At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Drug Safety & Pharmacovigilance (GDS&PV) Physician role is a safety expert medical role contributing to the global safety strategy and overall safety profile for the assigned Genmab products (mainly investigational) throughout their lifecycle.

As our Associate Director, you must effectively interact cross-functionally at all levels in the organization, as well as with external parties, including Regulatory Authorities, as applicable. The role reports to the Senior Director MD, Team Lead.

You will work together with other Drug Safety 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 supporting the Team Lead.The ability to work in a dynamic, changing environment to meet corporate and patient needs is essential.

This position has a global perspective, and you will interact with stakeholders ranging from regulatory authorities and Data Monitoring Committees as well as colleagues from other Genmab sites. As Associate Director, GDS&PV Physician, you will be part of a highly skilled and international team and you will act as a GDS&PV ambassador cross company- e.g., by explaining and training on PV principles. Importantly, you are also expected to mentor more junior colleagues, and help them reach their best.

Key responsibilities include

Lead all major pre- and post-marketing safety-related activities including signal identification and assessment, benefit-risk evaluation and risk management activities for own area

Effectively collaborate with drug safety and cross-functional teams for safety assessments (e.g., review of AEs/SAEs and scientific literature; safety reports), ongoing surveillance, and related communication around assigned Genmab products

Oversee handling of safety issues and implementing risk mitigation activities

Provide inputs to different documents (e.g. trial protocols, amendments and plans; clinical trial reports; eCRFs;TMFs) based on review

Prepare relevant documentation (e.g., benefit/risk sections of aggregate reports; safety summaries)and Q&As as per regulatory requirements

Manage internal & external forums (e.g., external Data Monitoring Committees; Genmab Safety Committees)for assigned products

Provide guidance, oversight, and training around safety to relevant stakeholders (e.g. Genmab employees, CROs, Investigators)

Proactively engage with internal stakeholders (e.g. multidisciplinary project groups) and external stakeholders (e.g. external experts, partners, regulatory authorities)

Take part in audits and inspections

Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations

Requirements

MD required

Minimum requirement: 5 years' experience in in drug safety/pharmacovigilance covering both clinical development and post-marketing

Solid clinical judgement: experience in oncology is a plus

Experience with PV audits/ Regulatory Authority Inspections and worldwide regulatory authorities' interactions

Experience with global PV regulatory environment (regulations, initiatives, standards, GVP);MedDRA and WHODrug coding dictionaries

Experienced in individual adverse event case report processing, triage, and medical review

Experience with safety databases (ARISg, ARGUS, or other safety database applications) and electronic data capture systems preferred

Experience guiding and mentoring team members

Proven performance in earlier role/comparable role

Furthermore, you meet the following personal requirements:

Self-driven learner, pragmatic, problem solver, and curious

Team player, focused on the overall success of the team, the project, and Genmab

Strong communicator and good at building professional relations to colleagues, collaborators, and business partners

Proactive and able to prioritize work in a fast paced and changing environment

Result-and goal-oriented

Able to express own opinion with supporting arguments and facts

Thrive in a multicultural environment

This role is hybrid and located in Plainsboro, NJ and requires you to be in the office 3x per week.

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

$142,500.00---$237,500.00

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 bonuses.

About You
You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with diverse backgrounds
You are determined to do and be your best and take pride in enabling the best work of others on the team
You are not afraid to 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...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity