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Director, Clinical Trials

Therapeutic Proteins International, LLC

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Location: Chicago, IL Posted Date: 4/25/2013 Position Type: Full time Job Code: DCT002 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management
Regulatory Affairs

Description

Therapeutic Proteins International, LLC (TPI) is a world-class developer and commercial manufacturer of finished biosimilar recombinant therapeutic protein products. TPI's products are manufactured in cGMP/BLA compliant facilities using proprietary
and patented technologies for both mammalian and bacterial expression systems at globally competitive cost. Located in the heart of Chicago, TPI is supplying the US FDA approved biosimilar cytokines and monoclonal antibodies globally to help reduce
the cost of treatment to patients worldwide.

SUMMARY:

The Director, Clinical Trials will be responsible for the successful execution of Clinical Trials when outsourced to strategic CRO partners and Clinical Trial Management infrastructure deliverables. This individual will work in partnership with each of the Therapeutic Area Medical Directors, Regulatory, Biostatistics, Research Directors and, critically, external partners. As a leader within the organization, the incumbent will be instrumental in the concept, design, growth and deliverables of the clinical trial management function as it relates to external partnerships to assure the highest quality delivery of Clinical Programs, on time and within budget.

JOB RESPONSIBILITIES INCLUDE:
•   Support the Vice President, Regulatory & Clinical Trials, in clinical trial execution with external partners
•   Act as operational lead for relationships with CROs where a strategic partner is in place
•   Be responsible for coordinating Joint operations committees on behalf of TPI with strategic partners including agendas, minutes, follow-up on action items
•   Achieve clinical trial program execution within budget, on time, and of the highest quality, through cross-company and cross-partnership collaboration
•   Identify and communicate clinical development risks and mitigation strategies as they relate to strategic partners
•   Partner with the organization to optimize cross-functional communication
•   Act as a lead for process optimization between CRO partners and TPI
•   Assess and allocate resources for clinical projects; establish a systematic scalable approach for future project and portfolio enhancement based on risk management principles
•   Support integration of TPI and CRO teams and process to enhance success of new collaborations

Requirements

Education

Advanced Degree in science or equivalent combination of relevant educational and professional experience is required.

Experience

•   University degree and 5 to 10 years related experience in the biotech field either in-house or in a CRO.
•   Experience and success in a clinical project/trial management role within another biotech or pharmaceutical company.
•   Strong leadership, project management, and negotiation skills are required.
•   Knowledge of advanced computer systems for Clinical Trial Management and data management.
•   Knowledge of ICH/GCP guidelines.
•   Knowledge of FDA and EMEA structure and operation, drug development and commercial needs, and full command of laws, regulations and guidance is required.
•   Must be solution-oriented, open-minded, with extensive knowledge of regulations and drug development.
•   Experience writing protocols related to testing of Biological products.
•   Experience taking protocols through the USFDA process.
•   Excellent written and verbal communication skills.
•   Must have keen attention to detail and quality.

TPI, LLC does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on TPI’s approved agency list. Unsolicited resumes or candidate information submitted to TPI by search/recruiting agencies not already on TPI’s approved agency list shall become the property of TPI, LLC and if the candidate is subsequently hired by TPI, TPI shall not owe any fee to the submitting agency.

TPI, LLC is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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