Blend Therapeutics is discovering and developing novel combination medicines with the unprecedented ability to precisely control each agent’s therapeutic action in concert. Using our proprietary Maestro™ technology platform, we design and integrate drugs to target distinct disease pathways with optimal efficacy and safety. Our goal is to introduce a new generation of best-in-class medicines that achieve the full potential of combination therapy to address complex diseases.

To achieve this goal we are building internal capabilities in biology, synthetic and polymer chemistry, materials science, formulation design, process development, and analytical chemistry. We seek candidates from diverse backgrounds who are passionate about developing integrated, mechanistically engineered combination medicines that will result in important drugs for the treatment of cancer, inflammation/pain, and infectious diseases.

We seek a scientist to further our ability to optimize in vitro and in vivo pharmacology of combination products using both internal and external resources.

Successful candidates will have the following credentials:

• Strong scientific foundation demonstrated by continuing activity in the scientific community (publications, presentations, symposium/conference coordination)
• Track record of using a mechanistic approach to problem-solving
• Successful execution of innovative ideas
• Impactful contributions on project teams
• Delivering results to meet timelines
• Experience with managing contract research organizations
• Effective communication to individuals, teams, and executives

Blend was founded by Omid Farokhzad (Harvard Medical School), Robert Langer (MIT), and Stephen Lippard (MIT): leaders in the fields of nanomedicine, drug delivery, and medicinal chemistry. Blend is backed by Flagship Ventures, NEA, and NanoDimension, who have an outstanding track record for creating hugely successful biotech companies.

Blend Therapeutics is discovering and developing novel combination medicines with the unprecedented ability to precisely control each agent’s therapeutic action in concert. Using our proprietary Maestro™ technology platform, we design and integrate drugs to target distinct disease pathways with optimal efficacy and safety. Our goal is to introduce a new generation of best-in-class medicines that achieve the full potential of combination therapy to address complex diseases.

To achieve this goal we are building internal capabilities in biology, synthetic and polymer chemistry, materials science, formulation design, process development, and analytical chemistry. We seek candidates from diverse backgrounds who are passionate about developing integrated, mechanistically engineered combination medicines that will result in important drugs for the treatment of cancer, inflammation/pain, and infectious diseases.

We seek a scientist to be part of a group that integrates materials science, formulation design, and process development in the manufacture of novel drug combination products, from preclinical research through clinical development to process validation.

Successful candidates will have the following credentials:

• Strong scientific foundation demonstrated by continuing activity in the scientific community (publications, presentations, symposium/conference coordination)
• Track record of using a mechanistic approach to problem-solving
• Successful execution of innovative ideas
• Impactful contributions on project teams
• Delivering results to meet timelines
• Experience with managing contract research organizations
• Effective communication to individuals, teams, and executives

Blend was founded by Omid Farokhzad (Harvard Medical School), Robert Langer (MIT), and Stephen Lippard (MIT): leaders in the fields of nanomedicine, drug delivery, and medicinal chemistry. Blend is backed by Flagship Ventures, NEA, and NanoDimension, who have an outstanding track record for creating hugely successful biotech companies.

Blend Therapeutics is discovering and developing novel pharmacological agents by utilizing our Maestro™ platform to integrate drug design, nanoparticle engineering and combination therapies. We are developing proprietary drug candidates to be used as single agents or integrative drug combinations to transform the treatment of a range of complex diseases.  To achieve this goal we are building internal capabilities in biology, medicinal and polymer chemistry, materials science, formulation design, process development, and analytical chemistry. We seek candidates from diverse backgrounds who are passionate about developing integrated, mechanistically engineered medicines that will result in important drugs for the treatment of cancer, inflammation/pain, and infectious diseases.

We are seeking an experienced medicinal chemist to help build Blend’s medicinal chemistry capabilities through creative problem solving and inventing new chemical entities by leveraging sophisticated molecular design and synthetic chemistry skills.

Successful candidates will have the following credentials:

• Successful track record in advancing medicinal chemistry programs
• Demonstrated skills in creative problem solving
• Ability to critically assess program issues, design novel molecules and execute sophisticated synthetic schemes
• Demonstrated track record of achievement in organic chemistry
• Must have a passion for working in the chemistry laboratory
• Experience in developing scalable chemical routes & route selection
• Ability to work alone & in a team environment
• Must be proficient in modern analytical techniques
• Excellent communications skills required
• Ph. D. with 2-6 years of industrial experience
• Strong scientific foundation demonstrated by continuing activity in the scientific community (publications, presentations, symposium/conference coordination)

Blend was founded by Omid Farokhzad (Harvard Medical School), Robert Langer (MIT), and Stephen Lippard (MIT): leaders in the fields of nanomedicine, drug delivery, and medicinal chemistry. Blend is backed by Flagship Ventures, NEA, and NanoDimension, who have an outstanding track record for creating hugely successful biotech companies.

 The Point of Care (POC) Installation and Support Specialist will provide current end users with top level telephone support for our meter management software, middleware connection, and ADT and LIS connections, provide post implementation connectivity support and training and on-going system maintenance, provide remote installation of Nova POC meters and management software on customer servers or P/Cs and provide setup instructions for meters and network communication validation as well as software and meter configuration training. When customer systems require, the POC Installation and Support Specialist will coordinate with vendor partners for the interfacing of Nova meters and software onto middleware data and interface management platforms and coordinate and install Nova software upgrades as well as assist the Implementation Managers with on-site connectivity installation support.   Requirements:  A BS in a technical discipline or equivalent work experience.  Minimum of 2 to 4 years experience with bedside Glucose testing and POC and/or Lab experience involving data management.  Experience in Windows XP and 7, Server 2003 and 2008 operating systems, and solid TCP/IP networking understanding.  Experience utilizing remote access software including Cisco VPN, Citrix, and others is a plus.  A working knowledge and understanding of Web Interfaces, Relational Databases, as well as an understanding of EDI, Serial and scripted interfaces.  Excellent presentation, training and communications skills as well as the ability to work as part of a team and independently.  Solid multitasking is essential for success in this position.  Healthcare IT and Point- of-Care professionals will be strongly considered. 

The Quality Assurance Technician will perform inspection of meters, labeling, and packaging, validation of hospital meters, data processing and release testing of test strips and control solutions.  The technician will work with the supervisor and group leaders to resolve discrepancies.  Other duties include data entry, filing, maintenance and calibration of instruments, inventory/supply ordering, and record keeping.  Shift is 7 AM – 4 PM.   Requirements:  Associate or higher in Biology, Medical or Life Sciences degree, 1-3 + years Lab Technologist and/or clinical laboratory experience, knowledge of good laboratory techniques and practices and experience with handling blood, must be proficient with statistics and Microsoft Excel.

The Quality Control Manager, a hands-on problem solver will manage the quality control function in the Waltham, MA facility to drive quality improvements and continuous improvement efforts associated with the quality of products and the processes and testing of analyzers and reagents.  Additional responsibilities include the drive the current quality control practices of testing, data collection and reporting, ensuring compliance to FDA and ISO requirements, analyze and act upon quality reports and quality database, collect, summarize, and post data on quality metric performance, support engineering and manufacturing quality improvements with procedures, processes and quality engineering tools with data and statistics to gauge effectiveness of improvements, and ensure compliance to customer requirements. Requirements:  BS degree in a technical discipline, preferably life sciences or medical technology with 8+ years of Medical Device/IVD experience.  Prior experience as a Quality Control Manager in an FDA regulated reagents, medical device or IVD manufacturing company, strong working knowledge of ISO 13485, IS9001 and FDA Regulations (21 CFR Part820).  A thorough understanding of quality improvement tools, i.e. Six Sigma and Lean Manufacturing along with a strong knowledge of statistical methods including statistical process control and sampling techniques.  Other requirements include:  a demonstrated failure analysis experience working with cross-functional groups to determine root cause, excellent communication skills and the ability to work well under pressure with cross functional teams.  Strong MS Office skills.  ASQ Certified Quality Manager, quality engineering, Six Sigma Certification is/are a plus. 

 The Software Quality Assurance Tester will participate in the software validation processes for computer controlled medical devices.  Specific duties include: create and execute software test plans and procedures using a formalized software development life cycle compliant with FDA regulations, ensure all validation issues are properly tracked, and modify existing SQA documents as needed. Requirements: 3-8 years experience working in SQA activities for medical device development and manufacturing, Associates Degree preferred.

The BioProfile Technical Application Specialist will provide escalated technical application and product support of the BioProfile products to the industry’s leading pharmaceutical and biotechnology companies.  Responsibilities include: address product application issues, provide applications support for product integration into small-scale development labs, pilot facilities, and GMP manufacturing facilities.  Additional responsibilities include: Conduct in-house BioProfile customer training, facilitate product trending, communicate with R&D and Manufacturing to resolve product and technical performance issues, and provide customer support for customer specific application issues.  Other responsibilities include: work closely with new customers to streamline validation requirements on BioProfile products to ensure a successful, smooth transition to Nova technology as well as educate end users on instrument specifications; operation and maintenance, perform data analysis in support of various applications, design and implement onsite customer correlation, and statistically design product evaluations and IQ(Installation Qualification)/OQ’s(Operational Qualification) as well as act as a resource to field support peers.  Requirements:  BS in Biology or a life science field with 2 to 3 years of experience in biotech/pharma working in process development and/or a GMP controlled manufacturing or research environment.  Experience with mammalian cell culture or bacterial fermentation is needed and experience in antibody assay development and characterization is a plus.  Up to 35% travel.

Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patients best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity is a small but fully integrated drug discovery company with capabilities ranging from early discovery to clinical sciences.

Description:

This is a key support role to senior Clinical Operations staff.  The individual will ensure that delegated components of clinical trials are executed to expected and specified quality standards. They will build basic knowledge of clinical trials operations, and scientific principles and objectives of Infinity’s clinical trials under some direction and guidance of senior staff, but largely self-directed.  The individual will work independently, but know when to involve / collaborate with others.  They will learn best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations.

Role accountabilities

•  Ensures an understanding of clinical trial protocols and site specifications and the scientific/medical objectives of the clinical trials
•  Verifies that data collected in trials is consistent with protocols
• Reviews monitoring reports, checks for adherence to trial metrics, and assesses sites against clinical trial protocol specifications

Responsibilities:

Quality:

•  Ensures patient enrollment activities are within protocol guidelines; recognizing that this needs to be managed well
•  Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Project Manager or senior Clinical Operations staff
•  Acts as QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for Infinity studies
•  Fully understands the need for and  importance of being inspection ready and diligently follows Infinity Clinical Operations SOPs; identifies and communicates if there are gaps
•  Accountable for ensuring that meeting agendas are clear and distributed in advance; takes comprehensive and precise minutes for internal and external meetings.
• Accountable for study level tracking as assigned by the Clinical Project Manager; e.g. monitor visit tracking and sample tracking
• Plays a primary role in sample collection and analysis process at the study level
• Provides study level information to enable accurate and efficient supply of clinical product to the sites
• Adheres to project management processes and SOPs
• Actively participates in the development of department initiatives; contributes ideas  when asked on department initiatives and goals that will make a difference to the efficiency and effectiveness of Clinical Operations

Timelines:

•  Communicates and coordinates with senior Clinical Operations staff/management to ensure accurate and comprehensive completion of documents needed by Regulatory Affairs; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines
•  Under the guidance and direction of the Project Manager and/or Clinical Operations management, interfaces with other Infinity functions  to coordinate relevant and timely exchange of information / materials to support clinical trials delivery within the drug development process
•  Ensures patient enrollment activities are conducted in a timely manner

Budget:

•  Manages administration of invoice reconciliation, scoping, and change orders, for clinical trial operations

Requirements:

• 2 - 3 years of relevant experience Clinical Operations experience and a BS in a relevant scientific discipline. (MS preferred.)
• Monitoring experience preferred
• Working knowledge and experience of Microsoft packages  
•  Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials
•  Demonstrated ability to learn tools and processes that increase measured efficiencies of the project.
•  Demonstrated ability to manage components of clinical trials with general guidance from senior staff.
•  Demonstrated understanding of interdependencies of data, technology, vendor metrics and differences across vendor abilities and requirements.
•  Strong verbal, written and presentation skills.

To apply please visit our website: www.infi.com/careers-opportunities.asp

• Directs the development, implementation and maintenance of our client's quality systems and activities
• Oversees development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products
• Oversees development and implementation of standards, methods and procedures for inspecting and monitoring the company’s vendors, contractors and consultants
• Responsible for directing, establishing and maintaining quality assurance standards based on internal and external specifications
• Assures that outside vendors, contractors and consultants meet and continuously comply with the company’s quality standards
• Assures that finished products meet government regulations and company standards
• Assures compliance with quality system requirements by conducting audits, training programs, data and documentation reviews and analysis
• Enforces corrective action necessary to assure conformity with quality specifications.
• Reports to the CEO

Experience and Education

• Degree in biology, chemistry or a closely allied field; advanced degree is preferable
• RAC certification
• 10+ years in managing quality systems related to transfusion-related medical products from development to commercial launch (both U.S. and international)

Knowledge and Skill Requirements

• Experience with 21 CFR part 312 (IND), 812 (IDE) and 820 (QSR)
• Familiar with ISO 13485 processes and procedures
• Familiar with the CE Mark system and requirements for medical

Responsible for collecting, verifying, recording, and compiling data and information along with establishing and documenting laboratory procedures to support our client's instrumentation and disposable development.

Primary Tasks and Responsibilities

• Conduct procedures for protocol development and optimization
• Evaluate spray drying results using routine coagulation techniques and ELISA-based assays
• Maintenance and upkeep of the Integration Lab
• Perform duties of Laboratory Safety Officer
• Perform instrument calibrations, quality control, and preventative maintenance
• Manage laboratory logistics including ordering and inventory of supplies
• Ensuring product reliability, manufacturability, serviceability, safety, and quality
• Ensuring product compliance with Quality Systems Regulations
• Development and documentation of testing procedures and reports

Experience

• 8+ years laboratory research, blood bank experience preferred
• Expertise in performing and interpreting laboratory device-based testing and analysis
• Familiarity with coagulation testing; including PT, aPTT, fibrinogen, specific proteins, etc.
• Experience with standard automated coagulation analyzers (e.g., Siemens, Stago)
• Experience with ELISA-based assays
• Experience working in a regulated Quality System environment
• Familiar with OSHA’s Bloodborne Pathogens Standard

Directs the design, scale-up, and technolgy transfer of oligonucleotide and peptide manufacturing chemical processes from the pilot plant through manufacturing scale. Manages the development, implementation, and support of production processes, control methods and equipment to achieve stage appropriate production of clinical trial material and commercial product.

Responsibilities
Participates with other senior managers to establish strategic manufacturing plans and objectives. Works on complex issues where analysis of situations and data requires an in-depth knowledge of process engineering, factors influencing scale up / scale down of critical process parameters and pharmaceutical production equipment. Directs technical project teams to provide innovative solutions to meet project deadlines. Ensures budgets and schedules meet corporate requirements. Implements new process manufacturing and control technology. Develops supports and maintains development report writing systems, development reports, documents and data storage. Directs and maintains team(s) responsible for process scale up and tech transfer of bulk active pharmaceutical ingredients (API) and reagents under current Good Manufacturing Practices (cGMP) in support of proprietary drug development. Provides technical and managerial supervision of Process Engineering and Scale Up function to ensure development and production objectives are achieved. Works in conjunction with Process Development (chemistry) to design stage appropriate API processes and product supply in support the toxicology, clinical, and drug product formulation studies. Manages the outsourcing of API and reagent production when appropriate to meet program needs. Plans and implements the commercial supply chain strategy, and the associated process development and tech transfer, to establish cost-effective commercial manufacturing capabilities within the company and with selected CMOs. Is responsible for the late-stage process development and validation of commercial processes.

Qualifications & Requirements
A minimum of a Bachelors degree in a scientific or engineering discipline is required. An advanced degree is preferred. Equivalent experience may be accepted. A minimum of 10 years experience in the pharmaceutical or other related industry is required. A minimum of 8 years previous management experience, preferably in a process development FDA regulated environment, will be a definite advantage. Must have experience within R&D and/or process development that includes pilot plant, scale up and commercial manufacturing. Must have experience in technology transfer from development into a pharmaceutical production operation. Strong verbal and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Good compliance and safety practices are a must. Must be experienced in working in a team-focused environment. A proven track record in developing and managing process development efforts in both startup and commercial environments is desirable. Must have a thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities. Project management experience is a plus. A proven ability to work within a budget and timeline and provide cost savings is required.

Director of Quality Assurance

T2 Biosystems is disrupting the landscape of clinical diagnostics with T2MR, the Company’s proprietary magnetic biosensor detector. The T2MR technology enables healthcare professionals to save lives and reduce costs by providing sensitive, accurate, and rapid diagnostic results. The company’s products can detect molecular or immunoassays targets and provide a robust menu of hemostasis measurements directly from unpurified clinical samples in hospitals, labs and physicians’ offices. We are seeking a talented and highly motivated individual to join our team as Director of Quality Assurance. You will report directly to the V.P., Clinical, Regulatory Affairs & QA.

Summary: 

• Responsible for directing the quality assurance function in support of worldwide product quality and quality system compliance consistent with T2 Biosystems’ company goals including the direction, planning and execution of quality improvement initiatives.
• Establishes and maintains the Quality System in compliance with QSR, ISO, EN and IVDD regulations. Manages multiple programs, and interfaces with a variety of internal and external stakeholders.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors and creative problem solving techniques.
• Supervises other staff members and participates in basic departmental management.
• Prevents or eliminates defects in new or existing products by performing the following duties personally or through delegation.

Essential Duties and Responsibilities Include the Following: (Other duties may be assigned)

1. Facilitates development of the quality function including setting direction, securing resources, and driving achievement of results.
2. Develops and administers budgets, schedules, and performance standards. Ensures budgets, schedules, and performance requirements are met.
3. Guides the achievement of project deliverables.
4. Supports ISO 13485 and IVDD certification processes and compliance to FDA’s QSR regulations by leading the development, implementation, monitoring, and improvement of quality systems.
5. Participates in and/or Hosts Third Party audits of T2 Biosystems.
6. Manages/administers audits of systems, processes and products to ensure compliance with regulations and company quality systems. Performs audits as needed.
7. Supports the Product Development efforts as a member of the Product Development Team. Inputs to and/or approves test development, protocols, reports, inspection instructions, inspection and/or assembly procedures, Design reviews, Design History File, etc.
8. Supports Process Development activities via inputs to and/or approvals of equipment qualifications, process validation protocols, reports, rework travelers, etc.
9. Establishes and approves methods for design and implementation of product quality test protocols, data collection systems, and final reports.
10. Responsible for the coordination of Biocompatibility, Sterility and High Level Disinfection testing and validations.
11. Supports the technical files/regulatory submission process in compliance with all ISO, IVDD and FDA regulations and requirements.
12. Assists the Management Representative for the Quality System by overseeing the development, implementation, monitoring, and improvement of quality systems.
13. Tracks audit reports and findings. Ensures that proper responses and corrective actions are implemented in a timely manner.
14. Schedules and prepares presentation materials for Management Reviews.
15. Responsible for coordination of Quality System Training.
16. Responsible for New Hire Training related to the Quality System.
17. Assures maintenance of the Organizational Chart.
18. Responsible for the maintenance of the Complaint Handling System.
19. Coordinates and/or performs materials, component and assembly inspection and/or verification as required.
20. Responsible for maintenance of the Document Control System including the safeguarding of documentation.
21. Participates in development of corrective action plans and oversees the corrective and preventative action (CAPA) program.
22. Responsible for audit of product device history record documents prior to lot release.
23. Suggests alternative methods and procedures to solve quality problems and meet quality requirements.
24. Assists in the development of company policies, operating procedures, and goals.
25. Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures.
26. Reviews and interprets test results for the Periodic Monitoring of the Controlled Environment area(s).
27. Oversees Supplier Quality System. Maintains Approved Supplier List. Delegates and/or performs vendor audits as needed
28. Oversees/manages/administers the Calibration System.
29. Confers with engineers and scientists about quality assurance of new products and/or commercially released products to prevent/rectify problems.
30. Reviews technical publications, articles, and abstracts to stay abreast of technical developments in industry.
31. Establishes operating policies and procedures that affect the quality function.
32. Manages and develops the QA staff, providing guidance based on organizational goals and company policy.
33. Coordinates prioritization of assigned projects.
34. Plans and implements QA resources to support R&D, regulatory and marketing teams.
35. Conducts briefings and technical meetings for internal and external representatives.
36. Acts as a coach to staff members on their performance or to resolve technical and/or operational problems.
37. Interprets, executes, and recommends modifications to quality system policies and procedures.

Education/Experience/Qualifications:

• Bachelors Degree from a four-year college or university.
• At least five years of your experience should be related to QA within the IVD marketplace, working with instruments as well as assays.
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Supervisory Responsibilities:

Supervises employees in the Quality Department.  Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws.  Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Knowledge/Skill/Ability Requirements:

• Knowledge of mechanical and biochemical inspection techniques and equipment
• Word processing, spreadsheets, internet software, E-mail, manufacturing software, database software.
• Ability to read, analyze, and interpret common scientific journals and reports, technical journals and financial reports. 
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 
• Ability to effectively present information to top management and public groups.
• Ability to define problems, collect data, establish facts, and draw valid statistical conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables simultaneously.

The successful candidate will be highly motivated, results driven, exceptionally talented, analytical, and a team player. If this sounds like you, please send your résumé and cover letter to careers@t2biosystems.com, and please identify the job title in the subject line.

T2 Biosystems Inc. is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, gender, pregnancy, national origin, age, military service eligibility, veteran status, sexual orientation, marital status, disability, or any other protected class.

Thoughtful Science. Tailored Solutions. NERI is a full-service Contract Research Organization that provides customized, global clinical trial solutions and registry services to pharmaceutical, biotechnology, biomaterial, and medical device companies.  NERI also has notable experience collaborating on federally-funded research with organizations like the National Institutes of Health.  Since its founding in 1986, NERI has earned widespread recognition for its scientific credibility, efficiency, and expertise in the successful conduct of clinical trials.

We currently have an opening for a full time Senior Clinical Data Manager II In that position, the Senior Clinical Data Manager II will:

• Contribute in the development of data management plans for study design and new proposals;
• Oversee data management processes required to lock study database and monitor the quality of data management deliverables.  Manage CRF processes flow and query resolution between NERI and investigational sites;
• Actively contribute to the review of working practices, training programs and data management SOP’s;
• Assist in the dissemination of results/findings and maintain communication patterns with physician, hospital staff and study sponsors;
• Act as a liaison with all study team members and other functional groups on all levels of technical requirements for database development and data quality within a study;
• Oversee data management activities and track all problems to resolution;
• Supervise data management staff to ensure that all study expectations are understood, timelines are met and communication remains open.

Qualifications:

• Bachelor’s degree in social, biological or computer science and 5 – 7+ years of data management experience or a Master’s degree in a related filed and 3 – 5+ years of significant data management experience;
• Prior experience in supervision of data management staff is required;
• Must have prior experience in clinical trials and comprehensive knowledge of GCDMP practices, FDA, ICH, GCP and 21 CFR Part 11 regulatory requirements.
• Ability to assist with the development of SOP’s, reporting systems and data management training programs;
• Excellent oral and written (including email correspondence) communication skills;
• Proven skills in a variety of data management software such as SAS, Access or Oracle and comprehensive skills in MS Office.

If interested, please visit us at http://www.neriscience.com/About/Careers/JobOpportunities/tabid/190/Default.aspx

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NERI is an Equal Opportunity/Affirmative Action Employer M/F/D/V

 Zalicus is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain, including Z160, an N-type calcium channel blocker for chronic neuropathic pain and Z944, a T-type calcium channel blocker for acute and inflammatory pain. We have entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain, inflammation, oncology and infectious disease.

We seek talented and passionate individuals who thrive in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success. Our culture reflects this ambition. Energetic and collaborative in style, we celebrate the creativity and originality of our science
 

Clinical Trials Manager

Reports To:

Vice   President, Clinical Operations

Location:

Cambridge,MA

Overview:

This pivotal role will oversee  clinical research operations  and support other clinical  activity  within Zalicus’ Trial programs. This individual will work with internal team members in driving clinical time lines, compliance and quality initiatives in addition to overseeing CRO vendors in all facets of clinical operations  

Principal   Responsibilities:

•   Assist in the development and execution of  Clinical Operating Plans
•   Assist in the development of protocols
•   Select Investigators
•   Manage Clinical trial operations, budget,  time lines, drug supply, study supplies
•   Liaise with Senior Manager, Clinical  Planning to report financials
•   Provide accurate and timely progress  reports on development, pre-  clinical,   and clinical programs
•   Assist in the assemble of clinical study  reports
•   Provide assistance in tracking  IND  safety reporting and IND  Reports
•   Assist in the review of Medical and Scientific Literature

• Facilitate and moderate Clinical meetings

• Central contact for team correspondence, communications and    documentation

• Partner with internal and external groups on activity related to clinical research(Quality Assurance, Manufacturing, Regulatory et al.)
     
    

Experience   & Qualifications:

• BA, BS or Masters Degree in Science, Nursing or related field.
• 4-5 years clinical project/program management experience a plus
• Strong multi-tasking and prioritization skills are essential for this role
• Individuals with trial experience in areas of CNS, Pain and Imaging are encouraged to apply
• Availability to travel up to 25% or more, depending on project needs, is required
• This position requires excellent knowledge of monitoring practices, demonstrated knowledge/competence in application of CFRs, GCPs, and ICH guidelines
• Excellent oral and written communication skills, attention to detail, project management skills are required for this role

 All  applicants must be eligible to work in Massachusetts  and reside in the greater Boston  area

Zalicus is a biopharmaceutical company that discovers and develops novel treatments for patients suffering from pain. Zalicus has a portfolio of proprietary clinical-stage product candidates targeting pain, including Z160, an N-type calcium channel blocker for chronic neuropathic pain and Z944, a T-type calcium channel blocker for acute and inflammatory pain. We have entered into multiple revenue-generating collaborations with large pharmaceutical companies relating to other products, product candidates and drug discovery technologies. Zalicus applies its expertise in the discovery and development of selective ion channel modulators and its combination high throughput screening capabilities to discover innovative therapeutics for itself and its collaborators in the areas of pain, inflammation, oncology and infectious disease.

We seek talented and passionate individuals who thrive in a dynamic, fast-paced, team-oriented and collaborative environment to be part of our success. Our culture reflects this ambition. Energetic and collaborative in style, we celebrate the creativity and originality of our science

Program Manager

Zalicus is seeking a Program Manager (PM) for directing its operational, planning, and decision-making processes in its development teams. This key individual will work closely with the program executive in executing (on) the overall strategic vision of the program.

Additional responsibilities include the following:

• Coordinate development process activities from a development team perspective (integrated development plans, long range plans, budget inputs and go/no go criteria)
• Facilitate the, approval and execution of global program strategy for respective programs
• Manage development team operations, i.e.
    team meetings/agendas/minutes including drive and track ‘actions’; Coordinate development team communication,

• Define and maintain the overall development budget and enterprise portfolio inputs to assist in decision making processes.
• Generate Gantt charts, spreadsheets and timeline tracking tools for project team review and updates
• Raise issues for clarification and timely resolution and act as the  point person and contact for the project team managing variances and changes for project plans.
• Ensure that approved plans are managed for optimal integration of timing, scope and resources. Manage timelines and deliverables.

Education and Experience Requirements:
• Proven experience as a project manager in pharmaceutical or biotech setting, PMP certification a plus as well as track record in budget management.

• BS/BA in an area of life science; MBA strongly preferred. A minimum of 7+ years of experience in drug a development in a biopharmaceutical environment
  • Ability to manage and lead complex cross-functional teams and processes
  • Strong knowledge and understanding of global drug product development.
  • Strong understanding and competency in planning processes and decision making

Proven experience with Microsoft Project and Visio project planning tools a must.  Experience with using Sharepoint and Microsoft Project Server would be helpful

 Skills, Abilities, and Competencies required for this role:
• Influencing without authority and interpersonal skills including  negotiation, meeting management, assessment of group dynamics and weighing  the concerns of line management with the objectives of cross-functional and executive teams.
• Strong analytical and decision-making ability, offering solution oriented proposals to complex problems
• Exceptional communication skills, both written and oral

Our client is a fast growth biologics company that is conducting a Phase III clinical trial with a product that will revolutionize treatment of cartilage injuries. Position can be located in major metro areas of California, Oregon, Arizona, or Colorado.

Reporting to the Director of Clinical Affairs, this role is responsible for day to day administration of clinical trials.

Responsibilities

• Monitor activities at clinical study site including study initiation, interim monitoring and close out visits (up to 90% travel) 
• Prepare clinical documentation (status reports, training materials, data forms, study manuals, SOPs)
• Establish and maintain strong relationships with Study Coordinators and PIs Assist with site training (GCPs, protocol, recruitment activities)
• Perform routine communications with site re: screening, enrollment, status/resolution of study queries
• Maintain clinical file, ensure clinical file documents (e.g. AEs, annual IRB reports, laboratory reference ranges, Cvs)
• Liaise with data management CRO, track status of data entry and data lock

Requirements

• BS in a health or science-related field, nursing degree preferred
• 3+ years as a clinical research monitor/associate in medical device or biologic trials
• Study start up experience
• Fluency in Windows and Microsoft Office (Word, Excel, Powerpoint)
• Strong verbal and written communication skills for interacting with internal and external stakeholders
• Able to work and problem solve both independently and as part of a team
• Able to handle multiple tasks/projects with a strong attention to detail
• Ability to travel up to 90%, with a track record of travel in the profession

Please send resume to: mdaniel@biomedicalsearch.com

Our client is seeking a Senior QA Compliance Specialist to assist in the development, implementation and management of GCP Quality initiatives.  In this position you will assure compliance with federal regulations and company standards for clinical studies as well as be responsible for coordinating and conducting both internal and external audits to assess compliance with FDA regulations.  You will assist in the development of the Quality Management System from a GCP perspective which includes writing, reviewing, and updating Standard Operating Procedures (SOPs) and associated documentation.  This position requires a BS degree in a scientific discipline with a minimum of three years industry experience in a GCP Quality Assurance / Compliance role.  Additional requirements include knowledge of Code of Federal Regulations and ICH Guidelines governing clinical research, an ability to partner internal and external partners to manage multiple projects while maintaining quality and the ability to travel up to 30%.

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

StratAcuity, CHEMISTRY IS EVERYTHING.

Our lead drug candidate, ganetespib, is moving towards Phase 3 development in non-small cell lung cancer after showing impressive overall survival improvements in Phase 2.

Director, Global Drug Safety and Pharmacovigilance

You will lead the drug safety function for Synta’s products in clinical development leading to an NDA and product launch according to FDA regulations, ICH guidelines and Company policies.  You will also be responsible for providing effective proactive safety strategies and also for the compliance for the reporting of adverse events to regulatory agencies.   

Responsibilities:

• Provide strategic drug safety/pharmacovigilance leadership and expertise
• Create/oversee operations, processes and procedures of the drug safety and pharmacovigilance functional area
• Develop, review and submit timely safety reports
• Contribute to drug safety sections of clinical and regulatory documents
• Work with safety related issues using medical and regulatory strategies to develop the best solution
• Interact with FDA safety evaluators concerning adverse event documentation
• Liason with external CRO
• Create and review SOP’s
• Create and manage US and International risk management plans 
• Develop/purchase/implement drug safety training programs

Qualifications:

• MD, PharmD, or PhD
• Minimum of 8 years relevant industry experience in drug safety and pharmacovigilance including International and management experience
• Experience with regulatory requirements and guidelines pertaining to drug safety and pharmacovigilance
• Experience with an NDA submission is preferred
• Safety regulatory writing expertise in the US and EU
• Experience in drug development procedures
• Experience working with drug safety databases
• Excellent communication skills

Synta Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, and commercializing novel pharmaceutical products for extending and enhancing the lives of patients with severe medical conditions, including cancer and chronic inflammatory disease.  For more information, please visit us at www.syntapharma.com . 

The project manager will be responsible for leading capital projects for a growing Biopharmaceutical company. The role includes managing a diverse portfolio of strategic capital projects, such as equipment and capacity upgrades, facility renovations, and infrastructure upgrades to support the development and launch of a rich pipeline of biologics products. The individual will have frequent exposure to senior management as they execute projects that shape our overall strategy and transform our site into a best-in-class Biopharmaceutical facility. Project execution will focus on safety, schedule, and budget adherence in addition to complying with good engineering practices, company policies, regulations, and codes. 1. Responsible for project management of a multimillion dollar portfolio of capital projects in a GMP environment. 2. Design and manage several facilities and process related capital projects (Biologics cell culture and purification upgrades; cryogenic storage capacity projects; HVAC and Utilities projects; laboratory and building infrastructure renovations; etc.) simultaneously to meet client's requirements. 3. Seek innovative and novel approaches for project management, design, and construction management. 4. Provide technical support to Operations supporting the implementation of new technology in the areas of biologics cell culture, protein purification, use of disposables, automation, and PAT. 5. Coordinate projects with site Maintenance, Calibration, Validation, Automation, and Facilities Departments from project initiation to closure to ensure all systems are designed, constructed, and documented properly. 6. Provide recommendations to improve and maintain facilities infrastructure.

Qualifications: B.S Degree in Engineering required. 8-10 years or more of relevant engineering and project management experience is preferred. Experience working in a biologics or pharmaceutical environment is preferred. Professional Engineering license or PMP certification is a plus.