Manager- Investigator Initiated Studies (IIS): Innovative Pharma Co., Unique Marketed Products

Manager- Investigator Initiated Studies (IIS): Innovative Pharmaceutical Company (NJ), Unique Marketed Products

 

In this role as Manager- IIS, you will be responsible for multiple managerial aspects of Investigator Sponsored Trials, while working closely with the Brand Medical Director and/or Medical Science Liaison for follow up with the Investigator to ensure IST proposal is complete.  This company is a very successful research-based pharmaceutical company with a diversified, multi-therapeutic list of marketed Rx products.

 

Location: Caldwell, NJ

 

Attractive Feature(s) of this Company: A mid-size Global Pharmaceutical Company leader with multiple approved drugs marketed in the US and abroad in multiple therapeutic areas.A company that offers “the best of both worlds” - a Global Company that is established, profitable, expanding and financially stable—yet is not too rigid or bureaucratic, which offers its people a flat organization structure where they have a lot of responsibility and opportunity to make a real impact. This company has experienced their most financially successful year to date, while continuing to develop new and innovative therapies to fulfill unmet medical needs.Informal work environment with a casual dress policy, flexible hours and very attractive benefits.  Employee focused and family-friendly companies policies.

Specific Responsibilities:The Manager, Investigational Studies is responsible for various aspects of Investigator Sponsored Trials (IST), including tracking and management of drug requests, patient registration forms and contract-mandated milestone payments for existing studies. Responsible for receipt, tracking and management of all new IST proposals, including preparation for IST Review Committee meeting, facilitation of contract discussions with Bayer legal and new study start up activities. Receives IST submissions from on-line system and prepares for presentation to the IST Review Committee.Works with the Brand Medical Director and/or Medical Science Liaison (MSL) for follow-up with Investigator to ensure IST proposal is complete.Attends IST Review Committee Meetings (schedules meetings, records outcomes and distributes minutes).  Performs follow-up on studies, including negotiations with Investigators, process drug requests, tracking study progress and payments.Liaises with Legal (contract negotiations, Letters of Agreement and compliance issues).Maintains open dialog with Investigators during trials.Responsible for daily management of IST brand budget.Generates management reporting regularly or as needed.

Requirements: BA/BS degree with 6 years of experience in a healthcare field of which 2 years include pharmaceutical experience in study management or clinical research.Experience in the set up and management of clinical trials strongly preferred.

 

Contact:

Brian C. Skurka

 

Cornerstone Search Group, LLC

9 Sylvan Way

Parsippany, NJ 07054

bskurka@cornerstonesg.com (initial contact via email is preferred)

Phone: 973-656-0220



Web/URL: www.cornerstonesg.com

 

About Cornerstone Search Group, LLC:

 

CORNERSTONE is a specialty pharmaceutical recruiting firm located in the heart of New Jersey's Pharmaceutical Corridor. We help our clients hire experienced pharmaceutical professionals from the Staff through Management (VP/Director) levels for Full-Time and Contract positions. We provide our professional recruiting services on a Retained, Contingency or Project basis, as well as offer our clients Outsourced Recruiting services and Strategic Advisory Services on recruitment strategies and talent retention.

 

Building better companies.  Building better careers.®