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Genmab
Princeton, New Jersey, United States (on-site)
26 days ago
Genmab
Princeton, New Jersey, United States (on-site)
30 days ago
Genmab
Remote, United States (on-site)
30 days ago
Genmab
Princeton, New Jersey, United States
(on-site)
26 days ago
Job Function
Clinical Operations

Description

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

As HoF for Programming, the employee will be part of the Development Operations Leadership Team who defines the overall strategy and identify development areas of the organization and ensures that all teams and employees work toward the same objectives and work as one team.

As HoF for the Programming the employee will drive the overall strategy related to programming activities within Genmab in close collaboration with HoF, Biostatistics and HoF, Data Management. The employee is responsible for driving the programming activities across the clinical and regulatory activities related to development programmes/clinical trials and regulatory submissions/filing activities working closely together with relevant stakeholders within CO and across functions.

In addition, the employee will support the development of new therapies by ensuring integrity, consistency and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures and listings for decision making.

The employee will operationally support the Data Management, Statistics, Drug Safety, Medical and Clinical Pharmacology functions across one or more trial and/or programs.

The employee is responsible for establishing standard processes, templates and clinical standards to ensure the quality and timelines of regulatory filings and clinical documentation is in accordance with ICH-GCP and other relevant regulatory guidelines/ requirements.

The employee will drive the oversight of outsourced programming activities not limited to: selection and management of programmers, ensuring that expectations/responsibilities are clearly defined and described in workorders and manuals. The outsourcing activities will be done in close collaboration with HoF Biostatistics and HoF Data Management.

It is expected that the employee act as a role model, proactively engages in department activities, arrange lessons learned to share learnings, leads various initiative, contribute to the overall strategy of the department and proactively contributes to support a global organization.

This position builds strong relationship and close communication/interaction with internal e.g. Data management, biostatistics, regulatory affairs, non-clinical, medical and other functional areas as well as external stakeholders e.g. partners, regulatory authorities etc.

As HoF for the Programming you need to have extensive experience with NDA, MAA, BLA filings, you need to be systematic, organised, proactive, and accountable with good planning and coordination skills. The employee needs to be analytical with the ability to interpret clinical data and other complex information and effectively communicate expectations and information in a clear and concise manner.

As HoF for the Programming the employee may represent Clinical Operations in Project Boards, Global Development Teams and Operational Committee's/Steering Committee's with the partners.

As HoF for the Programming group the employee will be responsible for managing, coordinate, develop, supervise and support the employees in the team and ensure that the employees competencies reflect their responsibilities as outlined in their job descriptions.

Key Responsibilities:

The tasks and department responsibilities are a nonexclusive list of high-level tasks:
  • Drive process development and standards within programming where continuous improvements is in focus
  • Drive resource planning and outsourcing of programming activities
  • Prepare and participate in audits and inspections
  • Participate in due diligence activities, if applicable
  • Drive scientific forums/workshops/learnings, as applicable
  • Lead/contribute with knowledge sharing within the Clinical Operations
  • Lead and participate in cross-functional working groups/projects/task forces
  • Contributes to ongoing improvements and lessons learned in cross-functional and global collaboration and sharing of better practices and knowledge
  • Overall responsible for managing, supervise and developing of people in the Programming Team
  • Support developing of people
  • Development of training plans, ongoing training and JD for employees within own functional areas and ensuring employees
  • Keep own and employees dossier up to date and that employees within own functional areas are compliant (timely R&U of SOP, are sufficiently trained etc.).
  • Support the expansion of Development Operations in DK, NL, Japan and US and support development of people globally
  • Responsible for hiring of new employees within Programming in close collaboration with relevant stakeholders
  • Proactively contributes to support a global organization
  • Maintains up-to-date knowledge and competencies within relevant therapeutic, regulatory guidelines/requirements and ensure it is reflected in Genmab programming processes and standards
  • Participates and represent programming in teams and meetings
  • Further build a framework for the department focusing on the growth, developing new and "innovative" ways to work with internal and external partners in a global context utilizing an outsourced model
  • Drive or support various change initiatives
  • Keep overview of consultancy contract and costs within own area
  • Accountable for budgeting of activities related to programming


Other activities:
  • The employee may also support senior management on own or partnered.
  • The Employee shall render such other related services and duties as may be assigned to him/her from time to time by his/her supervisor.


As Senior Director, Head of Programming, it is expected that the employee:
  • Acts as a role model
  • Proactively engages in department activities
  • Arranges lessons learned to share learnings
  • Leads various initiatives within the department
  • Proactively contributes to support a global organization
  • Acts as mentor for new employees or consultants


Requirements - what you must have
  • Bachelor's degree required or equivalent (e.g., number of years of experience and/or skills)
  • Minimum of 15+ years of experience in clinical trial management and 10+ years of people management experience, leading highly competent and dedicated team(s).


Competences:
  • SAS programming or similar languages such as R, Python, etc.
  • Analytical and problem-solving skills
  • Knowledge of the CDISC SDTM and ADaM data models: the corresponding structures and organizations of the data.
  • Contextual understanding of the data
  • Writes efficient, easily maintained and well documented computer programs
  • Is systematic and organized in writing and archiving computer programs
  • Thorough
  • Proactive and Accountable and Goal oriented
  • Innovative
  • Good team player
  • Expert at sharing knowledge
  • Works independently, take responsibility and show initiative
  • Excellent communication skills
  • Excellent planning and coordinating skills
  • Ability to flexibly work on multiple tasks without compromise of the quality of the work


Where you will work

This role can be based in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, the Netherlands and is hybrid.

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

$206,250.00---$343,750.00

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 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.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

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.

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 https://www.genmab.com/privacy.

Please note that if you are applying for a position in the Netherlands, Genmab's 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.

Job ID: 72881932

Genmab is an international biotechnology company with the core purpose of guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative, and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulator...

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