current openings

Associate Director Clinical Operations

Associate Director Clinical Operations

This position will be responsible for the conduct of assigned clinical programs in accordance with Good Clinical Research Practice guidelines and consistent with applicable regulations and policies.   The position will have the following responsibilities associated with the programs:

• Oversight of clinical trial management and Clinical Research Organization (CRO) selection, management and performance
• Preparation, management and revision of all Investigational Plans (including study protocol, Instructions For Use [IFU]), reporting of prior investigations, bibliograpy, Case Report Forms (CRF), and other appropriate sections of the IND  in consultation with the cross-functional project team, investigators, data management and biostatistics
• Management of review and approval of relevant clinical documents
• Supervision of training for investigators, site staff, clinical staff and supervision of site initiation, monitoring and closeout activities
• Oversight of setup and maintenance of accurate study status and logs
• Interface with representatives from key functional groups (R&D, Manufacturing, Sales & Marketing, Regulatory Affairs and Quality) to drive clinical-wide or cross-departmental initiatives
• Development, forecasting and management of cost center budget and study budgets
• Ensure that appropriate resources and priorities are maintained for the various projects assigned to each area of expertise
• Support management interface with regulatory agencies as appropriate
• Compile, review and resolve all clinical complaints
• Management level representation during all audits
• Assist data management group with review of clinical data/information; oversight for data correction
• Participation in the preparation of technical and scientific publications and author results of studies for medical literature and/or presentations at conferences
• Completion of projects and activities in a manner consistent with corporate objectives including timeliness
• Ensure studies, where agreed, are properly listed and maintained in the ClinTrials.gov database.
• Provide early warning of clinical sites not meeting expectations, i.e. slow enrollment, randomizing patients who should have been excluded, etc., and work with the site to correct issues or if needed recommend that the site be discontinued

In addition to the above project related responsibilities:

• Assist in clinical department SOP review and development
• Assist in interviewing and recruiting potential candidates for the group
• Learn and follow all MicroDose policies and procedures

Other:

• Requisite education, knowledge and experience will be required to be considered for this position

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Senior Level Scientist

Senior Level Scientist

This position will be responsible for the testing and data analysis of the Company’s inhalation products; may also have responsibility for junior level scientific staff.

Experience Required

Five to ten years experience required in the following areas:

• Development and testing of pulmonary drug delivery systems (DPI)
• Test procedures common to pulmonary delivery systems including     Cascade Impactor, air flow measurement, HPLC analysis  (Waters, Empower)
• Calculating key measures of in-vitro aerosol performance such as     MMAD, fine particle fraction, emitted dose, analysis of dosage forms
• General laboratory procedures including extractions, preparation of     standards
• Work in GLP/QC/GMP environment
• Preparing and following study protocols, SOPs
• Reporting of data in written, graphical and tabular formats (proficiency in Excel)
• Interpretation and preparation of study reports including familiarity with statistical techniques commonly utilized to analyze laboratory data
• Work with statistical tools to evaluate data sets
• Working knowledge of MS Project
• Proficient in lab notebook management
• Team leadership (i.e. some type of supervision of junior staff)

Attributes

Candidates will possess the following attributes:

• Superior analytical and problem solving proficiency
• Original and creative thinking
• Excellent communication skills (verbal and written)
• Strong work ethic
• Dedication to work and team

Acedemic

In addition to in-depth experience and knowledge in relevant areas, candidates for consideration will have fulfilled the following academic requirements:

• BA, BS or MA, MS in Chemistry  (or PhD)

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Senior Level Mechanical Engineer

Senior Level Mechanical Engineer

This position will be responsible for the design and development of the company’s inhalation products.   The position may also be responsible for the management of junior level engineering staff.

Experience

Minimum of eight years experience required in the following areas in the Pharmaceutical or Medical Device industry:

• Mechanical design and analysis
• Materials selection
• Design controls, ideally with ISO 13485 experience
• Working in product development environment (preferably Dry Powder Inhalers and/or small, handheld electro-mechanical medical devices)
• Proficiency in designing, conducting and reporting mechanical validation/verification testing
• 3D CAD (Solidworks)
• Writing protocols and reports

Experience/talent in the following areas preferred:

• Electro-Mechanical hand-held devices
• Machine design
• Machine control systems
• DOE; ANOVA

Attributes

Candidates should possess the following:

• Superior problem solving skills
• Original and creative thinking
• Ability to work independently
• Dedication to work and co-workers
• Team player
• Excellent communication skills – written and verbal

Academic

Academic credentials:

• Mechanical Engineering degree required
• Advanced degree considered a plus

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Nancy Wolman, Director, Human Resources

MicroDose Therapeutx
4262 US Route One
Monmouth Junction, NJ 08852
Phone: 732 355 2100
Fax: 732 355 2101
email: nwolman@mdtx.com