Biomarker Operations Manager
Biomarker Operations Manager
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$ 105040 - 157560
1 Vacancy
Job Description
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
The Biomarker Operations Manager will work in multidisciplinary international project teams to discover and develop antibody therapeutics. The Biomarker Operations Manager will manage the operations and logistics necessary to execute the scientific strategy for Oncology projects contributing to the development of ground-breaking new medicines from concept to the market. The successful candidate will be responsible for working closely with the Director Biomarker Operations and all key stakeholders to ensure the Biomarker Operations function is an integral part of Genmab clinical studies moving forward.
Responsibilities
- Working with Clinical Management Teams (CMTs) and biomarker/translational research teams to implement and execute the clinical biomarker and translational sample strategy for projects
- Managing sample logistics and operations for clinical and biomarker samples working closely with CMT team personnel central laboratories and specialty lab vendors
- Planning coordinating and overseeing all operational activities required to manage the lifecycle of biomarker samples (collection processing analysis data delivery and cleaning process and final sample disposition)
- Providing biomarker operational expertise and guidance to cross-functional and CMTs
- Proactively supporting the CMTs during data cleaning process to ensure oversight of biomarker samples data transfer and reconciliation procedures
- Contributing to the assessment of site and lab feasibility for biomarker sample collection handling and storage
- Ensuring review of lab specifications and manuals as well as sample handling training and collection/processing materials for investigator sites/monitors together relevant internal and external stakeholders and the central lab
- Supporting presentations and trainings of sites and monitors as needed.
Requirements
- Bachelors degree or equivalent and 3 years of industry related experience
- Excellent knowledge and understanding of Oncology clinical trials and the role of biomarkers and translational medicine in clinical studies
- Extensive knowledge and understanding of clinical research ICH GCP GLP data management regulatory and legal issues/processes as they relate to biomarker samples
- Proven experience working in teams managing oncology clinical studies within the pharmaceutical/CRO industry
- Extensive experience working with sample/biomarker logistics and operations
- Experience with SOPs guidance and work instructions and ability to draft biomarker related documents or sections within these documents
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines
- Ability to be proactive enthusiastic and goal orientated
- Strong communication skills - both oral and written
For US based candidates the proposed salary band for this position is as follows:
$105040.00---$157560.00The 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.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice ().
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.
Required Experience:
Manager
Employment Type
Full-Time
