Positions currently available Email resumes to: Dee Grosso, Executive Director, Human Resources: dgrosso@transaveinc.com

Sr. Clinical Project Manager Sr Director/Director Clinical Research & Operations Director Of Quality Assurance

No resumes from recruiters/agencies will be accepted at this point in time.

Sr. Clinical Project Manager

Description:

• Responsible for all aspects of clinical study planning and execution within pre-specified program plan, timelines and budget and includes, but is not limited to, preparation of study related materials, relationship management between study sites and vendors especially CRO, supervision of study related activities, , identification of project risks and contingency planning. Provides overall cross-functional leadership to achieve project objectives on time, within budget and with high customer satisfaction. Will handle CF, Phase 3 trials for 108,109, 110 and assist with regulatory.

Specific Responsibilities Include:

• Manage integrations of all project team activities
• Responsible for the execution of a clinical development program from protocol design to the final clinical study report for one or several studies
• Responsible for coordinating all efforts for the trial both within Transave and through a wide variety of CRO and vendors
• Develop contingency/risk management plans for projects and assist Director of Operations in the preparation and execution of sound development strategies
• Track and manage project actual costs vs. budget (keep track of specific items/details in the budget and know whether expenses are on target)
• Interface with Finance acting as a liaison between Clinical and Finance
• Responsible for budget and forecast preparation for clinical studies
• Reviews and approves vendor invoices for payment and codes invoices
• Provides a variance analysis of budget to actual and notifies Finance of projected cost overruns/under-runs
• Manage contract research organizations
• Manage study sites
• Manage tracking systems for drug supply and use, enrollment of subjects, regulatory document flow, study timelines, financial information, Serious Adverse Events, performance metrics, data flow, etc.
• CRF and ICF review
• Travel will be about 10 – 20%

Qualifications:
Education/Professional Skills & Experience

• Manage integrations of all project team activities
• Responsible for the execution of a clinical development program from protocol design to the final clinical study report for one or several studies
• Responsible for coordinating all efforts for the trial both within Transave and through a wide variety of CRO and vendors
• Develop contingency/risk management plans for projects and assist Director of Operations in the preparation and execution of sound development strategies
• Track and manage project actual costs vs. budget (keep track of specific items/details in the budget and know whether expenses are on target)
• Interface with Finance acting as a liaison between Clinical and Finance
• Responsible for budget and forecast preparation for clinical studies
• Reviews and approves vendor invoices for payment and codes invoices
• Provides a variance analysis of budget to actual and notifies Finance of projected cost overruns/under-runs
• Manage contract research organizations
• Manage study sites
• Manage tracking systems for drug supply and use, enrollment of subjects, regulatory document flow, study timelines, financial information, Serious Adverse Events, performance metrics, data flow, etc.
• CRF and ICF review
• Travel will be about 10 – 20%

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Sr Director/Director Clinical Research & Operations

Description:
Responsible for all aspects of the Clinical Research and Operations successful submission of NDA and MMA for 2 indications which are global operations.

Specific Responsibilities Include:

• Sponsor responsibility for execution of Phase III programs
• Provide leadership and oversight for the development operations team for on-time, on-budget, in full compliance (GCP, etc) of programs
• Manage global clinical trials
• Management of Phase III trials according to ICH, GCP and FDA requirements
• Clinical project management, including the selection of vendors, and the selection and interface of CROs
• Monitoring the progress of trials including enrollment and resource allocation and utilization
• Manage all budgets and provide progress updates to management
• Protocol development
• Investigator recruitment
• Development of consent forms and IRB materials
• Operating plans
• Randomization and clinical drug supply plans
• Case report form development and electronic data capture
• Data cleaning and database locking
• Coordinate development of statistical analysis plans
• Clinical studies report development
• Development and observance of internal SOPs related to trial management
• Supervision of clinical research associates (CRAs)
• Organize and lead project sub-team and CRO meetings as necessary
• Work closely with clinical research, preclinical research, manufacturing, quality assurance, and regulatory affairs in the execution of the clinical development program

Qualifications:
Education/Professional Skills &Amp; Experience

1. Licenses, certifications and degrees:
   (Note: include academic degrees only if absolutely a job requirement.)
   MS/PHD in biological sciences is required; or in a nursing degree or equivalent experience.
2. Role-related knowledge:
   
   • 10-15 years of clinical research and operation experience
   • Must have Phase III experience including submission of NDA and MMA ; will handle CF so knowledge in this area and/or Respiratory is a plus
   • Experience of GCP/ICH guidelines and FDA regulations
   • Experience with clinical trial design and data management required and basic knowledge of statistics is preferred
   • Experience managing budgets for Phase III programs including oversight of CROs
3. Role-related (skills, abilities, behavior necessary to perform the role) including language, mathematical and reasoning (analytical) skills, intellectual, creative and/or communications abilities:
   Must have demonstrable Leadership skills and be a team player with good organization skills and the ability to prioritize. Seasoned negotiating skills are required and the candidate must possess the ability to work with individuals from multiple groups to resolve conflicts and persuasively influence outcomes. Prior management experience and proven ability to coach and mentor team members is required. Strong oral and written communication skills are required. Must be able to thrive in a fast paced business environment and be a self-starter, detail-oriented, and motivated, with a commitment to excellence in research.

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Director Of Quality Assurance

Description:
Oversee and ensure all facets of Quality throughout the company.

SPECIFIC RESPONSIBILITIES:

• Establish and maintain a risk-based and scientific-based quality system.
• Through a quality system approach, ensure all GMP operations are in compliance, while maintain an efficient workflow to facilitate the operational excellence.
• Provide leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development as appropriate. By improving individual performance and group collaboration, the Director will be responsible for improving the overall department productivity and efficiency.
• Oversee, and be ultimately responsible for, the Company's quality assurance program. This includes overseeing and assisting with the Company's training and auditing programs, as well as the review of SOPs, investigations, deviations protocols, specifications, methods, validation reports, cleaning verification reports, analytical reports, and manufacturing records.
• Along with the QA associates, be responsible for the release or rejection of GMP materials.
• Prepare, review, and approve external and internal reports and other documentation required by regulatory agencies, customers, or to support the quality assurance function.
• Act as company's representative during regulatory agencies and customer inspections.
• Identify and lead operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality department.
• Audit the manufacturing and testing facilities of vendors, customers and outside contract organizations. Implement Processes and Systems to assure Sponsor responsibility for regulatory compliance with GMP, GLP and GCP.

QUALIFICATIONS:
Education/Professional Skills & Experience

1. Licenses, certifications and degrees:
   (Note: include academic degrees only if absolutely a job requirement.)
   Minimum BS degree in Chemistry, Life Science, or related discipline. MS, PhD, MBA preferred, or equivalent experience.
2. Role-related knowledge:
   Full understanding of cGMPs, GLPs, and GCPs. Understanding of FDA inspection procedures. Familiarity with pharmaceutical product manufacturing and testing processes. Experience with Phase I through IV, and in particular, Phase III and experience with Regulatory approval, NDAs and MAAs.
3. Role-related (skills, abilities, behavior necessary to perform the role) including language, mathematical and reasoning (analytical) skills, intellectual, creative and/or communications abilities:
   
   • 10-15 years Quality Assurance experience in regulated industry such as pharmaceuticals, or biologics is required.
   • Experience with effectively managing FDA inspections, working with regulators, and customer audits required.
   • Experienced at writing manufacturing and laboratory investigations is essential.
   • Experience with risk based decision making tools highly preferred.
   • Broad knowledge of cGMP, ISO requirements for pharmaceuticals
   • Demonstrated ability to manage staff and variable workloads

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Transave is establishing talented, world-class teams in several functional areas including preclinical development, analytical R&D, clinical development, marketing and finance.