(Associate) Director, Global Drug Safety

5 maanden geleden

Utrecht, Nederland Genmab Voltijd

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.

About the Role: As the (Associate) Director, Global Drug Safety & Pharmacovigilance Physician at Genmab, where your expertise will navigate the safety of ground-breaking cancer therapies. With a Medical Doctorate and over 12 years in drug safety, ideally in oncology, you will lead critical safety evaluations and risk management activities. Your role involves collaboration with cross-functional teams, leading all aspects of safety issue management, and engaging with regulatory authorities. A profound understanding of global PV regulations, safety databases, and mentorship skills are essential. Propel your career forward by shaping the future of oncology treatments with us.

 

Your Responsibilities:

  • Lead all major pre- and post-marketing safety-related activities including signal, benefit-risk evaluation and risk management activities for own area
  • Effectively collaborate with drug safety and cross-functional teams for safety assessment (e.g. review of AEs and scientific literature; safety reports), ongoing surveillance, and related communication around assigned Genmab products
  • Be responsible for handling of safety issues and implementing risk mitigation activities, and propose systemic solutions 
  • Provide inputs to different documents (e.g. trial protocols, amendments and plans; clinical trial reports; eCRFs/CRFs;TMFs) based on review
  • Prepare relevant documentation (e.g. benefit/risk sections of aggregate reports; safety summaries) as per regulatory requirements 
  • Lead internal & external forums (e.g. external Data monitoring Committees (DMCs); Genmab Safety Committees) for assigned products
  • Provide guidance, oversight, and training around safety to relevant collaborators (e.g. Genmab employees, CROs, Investigators)
  • Proactively engage with internal team members (e.g. multidisciplinary project groups) and external collaborators (e.g. external experts and partners around emerging landscape; regulatory authorities around audits and inspections)
  • Train and mentor teams on emerging safety aspects and PV processes/technologies/regulations

 

Who you are:

  • An MD with at least 12 years of experience in drug safety/pharmacovigilance, ideally within oncology
  • A seasoned navigator of the global PV regulatory landscape, proficient in audits, inspections, and regulatory authority interactions.
  • A strategic thinker with experience in safety databases and electronic data capture systems
  • A leader who guides, mentors, and encourages your team towards excellence.

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 little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

  • Global Drug Safety Director

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a seasoned professional to lead our Global Drug Safety & Pharmacovigilance team at Genmab. As a Medical Doctor with over 12 years of experience in drug safety, you will navigate the safety of groundbreaking cancer therapies and collaborate with cross-functional teams to ensure the highest level of safety and quality.Your...

  • Director, Global Drug Safety and Pharmacovigilance

    2 maanden geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a highly skilled and experienced Director, Global Drug Safety and Pharmacovigilance to join our team at Genmab. As a key member of our organization, you will be responsible for leading critical safety evaluations and risk management activities for our innovative cancer therapies.Key ResponsibilitiesLead all major pre- and...

  • Associate Director, Qp Operations

    5 maanden geleden

    Utrecht, Nederland Bristol-Myers Squibb Voltijd

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • Associate, Lab Safety

    5 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    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...

  • (Associate) Director, Biostatistician

    5 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    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...

  • Associate Director, Clinical Research Scientist

    5 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    The Role This position serves as a key role in the effective implementation of the global development strategy leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development (including clinical trial implementation, and oversight of all aspects of clinical development) working...

  • Finance Director

    3 weken geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Job Title: Associate Director Holdings ControllerBristol Myers Squibb is seeking a highly skilled and experienced Finance Associate Director to lead our finance operations for all our Holdings entities in the Netherlands. As the Finance Associate Director, you will play a critical role in overseeing financial activities, providing strategic guidance, and...

  • Associate Director, Translational Medicine

    3 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a highly skilled and experienced Associate Director, Translational Medicine to join our team at Genmab. As a key member of our Translational Research & Precision Medicine Department, you will play a critical role in driving translational research projects and external collaborations for clinical programs within Genmab.Key...

  • Clinical Research Director

    1 maand geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleThis is a key position in the implementation of our global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more compounds in various stages of clinical development. The successful candidate will work closely with the Medical Director and other cross-functions to provide high-quality and...

  • Associate Director of Finance

    1 maand geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Job SummaryWe are seeking a highly skilled and experienced Finance Associate Director to lead our finance operations for all our Holdings entities in the Netherlands. As the Finance Associate Director, you will play a critical role in overseeing financial activities, providing strategic guidance, and ensuring compliance with regulatory requirements.Key...

  • Senior Finance Director

    3 weken geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Job SummaryWe are seeking a highly skilled and experienced Finance Associate Director to lead our finance operations for all our Holdings entities in the Netherlands. As the Finance Associate Director, you will play a critical role in overseeing financial activities, providing strategic guidance, and ensuring compliance with regulatory requirements.Key...

  • Associate Director of Finance

    1 maand geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Job SummaryBristol Myers Squibb is seeking a highly skilled and experienced Finance Associate Director to lead our finance operations for all our Holdings entities in the Netherlands. As the Finance Associate Director, you will play a critical role in overseeing financial activities, providing strategic guidance, and ensuring compliance with regulatory...

  • Associate Director, Translational Medicine

    4 weken geleden

    Utrecht, Utrecht, Nederland Genmab Voltijd

    About the RoleWe are seeking a highly skilled and experienced Associate Director, Translational Medicine to join our team at Genmab. As a key member of our Translational Research & Precision Medicine Department, you will play a critical role in advancing the clinical development of innovative and differentiated antibody therapeutics for the treatment of...

  • Associate Director of Finance Operations

    2 maanden geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Job SummaryWe are seeking a highly skilled and experienced Finance Associate Director to lead our finance operations for all our Holdings entities in the Netherlands. As the Finance Associate Director, you will play a critical role in overseeing financial activities, providing strategic guidance, and ensuring compliance with regulatory requirements.Key...

  • Associate Director, Translational Medicine

    5 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    The Role The Associate Director, Translational Medicine (TM) is a member of the TM team, which is embedded in the global Translational Research & Precision Medicine Department. The TM team focuses on preclinical and clinical translational research to advance the clinical development of innovative and differentiated antibody therapeutics for the treatment of...

  • Associate Director, QA GCP/PV

    5 maanden geleden

    Utrecht, Nederland Genmab Voltijd

    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...

  • Associate Director Holdings Controller

    5 maanden geleden

    Utrecht, Nederland Bristol-Myers Squibb Voltijd

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...

  • (Associate) Group Leader Drug Development

    1 maand geleden

    Utrecht Oost, Nederland Prinses Máxima Centrum Voltijd

    Improvements in outcome for children with cancer that both increase survival and reduce late effects of treatment may be realized by the introduction of novel (targeted) drugs or ATMPs with different modes of action than the existing therapy modalities, such as chemotherapy. In order to further strengthen our capacity for clinical innovation and to expand...

  • Associate Director of Finance

    3 weken geleden

    Utrecht, Utrecht, Nederland Bristol Myers Squibb Voltijd

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Finance Associate Director to lead our finance operations for all our Holdings entities in the Netherlands.Scope of the RoleThe Finance Associate...

  • Clinical Research Associate

    3 weken geleden

    Utrecht, Utrecht, Nederland PRA Voltijd

    At ICON, we are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for ensuring the appropriate development, validation, and use of analytical methods in our bioanalytical or clinical laboratory.Key responsibilities include:Primary processing of clinical safety samplesPrimary...