliance. Support updating SOPs, contribute to process improvements, and maintain adherence to established standards. Oversee vendor performance related to transparency deliverables. Liaise with clinical CROs to ensure consistent messaging across study registries. Deliver training on Genmab\'s disclosure processes to internal staff and provide guidance to CROs and vendors as needed. Ensure internal teams are informed of updated or new requirements and laws. Manage unsolicited requests received via the clinicaltrials@genmab.com mailbox. Requirements
5+ years of clinical trial disclosure experience, including a Bachelor\'s or Master\'s degree with relevant specialization. Strong knowledge of disclosure requirements, technology, and platforms. Proven ability to lead projects and facilitate cross-functional collaboration. Excellent written and verbal communication. Previous experience as a Medical Writer is advantageous, given the close alignment between CTD&T and Medical Writing teams. Personal requirements
Engaged colleague with a positive and collaborative mindset. Strong organizational skills; able to manage conflicting priorities. High level of integrity, accuracy, and attention to detail. Quality mindset with the ability to prioritize in a fast-paced and evolving environment. Result- and goal-oriented, committed to contributing to Genmab\'s success. Salary and Benefits
For US-based candidates, the proposed salary band is
$126,240.00 — $189,360.00 . The actual offer will consider a range of factors, including skills, qualifications, experience, and location. Some positions are eligible for additional compensation such as discretionary bonuses and long-term incentives. When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional well-being. Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan: 100% match on the first 6% of contributions Health benefits: Two medical plan options (including HDHP with HSA), dental, and vision Voluntary plans: Critical illness, accident, and hospital indemnity insurance Paid time off: Vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support resources: Child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account About Genmab
Genmab is an international biotechnology company focused on improving patients\' lives through innovative antibody therapeutics. Established in 1999 and headquartered in Copenhagen, Denmark, Genmab operates globally with a presence in North America, Europe, and Asia Pacific. For more information, visit Genmab.com. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy and Job Applicant Privacy Notice on genmab.com. Locations
Genmab supports flexible, agile working environments. Offices are open, community-based spaces, and remote work is accommodated where possible. Note: This description focuses on the Senior Manager, Clinical Trial Disclosure Specialist role and core expectations. It does not include unrelated job postings or recommendations.
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