Aegerion Pharmaceuticals, Inc. is a global biopharmaceutical company with a diversified portfolio consisting of two commercially branded products, a Phase 3-ready Ultra-Orphan Fast Track and Orphan Drug designated asset.
Everyone at Aegerion plays a vital role in the development and commercialization of innovative therapies for patients with debilitating rare diseases. If you are passionate about patient outcomes and enthusiastic about building a world-class, global company, we invite you to consider joining us today.
At Aegerion Pharmaceuticals we will empower you to apply your skills and ideas to achieve success. You will interact with all levels of management and take charge of your future by joining us as a Senior Director Clinical Operations in our Cambridge office.
Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. As a Senior Director Clinical Operations working on the Clinical Operations team, you will be empowered to build and lead a team of Clinical Operations professionals and will oversee the strategy for implementation and execution of all sponsored clinical trials within Aegerion’s clinical pipeline. In this role you will focus on:
- Ensuring that clinical stage programs achieve program objectives within established timelines, budget and quality standards
- Partnering with functional leaders to ensure that the appropriate company infrastructure and quality systems are in place to support all clinical trials.
- Lead the execution of the clinical studies in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines and Aegerion SOPs.
PRIMARY RESPONSIBILITES INCLUDE:
- Directing the building of department infrastructure, including developing, training, and retaining the clinical operations team; ensures prioritization of activities and resourcing is in line with clinical development programs.
- Leading and directing the clinical operations team responsible for management and execution of all clinical trials. This includes but is not limited to, ensuring cost, quality and timeliness of multiple programs is met.
- Creating and maintaining clinical operation department goals, budget, training matrix, and study priorities.
- Providing strategic and technical guidance to ensure that clinical trials are properly defined, planned and executed.
TO BE SUCCESSFUL IN THIS ROLE YOU WILL NEED:
- Twelve or more years of experience leading clinical trials execution, both in the USA and Europe.
- A successful track record of managing and developing a clinical operations staff.
- Experience leading clinical trials for rare diseases or multi-therapeutic clinical operations
- Experience managing a study from pre-clinical to clinical phase.
Local Candidates Preferred
WHAT AEGERION CAN OFFER YOU:
- Small company environment where you can make a difference
- Be part of a growing commercial pharmaceutical company with a global footprint
- Full array of benefits including 401(k) match, (50% of first 6%) and an Employee Stock Purchase plan
- Three weeks’ vacation along with 12 holidays
- Free parking or T-Pass reimbursement
Learn more at https://career4.successfactors.com/career?company=Aegerion
Aegerion Pharmaceuticals is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws.
No Phone Calls or Recruiters Please.