Vice President, Global Drug Safety & PV Physician

At Genmab we are dedicated to building extranotordinary 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!

The Role

Reporting to the VP Head of Global Drug Safety & PV the Vice President Global Drug Safety & Pharmacovigilance Physician serves as the safety expert accountable for the global safety strategy and overall safety profile for the assigned Genmab products (investigational) throughout their lifecycle. This includes leading all major pre- and post-marketing safety related deliverables including signal benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels in the organization as well as with external Regulatory Authorities. This individual will work together with other Drug Safety (DS) staff in managing the safety assessment of products including review of individual and aggregate AEs and the scientific literature preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The ability to work in a dynamic changing environment to meet corporate and patient needs is essential.

We have a hybrid model that requires being onsite 60% of the time in Princeton NJ.

Responsibilities:

• Act as the Medical Safety Lead for one or more Genmab products across the life cycle of the products starting from early development throughout post-marketing
• Lead all safety related activities to support regulatory filings and launch for assigned products.
• Act as a Subject Matter Expert (SME) for other safety physicians and cross functional project teams in addressing PV related topics
• Support the GDS PV Leadership in creating an extranotordinary Global Genmab Safety/Pharmacovigilance Team.
• Provide oversight and input into safety data review signal detection risk communication including safety information updates and mitigation of potential risks.
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment clinical trial data interpretation and medical review of individual case reports of serious adverse events.
• Address safety-related topics as a member of the GDS PV Leadership Team and CDT
• Act as the lead safety representative in CDT or JCDT with partners to provide a strategic input to clinical development programs
• Work with Medical Directors Genmab Safety physicians CRO Safety Physicians and Safety Scientists on safety monitoring and assessment activities
• Ensure that the development team members understand the fundamental of pharmacovigilance according to their roles in the organization so they can understand and support when needed the PV-related activities.
• Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations.
• Provide oversight and inputs to ensure quality and timely delivery of aggregate safety reports.
• Review safety sections on cross-functional documents including study Protocols/Amendments Study reports/Trial plans Investigators Brochures Subject Informed Consent Integrated Safety Summaries scientific articles and regulatory reports.
• Always ensure audit and inspection readiness.
• Mentor and develop team members for professional development and enhancement. Create Enthusiastic team player that brings a positive attitude.
• Strong listening skills to foster an open collaborative environment within the team and across other line functions.

Requirements:

MD required; clinical research and/or fellowship training in oncology/hematology pharmacology or other relevant specialty is a plus

Minimum 15 years Drug Safety/Pharmacovigilance experience plus 2 years clinical development experience; other relevant experience may be considered

Excellent understanding of global PV regulatory environment with working knowledge of international regulations initiatives standards and Good Pharmacovigilance practices (GVP)

Exposure to working relationship with the FDA and other regulatory authorities is preferred

Strong knowledge of individual adverse event case report processing triage and medical review

Working knowledge of safety databases (ARISg ARGUS or other safety database applications) and electronic data capture systems is preferred

MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries

Working experience with PV audit process with active participation in Regulatory Authority Inspections

Ability to manage multiple tasks with deadlines in fast-paced working environment with demonstrated successful management of complex projects within the scope of this position

Excellent knowledge of drug development process

Requires a high level of initiative and independence

Must have excellent written and oral communication skills resourcefulness and personal organization skills together with demonstrated cross-functional teamwork

Computer literacy with proficiency in Microsoft Excel PowerPoint and Word

Experience leading a team of physicians

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

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 youre 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

About You

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can grapple with the unknown and be innovative

• You have experience working in a fast-growing dynamic company (or a strong desire to)

• You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment when possible for the betterment of employee work-life balance. Our offices are crafted as open community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether youre in one of our office spaces or working remotely we thrive on connecting with each other to innovate.

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 Genmabs 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 and follow us on LinkedIn and X.

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Please note that if you are applying for a position in the Netherlands Genmabs 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.