Associate Director/Director, CMC Writing

Found in: beBee S DK - 3 weeks ago

Valby, Denmark Genmab AS Full time

The Role

Genmab is now searching for an Associate Director/Director, Team Lead CMC Writing, to join CMC Operations in Copenhagen.

Genmab´s clinical pipeline is in an intensive growth period. While existing projects go from First-in-Human trials to Late-stage development, new projects continuously are added to broaden the Early-Stage development pipeline. Therefore, Genmab is now looking for an Associate Director/Director, CMC Writing to lead the CMC Writer Team, responsible for all submission authoring and responses to global regulators through clinical development of Genmab’s pipeline programs.

For the right person, this is a unique opportunity to grow as Team Lead/Manger, and to develop the current team further on its way to becoming a Center of Excellence for CMC Writing.

The Team

The CMC Writing team resides in the New Product Introduction (NPI) team of CMC Operations and currently consists of 4 CMC Writing SMEs, with a plan to significantly broaden the team base with additional expertise in the next 2 years. This position reports to Vice President, CMC, NPI. CMC Operations in Denmark is currently approaching close to team members.
 

Responsibilities

The main responsibility of the Associate Director/Director, Team Lead CMC Writing, will be leading the CMC Writing Team and managing its overall project deliveries and assignments for CMC Writing required by Genmab drugs in clinical trials. The overall responsibilities include the following:

  • Providing leadership and developing the CMC regulatory writing strategy together with the project teams, relevant CMC team leads and Department Heads as well as important stakeholders as RA CMC and Quality Assurance.
  • Line Manager for the CMC Writing Team, enabling appropriate resourcing to each development programs’ CMC writing task.
  • Develop the CMC Writing Team into a Center of Excellence for CMC Writing:
    • enabling the CMC Writing Team to support at least 3-5 new INDs/CTAs
    • doubling the amount of preclinical/clinical programs to more than 25 in the years to come
    • increase the team from the current 4 CMC writers and provide coaching and career development for existing and new team members
    • Authoring of INDs/CTAs for Genmab programs in clinical development
    • Authoring of CMC documentation relating to major CMC changes (e.g. process improvements/changes, scale-up and comparability) for Genmab programs in clinical development.
    • Managing the timely authoring and internal review of submissions through appropriate project management tools
    • Continuous learning from ongoing programs to optimize CMC regulatory documents, minimize regulatory CMC regulatory questions and proposing continuous improvements in CMC development based on recent regulatory input.
    • Readiness to involve Artificial Intelligence Technology into the CMC Writing process.
    • Facilitate and support CMC Writing SMEs collaboration with internal and external (CMO) teams to enable input to CMC regulatory writing and question reply in time and with high quality.
    • Provide strategic input on the impact of changing regulatory guidance to Genmab CMC processes, e.g. changes in ICH or USP/EP guidelines.

      Requirements

    • You have a strong interest in leading and developing people and have several years of experience as Line Manager of Subject Matter Expert teams.
  • Excellent communication skills and are known as a leader who drives change and innovation
Understanding the increasing CMC requirements through the clinical development phases, enabling a meaningful level of depth and content for submission, and thereby preparing the programs for smooth approval for clinical development and putting programs in a good position for future marketing authorization applications.You have a background working with biopharmaceuticals and at least 10-15 years industry experience.You have a broad experience from CMC authoring for biopharmaceuticals (large molecules/mAB) covering early and late-stage CMC filings and question and response rounds with US and European AuthoritiesGood Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the regulatory and quality control of biological products.You hold a relevant degree in natural science or bioprocess engineering

Moreover, you meet the following personal requirements:

Ability to work successfully under pressure in a fast-paced environment and with tight timelinesYou have a structured and systematic approach and a flair for IT systemsYou have a preference and strong ability for using English, both in writing and speaking and understand on how to finetune documents in a regulatory environmentTeam player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders to support product development programsYou are result- and goal-oriented and committed to contributing to the overall success of GenmabAbility to manage multiple tasks, prioritize work and define steps needed to achieve project and team goals

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialized people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.

About You

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

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