Senior Manager, Clinical Trial Disclosure & Transparency

BioNJ Inc.; New Jersey; Teletrabalho; USD 133 000 - 199 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) match

Health benefits

Voluntary plans

Paid time off

Support resources

Lifestyle Spending Account

Resumo da oferta

Genmab is seeking a Senior Manager for CTD&T to drive disclosure across a global portfolio. You will work with internal teams and external CROs to ensure compliant and transparent reporting of trials, develop plain language summaries, and maintain adherence to evolving regulations.

You will manage registries, oversee vendors, and train staff on disclosure processes, while staying current with industry guidelines and SOP updates in a collaborative, high-impact environment.

Qualificações

• 5+ years of clinical trial disclosure experience with a relevant degree
• Strong knowledge of disclosure requirements, technology, and platforms
• Proven ability to lead projects and collaborate cross-functionally
• Excellent written and verbal communication that is concise and respectful
• Medical writing experience is advantageous and beneficial

Responsabilidades

• Manage disclosure of clinical trial protocols and results on ClinicalTrials.gov, EU CTIS, and other platforms
• Guide redaction activities as needed
• Develop plain language results summaries
• Stay updated on industry guidelines and compliance
• Update SOPs and drive process improvements
• Oversee vendor performance related to transparency deliverables
• Coordinate with CROs to ensure consistent messaging
• Deliver training on disclosure processes to internal staff and CROs
• Inform teams of updated requirements and laws
• Handle unsolicited requests via the designated mailbox

Conhecimentos

Clinical trial disclosure experience

Regulatory knowledge

Project leadership

Excellent communication

Medical writing experience

Formação académica

Bachelor's or Master's in relevant field

Descrição da oferta de emprego

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

Job Description

Genmab is committed to transparency of clinical trial research. We recognize the scientific and ethical value of sharing clinical trial information in a non-biased and timely manner to benefit patients and other external stakeholders. The Clinical Trial Disclosure & Transparency (CTD&T) team resides within Clinical Trial Delivery, which hosts key functions for ensuring successful conduct and reporting of clinical trials.

We are now looking for a new Senior Manager to join our 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 to how we work.

In the role as Senior Manager of CTD&T, you will be executing against the global and national disclosure regulations and requirements across the entire Genmab portfolio. This role engages with 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 strong organizational and communication skills, while maintaining a commitment to quality, integrity, and advancing 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 in 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.
• Ensure management of unsolicited requests received via the [e-mail] 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, that is effective, respectful, and concise.
• Previous experience as a Medical Writer is advantageous, given the close alignment between the CTD&T and Medical Writing teams.

For US based candidates, the proposed salary band for this position is as follows:

$132,800.00---$199,200.00

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of 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 wellness. 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 insurance
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
• Support Resources: Access to 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 for wellness and personal expenses

Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on your website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.