Assertio Therapeutics, Inc.

Director, Clinical Operations

Location
Lake Forest, IL, United States
Posted
Oct 09, 2018
Ref
3220352
Hotbed
BioMidwest
Required Education
Bachelors Degree
Position Type
Full time
Overview

The Director, Clinical Operations will have strategic planning and oversight over program/s while assisting in the execution of clinical protocols utilizing a strong understanding of FDA regulations and ICH guidelines. The Director, Clinical Operations will work closely and collaboratively with cross-functional representatives, to ensure successful completion and execution of all clinical activities/project deliverables within the established budget and timelines in conformance with Good Clinical Practices (GCP), International Conference of Harmonization (ICH) Guidelines, regulatory requirements and SOPs. The Director, Clinical Operations will also have direct oversight in the management of contract research organizations (CROs) and other third party vendors. The Director of Clinical Operations is also responsible for leading or contributing to company process improvement initiatives. The Director of Clinical Operations will have supervisory responsibilities as applicable. ESSENTIAL JOB FUNCTIONS• Leads and directs 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.• Oversees budgets for study(s) and other clinical activities that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Company financial goals • Responsible for project start-up activities including but not limited to: site feasibility, site selection/recommendation, and regulatory preparation in conjunction with relevant departments.• Monitor performance of investigational sites; prepare or review visit reports.• Ensure studies are carried out according to the study protocol, applicable SOPs, and ICH/GCP regulations and study-specific manuals and procedures. • Ensures documentation and plans are consistent with the protocol and whether prepared inhouse or by a CROs, are completed in accordance with applicable GCP/ICH and regulatory requirements.• Tracks and reports on study progress and key study metrics.• Reviews and approves the EDC system, study manuals, study plans and other study related materials.• Perform clinical data review of data listings and summary tables. Generate queries as necessary. • Oversee discrepancy management, ensure queries are appropriate and responses are timely.• Manage study drug accountability, shipments, reconciliation and return process.• Reviews invoices from sites, CROs and third-party vendors to ensure work has been completed satisfactorily prior to payment.• Provides support in the development of clinical protocols, SAPs, consent forms, and other program/study related documents.• Manages relationships and establishes strong partnerships with CROs, vendors, investigators and other external partners.• Works with the Head of Clinical Operations, legal, and finance (as well as other cross-functional team members as necessary) in the selection of CROs and other third party vendors.• Member of cross-functional clinical trial teams (internal and external) representing Clinical Operations.• Directly supervises employees.• Able to present material and create presentationsADDITIONAL RESPONSIBILITIES/DUTIES • Excellent interpersonal skills, with a demonstrated ability to work in a team environment or independently, are required• Monitoring of clinical investigational sites (including PSSVs, SIVs, IMV, COV, co-monitoring and audit related activities). • Ability to write/edit clinical study documents in a coherent and complete manner. • Other duties as assigned.
Responsibilities
EDUCATION AND EXPERIENCE • Science background BS or healthcare degree preferred• Minimum 2 years of direct supervisory experience• 12+ years clinical experience in a pharmaceutical/biotech or CRO setting with a strong understanding of functional area responsibilities associated with the clinical development and trial process• Experience managing all phases of clinical trials• Experience working in a fast paced environment with limited resources• Experience managing CROs and vendors and monitoring their performanceSKILLS AND ABILITIES• Ability to effectively work within cross-functional teams• Excellent interpersonal, organizational, and multi-tasking skills• Strong knowledge and understanding of GCP/ICH Guidelines and regulatory requirements for conducting clinical trials• Experience with Electronic Data Capture systems• Ability to use MS Programs (e.g. Word, Excel, Outlook etc.)
Requirements

THE COMPANY

Assertio Therapeutics is a leading specialty pharmaceutical company committed to putting the Patient First in everything we do; with a focus on enhancing the lives of patients, families, physicians, providers and in payors through commercialization of products in the areas of neurology, specialty and orphan drugs in areas of unmet medical needs.

Assertio currently markets three medicines focused on neurology and migraine through its Neurology Business and has an emerging Specialty Business focused on orphan drug indications and areas of unmet medical need.

Assertio has a clear THREE PILLAR strategy for growth:

MAINTAIN a strong/profitable NUCYNTA franchise through a commercialization agreement with Collegium, GROW the Neurology Business and BUILD a new Specialty Business through a recent Cosyntropin transaction. The company's strategy is to continue to identify, license and develop new products-that offer enhanced therapeutic options to patient populations that may be underserved by existing therapies.

Assertio is an AA/EEO/Veterans/Disabled employer.