- Job Title Associate Director, Trial Start Up Lead
- Hiring Organization Genmab
- Company Website https://www.genmab.com/
- Remote Locations Worldwide
- Job Type Remote, Full-Time
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 Role & Department
The Associate Director, Trial Start Up Lead is key member of the Trial Strategy and Delivery Team, responsible for overseeing and driving trial start up on a compound level in close collaboration with the clinical project lead, the trial start up team and the clinical CROs.
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.
Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.
When you work with us, you’ll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other – rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.
- Provide CPL with operational insights for initial trial strategies related to start-up, including country selection, submission strategy, and site selection/activation
- Oversee delivery of timely site activation across trials within a program
- Oversee planning and execution of start-up activities across trials within a program
- Serve as the point of escalation for start-up managers on trial start-up issues
- Identify underlying causes and develop effective solutions to mitigate or eliminate challenges
- Work with team members to develop and implement solutions to identify challenges
- Contribute to novel collaborations with relevant recruitment companies, site referral networks, and CRO networks
- Collaborate with Genmab legal on country-specific CTA templates and master CTA
- Develop CDA strategy for compound/trial
- Assess Start-Up KPI/KQI from CROs
- Support IRB/EC/CEC submissions
- Ensure learnings from IRB/EC/CEC feedback across clinical trials within a program but also across different programs are collected and shared
- Drive interactions with CRO for start-up activities and optimization
- Support, identify, and address site activation challenges on a program level and
- Document and share lessons learned across trials and programs
- Line management for up to 7 members of the trial start up team.
- A minimum of 12 years of relevant global study start-up experience from biotechnology-/pharmaceutical-, CRO- or healthcare industry
- Solid understanding of trial start up
- Demonstrated ability to leadand collaborate with cross-functional teams to drive operational excellence
- Experience in leading & managing global teams
- Experience in mentoring trial start up managers
- Vendor management experience
- Strong stakeholder management
- Ability to anticipate issues with proactivity to offer solutions & to timely escalate risks and issues when needed
- Ability to foster a “One Team” spirit, inclusive mindset
- Confidence to challenging status-quo thinking and behaviour; can work with agility and an innovative mindset
- Excellent written and oral communication skills
- Bachelor’s Degree within life science or equivalent combination of education, training, and relevant experience
- Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines would be beneficial
- Experience in line management (preferred)
- Strong organizational skills, including the ability to prioritize and handle a high volume of tasks within a given timeframe
- Ability to proactively identify risks, develop mitigations & resolve issues
- Good understanding of the operational structure within CRO
- Strategic mindset
Moreover, you meet the following personal requirements
- You can work independently as well as in teams
- You are capable of prioritizing work in a fast paced and ever-changing environment
- You have a quality focus and an eye for detail
- You are result and goal-oriented and committed to contributing to the overall success of Genmab
This role can be located in Copenhagen, Denmark or Princeton, NJ or Utrecht, the Netherlands; and is hybrid or can be remote.
- 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
How To Apply
Click “Apply” below to fill in the application form!
- Remote Job Location Copenhagen, Denmark or Princeton, NJ or Utrecht, the Netherlands or Anywhere
- Salary Offer to be discussed
- Experience Level Senior Level
- Education Level Bachelor's Degree
- Working Hours to be arranged (full time based )
- Job Application Via Custom Application Page