Clinical Operations Director, Programming Strategy
1 month ago
We are seeking a highly experienced Clinical Operations Director to lead our Programming Strategy team at Genmab. As a key member of our Development Operations Leadership Team, you will be responsible for driving the overall strategy and development areas of the organization.
About the RoleIn this role, you will work closely with our HoF Biostatistics and HoF Data Management teams to drive programming activities across clinical and regulatory operations. You will be responsible for establishing standard processes, templates, and clinical standards to ensure quality and timelines of regulatory filings and clinical documentation.
You will also oversee outsourced programming activities, selecting and managing programmers, and ensuring clear expectations and responsibilities are defined in work orders and manuals. Your extensive experience with NDA, MAA, BLA filings is essential for this position.
Key Responsibilities- Drive process development and standards within programming.
- Develop resource planning and outsourcing strategies for programming activities.
- Prepare and participate in audits and inspections.
- Contribute to ongoing improvements and lessons learned in cross-functional and global collaboration.
- Manage and supervise a team of skilled professionals.
- Bachelor's degree or equivalent required.
- Minimum 15+ years of experience in clinical trial management and 10+ years of people management experience.
- SAS programming or similar languages such as R, Python, etc.
- Analytical and problem-solving skills.
This role can be based in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, the Netherlands and is hybrid. The estimated salary range for this position is $150,000 - $180,000 depending on location and experience.
-
Copenhagen, Copenhagen, Denmark Genmab Full timeJob OverviewWe are seeking a highly skilled Senior Director, Head of Programming to join our team at Genmab. This role will be responsible for leading the development and implementation of programming processes and standards within the organization.As a Senior Director, you will play a key role in driving the overall strategy related to programming...
-
Clinical Operations Director
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeWe are seeking an exceptional Clinical Operations Director to join our team at Genmab.This is a unique opportunity to lead our Global Inspection Readiness function, driving excellence in clinical trial management and ensuring compliance with regulatory standards. As a seasoned professional, you will oversee the readiness of clinical trial procedures and...
-
Director of Programming Innovation
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly skilled Director of Programming Innovation to join our team at Genmab. As a key member of our Development Operations Leadership Team, you will play a crucial role in defining the overall strategy and identifying development areas within the organization.The ideal candidate will have extensive experience in clinical trial...
-
Clinical Development Director
1 month ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeAbout the RoleWe are seeking a skilled Clinical Program Lead to join our Global Clinical Development (GCD) organization at Ferring Pharmaceuticals A/S. As a key member of our team, you will play a central role in bridging the clinical parts of our matrix organization, driving clinical development programs, and ensuring alignment of execution strategies,...
-
Copenhagen, Copenhagen, Denmark Genmab Full time**About the Role**We are seeking an experienced Clinical Operations Director to lead our Global Trial Readiness function at Genmab. As a key member of our Operational Excellence department, you will play a vital role in ensuring the readiness of our clinical trials for regulatory scrutiny.In this strategic leadership position, you will be responsible for...
-
Clinical Director for Cancer Therapy
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab is seeking a Clinical Director for Cancer Therapy to join our Trial Strategy and Delivery department.This role involves managing a team of Clinical Trial Associates (CTAs) and reporting to the Head of Trial Management. As a Clinical Director, you will work closely with Global Clinical Trial Managers (GCTMs), Clinical Project Leads...
-
Senior Program Director
4 weeks ago
Copenhagen, Copenhagen, Denmark The LEGO Group Full timeAbout The RoleWe are seeking a Senior Program Director to lead our technical program management initiatives, driving the development of new technology products and services at The LEGO Group. This is an exciting opportunity for an experienced leader to join our Marketing & Channels Technology Team and play a key part in shaping our digital strategy.The...
-
Copenhagen, Copenhagen, Denmark Genmab AS Full timeSenior Director, Regulatory Affairs Strategy LeaderWe are seeking an experienced and passionate leader to join our Global Regulatory Affairs organization at Genmab A/S. As a Senior Director, Regulatory Affairs Strategy Leader, you will be responsible for developing global strategies to advance our portfolio of development pipeline candidate drugs and...
-
Clinical Project Director
4 weeks ago
Copenhagen, Copenhagen, Denmark Ferring Holding SA Full timeSenior Clinical Project Manager Role at Ferring DenmarkWe are seeking a seasoned Clinical Project Director to lead our clinical trial team in the Oresund region. As a key member of our Global Clinical Operations, you will be responsible for planning and executing complex clinical trials with high levels of complexity.About the JobAs a Senior Clinical Project...
-
Clinical Development Strategist
4 weeks ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeFerring Pharmaceuticals A/S is a leading global biopharmaceutical company dedicated to helping people build families and live better lives.We are seeking an experienced Clinical Development Strategist to join our Global Clinical Development organization, reporting directly to the Senior Director of Global Clinical Program Management.The ideal candidate will...
-
Clinical Supply Operations Specialist
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeTransform the lives of patients with cancer and other serious diseases by joining Genmab's dynamic team as a Clinical Supply Operations Specialist.About UsGenmab is a pioneering biotechnology company committed to developing innovative antibody therapeutics. With over 20 years of experience, our team has invented next-generation antibody technology platforms,...
-
Director of Financial Operations and Strategy
3 weeks ago
Copenhagen, Copenhagen, Denmark Nornorm Full timeAt NORNORM, we are revolutionizing workspaces with sustainability at the core. As a global company scaling rapidly, we need a skilled Director of Financial Operations and Strategy to lead our finance operations and drive growth.About the RoleThis is a high-growth opportunity for an experienced professional who excels in operational finance and thrives in...
-
Clinical Program Lead
2 months ago
Copenhagen, Copenhagen, Denmark Ferring Pharmaceuticals AS Full timeJob Description: As a Clinical Program Lead at Ferring Pharmaceuticals A/S, you will play a central role in bridging the clinical parts of our matrix organization, ensuring alignment of execution strategies, program standards, and knowledge across clinical trials within a program.Your Key Responsibilities:Lead, coordinate, motivate, and drive...
-
Research Scientist
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeTransform Lives through Innovative Cancer TreatmentAbout the RoleWe are seeking a highly motivated Clinical Research Scientist to join our team in the implementation of clinical trials within a program in alignment with our global development strategy. The ideal candidate will work collaboratively with a Medical Director and Sr. level Clinical Research...
-
Clinical Research Scientist
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeTransforming Lives through Cancer Treatment InnovationWe are seeking a highly skilled and experienced Clinical Research Scientist to join our dynamic team at Genmab. As a key member of our clinical development program, you will be responsible for leading or co-leading less-complex clinical trials within our programs.Key Responsibilities:Develop and execute...
-
Director of Regulatory Affairs and Strategy Lead
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a highly experienced Senior Director, Regulatory Affairs Strategy-EU/RoW to join our Global Regulatory Affairs organization.Key ResponsibilitiesDevelop and execute EU/ROW regulatory strategies for assigned programs, aligning with global development and commercial goals.Lead a team of Regulatory Strategists, providing mentorship...
-
International Medical Director
4 weeks ago
Copenhagen, Copenhagen, Denmark Novo Nordisk AS - Nn1 Full timeNovo Nordisk A/S - Nn1 is a dynamic company in an ever-evolving industry, driving innovation and excellence in patient care. We are seeking an experienced International Medical Director to lead our clinical development efforts for rare hemato-renal diseases.Job Description:This pivotal role will be responsible for guiding clinical programs through every...
-
Clinical Trial Planning Director
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout GenmabGenmab is a biotechnology company committed to transforming the lives of patients through innovative cancer treatment.About the RoleWe are seeking a skilled Clinical Trial Planning Director to join our Development Program Management team. In this role, you will play a pivotal part in managing clinical trials from initiation to final reporting,...
-
Cancer Treatment Medical Director
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeTransform Cancer Patient Lives as a Medical DirectorAbout the Role:We are seeking a skilled Medical Director to join our Global Oncology Medical Affairs Team. As a key member of our team, you will play a vital role in developing and executing strategic plans for epcoritamab.Main Responsibilities:Support cross-functional pre-launch/launch activities to drive...
-
Clinical Research Scientist
2 months ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleThis position contributes to the 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 early clinical development.ResponsibilitiesLead or co-lead one or more clinical trial(s) in a therapeutic area for one or more compounds.Work closely with the...