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Miles
Km80.5

Vice President, Regulatory Affairs & Clinical Trials

Therapeutic Proteins International, LLC

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Location: Chicago, IL Posted Date: 4/25/2013 Position Type: Full time Job Code: VPRAC003 Required Education: Bachelors Degree Areas of Expertise Desired: Clinical Data Management
Regulatory Affairs

Description

Reporting to the President, the Vice President, Clinical and Regulatory Affairs (VPCRA) is responsible for the overall management of the clinical drug development programs of a Midwest biotechnology company and its regulatory processes.
The VPCRA will provide management and leadership for the operational design, implementation, and execution of clinical trials including day-to-day management of CROs, project managers, clinical supplies management, and data management. This position also directs, manages, and oversees regulatory activities in support of corporate objectives, and develops and executes strategies for the earliest possible approvals of biosimilar products.
Salary and benefits are competitive and commensurate with qualification.
MAJOR RESPONSIBILITIES:
Clinical
•   Direct and manage the company’s clinical research operations from initiation through delivery.
•   Responsible for CRO and vendor selection for individual trials as well as the development and implementation of metrics to ensure the quality and timeliness of deliverables.
•   Overall responsibility for the provision of data to be used in various reports.
•   Liaise with program management to ensure clinical staff and mitigation solutions implemented as necessary proactively identify risks.
•   Lead contract negotiations with CROs, manage external supplier relationships and manage all aspects of CRO activities to ensure that they are performed in line with the contract and expectations.
•   Overall responsibility for Clinical Operations budget, invoice approval, contracts negotiation with sites, vendors, and consultants.
•   Build and maintain relationships with vendors, sites, investigators, clinical advisors and key opinion leaders as well as internal communication with both operational and business support groups.
Regulatory
•   Direct and manage all regulatory submissions and communications to regulatory authorities. Ensure timely preparation of organized and scientifically valid submissions. Evaluate need for external expertise for submission and together with project leads, manage and coordinate external input.
•   Develop integrated regulatory strategies for global filings, in collaboration with other departments, to expedite the conduct of trials and registration for each product.
•   Identify issues that may increase regulatory and corporate risk, and propose informed strategies to address such risks.
•   Maintain knowledge and familiarity with the regulatory environment and latest regulatory issues. Provide expertise in translating regulatory requirements into practical, workable plans and communicate requirements to other departments and multidisciplinary teams.
General
•   Ensure that clinical and regulatory projects are completed on schedule and within budget.
•   Prepare reports and keep senior management informed of progress and problems.
•   Clinical and regulatory operations’ budget responsibility.
•   Evaluate in-license candidates as needed. Serve as clinical and regulatory lead for out-licensing due diligence activities.
•   Oversight of projects and people in order to identify risks and determine appropriate mitigation strategies to proactively address emergent issues.
•   Assist in developing strategies to meet corporate goals.
ADDITIONAL RESPONSIBILITIES:
•   Establish and maintain industry contacts
•   Ensure clinical research and regulatory strategies, policies, and procedures are maintained.
•   Works closely with all operational groups (medical, CMC, quality, program management, corporate communications, finance) in order to ensure coordination of timelines and deliverables.
•   Identify, attend key meetings, seminars, and conferences in order to promote business opportunities, network and identify business growth and funding opportunities.
ACCOUNTABILITIES:
•   Quality of data to be used for registration and partnering initiatives.
•   Adherence to timelines and budgets as communicated to the Board and shareholders.
•   Develop and execute regulatory strategies that will expedite product development while minimizing cost.
•   Identify issues that may increase regulatory and corporate risk, and propose informed strategies to address such risks.
•   Ensure that all submissions are of the highest possible quality and serve to further product development.

Requirements

MINIMUM QUALIFICATIONS:
Technical Knowledge/Experience
•   University degree and 5 to 10 years related experience in the biotech field either in-house or in a CRO.
•   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.
•   Hands-on experience with preparing, filing, and securing approval of BLAs or biosimilar products approval is most desired.
•   Must be solution-oriented, open-minded, with extensive knowledge of regulations and drug development.
•   Excellent written and verbal communication skills.
•   Must have keen attention to detail and quality.
Behavioral
Demonstrated ability to apply the following behavioral competencies on the job:
•   Relationship Building: Ability to develop, grow and maintain business relationships
•   Innovation: Creative thinker
•   Teamwork: Working effectively and productively with others
•   Decision Making: Utilizing effective process to make decisions
•   Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
PREFERRED QUALIFICATIONS:
•   Experience in biologics clinical development and regulatory affairs in autoimmune disorders, cancer treatment and metabolic space
•   Track record of positive FDA interaction
•   Graduate education is preferred
•   Post-graduate training in Regulatory Affairs is an asset
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