Are you the publisher? Claim or contact us about this channel


Embed this content in your HTML

Search

Report adult content:

click to rate:

Account: (login)

More Channels


Showcase


Channel Catalog


Channel Description:

Career postings for the Massachusetts Biotechnology Council

older | 1 | .... | 777 | 778 | (Page 779) | 780 | 781 | .... | 855 | newer

    0 0
  • 10/28/15--06:52: Office & Events Assistant
  • NEHI (Network for Excellence in Health Innovation0

    OFFICE AND EVENTS ASSISTANT

    Position Description

    NEHI, headquartered in Cambridge, MA, is a national nonprofit, health policy organization that identifies and promotes innovative strategies to make health care more effective and affordable. NEHI’s policy research in medical and technology innovation, delivery system improvement, payment reform and wellness and prevention is helping to shape and inform the development of health care policy as part of the national health reform movement. With input from our members – leaders representing the full spectrum of health care stakeholders – we identify and work to remove the barriers to better health care for all patients. Check us out at www.nehi.net.

    Position Summary

    The Office and Events Assistant will primarily provide office support for NEHI and will be responsible for the coordination, planning and implementation of all NEHI events. NEHI events include board and executive committee meetings, expert roundtables, webinars, fundraisers and conferences. NEHI is committed to providing an exceptional environment in which individuals can excel and achieve their professional and personal goals. This is an outstanding opportunity for outgoing and motivated candidates to develop skills while working with senior leaders from across the health care community in a fast-paced, team-oriented environment.

    Office Support:

    • Screen and direct all incoming phone calls and greet all visitors;
    • Provide administrative support including expense allocations, correspondence, filing, faxing, copying, scanning, etc.;
    • Ensure office common spaces are tidy and presentable; order and organize company supplies; ensure printers, copiers and fax machines are functional;
    • Assist with vendor relations, including security and phone systems, building management and office IT;
    • Update administrative procedures and assist in the orientation of new staff members;
    • Provide administrative support in scheduling meetings, assist with travel arrangements and generate expense reports;
    • Provide project support to the Director of Operations; and,
    • Maintain Access and Outlook databases; enter, edit and update individual constituent and organizational information; track registrations and payments; execute queries, imports and exports of data for analysis;
    • Complete other duties as requested.

    Event Management:

    • Manage the planning and coordination of meetings and events, including 4 board meetings, annual meeting, several roundtables and one  annual fundraising dinner, all ranging from 15 – 300 attendees;
    • Assist in negotiations and review of event-related contracts;
    • Synchronize event and webcast logistics, vendor and team communication, site logistics, food and beverage orders, A/V requirements, , flowers and;
    • Work with the Director of Communications to coordinate communications aspects of events including: photography, signage, invitations and slides;
    • Lead set-up and break-down of events; preparation of name tags, invitation and registration lists, seating charts and other materials, and close out vendor payments;
      • Use the company database to coordinate registration tracking, payments to events; and,
      • Support the NEHI team in working with event speakers, including but not limited to: coordinating speaker travel, lodging, prep calls, presentation materials, event set-up and breakdown, and technology needs.
    • Coordinate preparation for mailings, meetings and special events;

    Skills and Requirements:

    • Capable of working productively on multiple projects simultaneously;
    • Demonstrated verbal, written and interpersonal communication skills;
    • Diligent individual with strong organizational skills; the ability to work in a fast-paced environment; 
    • Personable and friendly;
    • Creative and able to work independently;
    • Experienced with Outlook, Excel, Word, Access, PowerPoint and Adobe Acrobat;
    • Technology experience a plus; and,
    • Team player with a can-do attitude.

    Education/Experience:

    • Bachelor’s degree or equivalent experience preferred
    • Experience in event planning preferred

    To Apply:

    Please send a cover letter and resume to careers@nehi.net. In the subject line Include “Office and Events Assistant, Your Name.” This is a full-time salaried position beginning January 2016.

     

     


    0 0

    Who We Are

    ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells. The Company utilizes its ADC technology with its antibodies to create ImmunoGen product candidates and also out-licenses limited rights to use its technology to other companies. Roche's Kadcyla® is the first marketed product with ImmunoGen's ADC technology. More information about the Company can be found at www.immunogen.com.

    Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

    The Opportunity

    The Manager/Sr. Manager of Logistics and distribution will report to the Head of Supply Chain. He or she will oversee and manage all daily logistics activities and related systems information in a GMP manufacturing environment. The areas of responsibility include but are not limited to:

    • Facilitating the coordination of shipments and products and product availability including the efficient movement of materials (raw materials, intermediates and drug products) from place of orgin to point of delivery including third party warehousing, import/export documentation + VAT;
    • Promoting and maintaining GXP compliance throughout the logistics network as well as TSA, EH&S, and all other applicable requirements;
    • Developing, implementing, and maintaining procedures and systems for inventory control and reconciliation, logistics, distribution, receiving and transfers;
    • Assessing, recommending, and supporting the implementation of electronic ERP / inventory management system(s), as required;
    • Developing material release schedules in conjunction with quality and coordinating the efficient movement of materials with shipping or storage vendors, material planning, purchasing, production and quality and working with each group to optimize systems and procedures;
    • Developing new procedures for packaging, shipment, monitoring, etc.;
    • Working closely with cross-functional teams to ensure effective, efficient processes to support all internal and external manufacturing and testing activities;
    • Selecting, developing, mentoring and evaluating personnel to ensure the efficient operation of the function.
    • Handling exceptions, determining root causes, implementing CAPAs, and driving closure.

    Additionally, this individual will have direct responsibility for receipt, storage and distribution to Manufacturing of all components, intermediates and WIP materials for Production. This encompasses managing inventory in house as well as ImmunoGen materials maintained at Contract Manufacturing Organizations or offsite storage.

    He or she will also be responsible for overseeing / supporting all shipping including imports, exports, hazmat (DOT/IATA compliance) and clinical materials. This includes:

    • Utilizing both passive and active storage containers as well as coordination of shipments with Contract Manufacturing Organizations for Cold Chain Shipping;
    • Maintaining all storage areas in cGMP compliant and audit ready status; and,
    • Handling all QA related issues: SOPs, Deviations, Change Controls, CAPA.

    Finally, the Manager/Sr. Manager of Logistics and Distribution will be responsible for handling all US Customs and Border Protection issues such as TSA prescreening, Export and Import processes and documentation, training material handlers, classifications of materials and audit of program.

    Who You Are

    • 10-15 years of experience in the biopharmaceutical industry in Logistics/Distribution or Materials Management or related role;
    • 6-10 years in a management position;
    • Deep experience in international biopharmaceutical logistics and cold chain shipping required;
    • From and an educational perspective, a bachelor's degree in science is preferred as is APICS certification;
    • Experience with international shipping regulations, documentation, tariff / VAT structures and a broad range of couriers / freight forwarders required;
    • Prior experience in electronic management systems preferred;
    • Must be able to lift/move materials as required; and,
    • Must be able to pass TSA pre-screen and IATA / DOT certifications.

     

    ImmunoGen, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

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


    0 0
  • 10/28/15--08:09: Process Development Chemist
  • Position: Process Development Chemist (PhD)

    Job Code: 15-230
    Reports to: Senior Director, Pharmaceutical Sciences

    Location: Cerulean will be located in Cambridge, MA until December 2015, and then will be moving to Waltham, MA.

     

    ABOUT CERULEAN PHARMA INC.

    Cerulean Pharma Inc. (NASDAQ: CERU) is committed to improving treatment for people living with cancer. We apply our Dynamic Tumor Targeting Platform to create a portfolio of nanoparticle-drug conjugates, or NDCs, designed to selectively attack tumor cells, reduce toxicity by sparing the body's normal cells, and enable therapeutic combinations. Our lead product candidate, CRLX101, is in multiple clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy.  For more information, please visit www.ceruleanrx.com.

     

    POSITION OVERVIEW

    The incumbent will be a key scientific contributor within the drug substance process development function of Pharmaceutical Sciences.  Primary duties will be hands-on in the laboratory and require extensive cross-functional collaboration within Pharmaceutical Sciences, as well as with Research, Manufacturing and contract manufacturing organizations (CMOs).  Efforts will center on process chemistry R&D, including process research and optimization, scale-up, process transfer from laboratory to industrial environments, and process troubleshooting.  Further, the position requires a high level of technical independence, success-oriented behavior and can-do attitude in an entrepreneurial environment. 

     

    PRINCIPAL RESPONSIBILITIES

    • Laboratory-based process development chemist, with hands-on responsibility for process chemistry R&D activities, incl. supportive routine analytics
    • Interaction with medicinal chemists and review of research synthetic schemes to support laboratory transition of new IND candidates into early development
    • Hands-on contributor to improvement, optimization, and scale-up of chemical syntheses/processes for new and existing DCs
    • Process industrialization: support transfer of in-house synthetic schemes into production (GLP tox and cGMP clinical supplies), in collaboration with Manufacturing
    • Collaboratively support strategy development and chemical process evolution through clinical development and product registration
    • Problem solving: hypothesis formation, experimental design and conduct, data evaluation and interpretation
    • Collaborate with CMC scientists, CMO/CRO partners, and project management to support all technical needs of assigned projects
    • Hands-on, in-house laboratory troubleshooting of manufacturing non-conformances
    • As-required support of Manufacturing, incl. batch record review and investigations
    • Play active hands-on role in department laboratory build-out initiative
    • Participation in drug substance specification development
    • Authorship of drug substance sections in regulatory submissions
    • Technical report writing
    • Regular participation on CMC sub-teams and as-required department representation on project teams

     

    QUALIFICATIONS

    • PhD in organic chemistry with 2-5 years of hands-on chemical process R&D experience in pharma and/or biotech
    • Combination of working knowledge, experience and understanding of the following:
      • Synthetic chemistry
      • Polymer chemistry (preferred)
      • Process development, transfer and scale up
      • NMR, mass spectroscopy, chromatography, and other core analytics
      • Current Good Manufacturing Practices (cGMP)
      • Proficiency with basic process chemistry R&D workflows, including recent relevant laboratory experience
      • Ability to manage and prioritize work for multiple concurrent projects
      • Ability to independently and collaboratively design experiments, followed by implementation in the laboratory
      • Excellent verbal communication and writing skills

     

    To be considered for the position, please submit your resume to careers@ceruleanrx.com and reference the job code 15-230.


    0 0

    Position: Medical Monitor & PV Director (MD)

    Job Code: 15-140

    Reports to: Chief Medical Officer

    Location: Cerulean will be located in Cambridge, MA until December 2015, and then will be moving to Waltham, MA.

     

    ABOUT CERULEAN PHARMA INC.

    Cerulean Pharma Inc. (NASDAQ: CERU) is committed to improving treatment for people living with cancer. We apply our Dynamic Tumor Targeting Platform to create a portfolio of Nanoparticle Drug Conjugates designed to selectively attack tumor cells, reduce toxicity by sparing the body's normal cells, and enable therapeutic combinations. Our first platform-generated candidate, CRLX101, is in multiple clinical trials in combination with other cancer treatments, all of which aim to unlock the power of combination therapy. The U.S. FDA recently granted CRLX101 Orphan Drug designation for the treatment of ovarian cancer and Fast Track designation in combination with Avastin in metastatic renal cell carcinoma. Our second platform-generated candidate, CRLX301, is in a Phase 1/2a clinical trial. For more information, please visit www.ceruleanrx.com.

     

    POSITION OVERVIEW

    The successful candidate will be responsible for providing Clinical Monitoring and Clinical Pharmacovigilance for early and late stage clinical development programs in accordance with the appropriate regulatory guidelines. Set up tracking systems and work with clinical, regulatory, and contract research organizations (CROs) to ensure that all clinical safety pharmacovigilance is performed across all ongoing clinical trials with minimal supervision. 

    Primary Responsibilities:  

    • Monitor clinical trials
    • Organize and oversee the receipt, evaluation, processing, documentation, and reporting of serious adverse event information from clinical trials, investigator trials and post-marketing sources
    • Reviewing and approving adverse events reports from clinical sources in accordance with WHO-ICH guidelines and the appropriate regulatory agencies, including FDA.
    • Develop and implement SOPs and other controlled documents to support investigational and marketed product safety surveillance
    • Manage and conduct ongoing safety surveillance and oversee the evolving safety profiles for all company products; identify and analyze safety signals
    • Perform aggregate analyses of specific events across studies
    • Monitor CRO performance to ensure optimal safety assessment and reporting of ongoing clinical trials
    • Prepare new drug application safety updates, investigational new drug safety reports, investigator communications, Periodic Safety Update Reports (PSURs) and other reports as necessary
    • Prepare and/or edit patient narratives for SAE safety reports and perform analyses of like events
    • Participate on cross-functional product/project teams including review of safety section of protocols, investigator brochures, informed consent forms, marketing documents and other documents providing safety content
    • Develop and implement Pharmacovigilance training programs for both internal and external use
    • Set up and utilize appropriate databases, tracking tools
    • Liaise with Clinical Operations, Regulatory Affairs and Quality to ensure appropriate and timely communication/dissemination of safety information to internal members and external stakeholders
    • Prepare for regulatory inspections and audits 

    QUALIFICATIONS

    • MD with previous significant experience in monitoring clinical activities
    • Previous management or project management experience
    • Preferred minimum of 5 years total experience in US and/or international pharmacovigilance/drug safety, or equivalent relevant clinical development experience in Pharmaceutical and/or Biotechnology industry
    • Must have demonstrated working knowledge of domestic and international regulatory safety reporting requirements, including FDA/ICH guidance’s related to pharmacovigilance and Good Clinical Practices, as well as working knowledge of Code of Federal Regulations regarding drug safety
    • Has the capacity to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
    • Must have excellent, concise writing skills, including excellent communication, interpersonal skills and experience in working in multidisciplinary teams
    • Has the ability to work independently with minimal supervision, multi-task with attention to detail, is able to manage multiple projects under tight deadlines, independently identify problems and effectively offer solutions

    To be considered for the position, please submit your resume to careers@ceruleanrx.com and reference the job code 15-140.


    0 0
  • 10/28/15--08:19: CLIA Site Director
  • Company Overview:

    Berg is a Greater Boston based company that employs a novel approach to systems biology and utilizes systems engineering and bioinformatics modules to cross-validate biological output. The Berg Interrogative Biology™ Drug Discovery Platform allows for rapid and precise identification of therapeutic and biomarker candidates for drug discovery and development. The company uses network biology to mine disease pathophysiology.

    Job Description:

    Reporting directly to the Head of Diagnostics, the CLIA Site Director will be a scientific lead to the CLIA laboratory, manage and maintain CLIA standards within the laboratory, and be responsible to all operations within this regulated lab.

    Responsibilities:

    • Direct the CLIA group at Berg Diagnostics in Biomarker and Protein Therapeutics quantitative assays and lead the effort in immunoassay and LC/MS assay development and validation.
    • Provide overall operation and administration of the laboratory, including the oversight of personnel and budget.
    • Oversee CLIA state inspection and maintain the CLIA laboratory license.
    • Ensure testing systems developed and used for each of the tests in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic and post analytic phases of testing.
    • Ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed and provide a safe environment in which employees are protected from physical, chemical and biological hazards.
    • Ensure that test methodologies selected have the capability of provided the quality of results required for patient care.
    • Verify that procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method.
    • Ensure that laboratory personnel are performing the test methods as required for accurate and reliable results.
    • Ensure that results are returned within the timeframes established by the proficiency testing program.
    • Ensure that the quality control and quality assessment program are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur.
    • Liaise with external sites to drive prospective trials.

    Qualifications:

    • Requires a PhD in physical, chemical, biological or clinical laboratory science from an accredited institution.
    • Must hold a current board approved certification by HHS such as:
      • ABB – American Board of Bioanalysis 
      • ABB public health microbiology certification
      • ABCC – American Board of Clinical Chemistry
      • ABCC 24-month Commission on Accreditation in Clinical Chemistry (COMACC)
      • ABFT – American Board of Forensic Toxicology
      • ABHI – American Board of Histocompatibility and Immunogenetics
      • ABMG – American Board of Medical Genetics
      • ABMLI – American Board of Medical Laboratory Immunology
      • ABMM – American Board of Medical Microbiology
      • NRCC – National Registry of Certified Chemists

    OR

    • MD from an accredited institution and be certified in Clinical Pathology by the American Board of Pathology
    • Must possess the appropriate current license issued by the State of MA and 1-3 years of experience as a CLIA Site Director.
    • Sufficient experience in leading immunoassay and LC/MS assay development and validation.
    • Be familiar with GLP practices and compliance.

    Contact:


    0 0
  • 10/28/15--08:26: Head of IT
  • Reporting directly to the CFO, the Senior Director of IT will have an opportunity to build the IT function in a dynamic, growth-oriented public company with an opportunity to become a first-in-field leader in an exciting new therapeutic space.  You will be the primary IT advisor to the Company, an active part of building all aspects of our IT strategy and infrastructure from the ground up.   You will start with the basics of WiFi connectivity, phone network reliability, and data security.   As we grow, you will help us move into the cloud, build ERP systems with complex manufacturing and supply chain requirements, manage multiple site locations, and identify new tools to help with productivity and organizational efficiency.    Some key areas of influence include:

     

    • Systems & Networks -  Lead & manage onsite, mobile and cloud based company infrastructure, make decisions on in-sourced vs. outsourced deskside support as well as telecommunication activities; provide multi-platform support to meet the various needs of different user groups, determine strategy for data center and back-up locations, and probably a whole list of other things we haven’t considered yet.

    • Data Integrity/Security - Working closely with Legal, you will ensure we have the appropriate protections in place to maintain our  data integrity and confidentiality as we carve out our footprint as leaders in the microbiome sciences.  You will help us strike the right balance between supporting collaboration tools (Macs, Google platform) versus increasing requests from regulatory-minded individuals for PCs with Microsoft Office/Sharepoint.

    • Business Applications - Lead portfolio and resource management capabilities, driving the prioritization of technology projects.  Work with business technology architects to identify potential solutions that match the business strategy with the technology strategy.  Drive all budget and cost decisions.

    • Compliance - You will advise on matters of IT compliance.  You will also help define and promote those behaviors which will help establish good corporate practice in IT at Seres.

     

    You will be a good fit for this role if you have significant industry experience in both small/biotech and large/pharmaceutical or biologics companies, preferably in a previous Head of IT role.   You will also have led a company through significant transitions via facility expansion and/or move and product launch.   In other words, you woke up one day and suddenly discovered that you had several hundred brand new end-users to support.  Most importantly, you will be willing to roll up your sleeves and do “real work.”   You will strive to be a good partner and put your own interests behind those of the team.   We work at a rapid pace and we are navigating an entirely new scientific area with unique challenges.    We also have a near term commercial opportunity with our recently attained “Breakthrough” designation for our lead asset, SER 109. If this sounds interesting, we’d love to hear from you.   

     


    0 0
  • 10/28/15--09:07: Research Associate
  • Ra Pharmaceuticals is a development stage Biotechnology Company with a platform that enables the discovery of novel therapeutics.  Ra Pharma combines novel insights into complement and other innate immunity pathways with leadership in macrocycle technology to transform the lives of patients with life threatening disorders. Our primary clinical focus is on diseases of complement dysregulation and orphan indications defined by validated biomarkers.

    Description We are currently seeking a research chemist to join our chemistry group and contribute to the synthesis, purification and characterization of small molecules using state-of-the-art methods.

    Qualifications:

    The ideal candidate will have a M. Sc. in Chemistry, with at least 4 years of synthetic organic chemistry based lab experience. The ability to work independently with a focus on synthesis, characterization and purification of small molecules is required. Candidates must be capable of designing, planning and troubleshooting multi-step, organic synthesis routes, be proficient in identifying structure activity relationships (SAR) to improve lead profiles based on: potency, selectivity, and pharmacokinetics and demonstrate excellent communication skills, flexibility and initiative, and must have the ability to work effectively as part of a multidisciplinary team of chemists and biologists.

     


    0 0

    Company Description

     

    Curis is a biotechnology company seeking to develop and commercialize innovative drug candidates for the treatment of human cancers. Our most advanced drug candidate is CUDC-907, an oral, small molecule inhibitor of histone deacetylase (HDAC), and phosphatidylinositol-3-kinase (PI3K) enzymes, which has completed the dose escalation stage of a Phase 1 clinical study. Curis is also engaged in a broad collaboration with Aurigene in the areas of immune-oncology and precision oncology. As part of this collaboration, we expect to exercise options to exclusively license small molecule antagonists of programmed death ligand-1 (PD-L1) and interleukin-1 receptor association kinase-4 (IRAK4) and file IND applications for both molecules.

     

    Our most advanced program, a Hedgehog pathway inhibitor program developed in collaboration with Genentech (Roche), led to the commercialization of Erivedge® (vismodegib), the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma.  Genentech/Roche are responsible for the development and worldwide commercialization of Erivedge. Roche and Genentech are also continuing Erivedge®’s clinical development in less severe forms of BCC as well as planned development in other non-oncology indications.

    Our corporate culture is focused on learning and growing in a challenging environment with a committed group of peers working together as a team. For more information, visit Curis' website at www.curis.com.

    Research Associate – Cancer Immunology

     

    Curis is expanding its team and has an exciting opportunity for a Research Associate, Cancer Immunology. This person will support the functional characterization of small molecule compounds in the context of preclinical and translational immune-oncology programs. (S)he will support the development of in vitro and ex vivo immunological assays to isolate and evaluate the function of tumor infiltrating immune cells. (S)he will conduct hands-on laboratory work to isolate immune cells from tissue samples, including tumor and blood, and to evaluate T cell function in vitro.

     

    The ideal candidate will have:

     

    • Experience in the isolation/purification of primary immune cell types from tissues of human or mouse origin (required).
    • Working knowledge of the in vitro culture and functional analysis of mouse or human T-cells (required).
    • Experience with single and multiplexed methods of cytokine detection and quantification (i.e. ELISA, MSD, qPCR) (required).
    • Hands-on experience with flow cytometry is highly preferred.
    • A working knowledge of tumor-relevant immune cell types (T cells, MDSCs, etc.) is highly preferred.
    • A basic knowledge of animal models of tumor immunology or autoimmunity/inflammation is preferred.

     

    Additional Qualifications:

    • B.S./ M.S. degree in Immunology/ Molecular Biology/ Biology with at least 2 years of experience in cellular immunology or an immuno-oncology laboratory in an academic or biopharmaceutical setting.
    • The ideal candidate is a self-motivated, detail-oriented, team player who is comfortable in a fast paced, dynamic and rigorous research environment.
    • Excellent oral and written communication skills are required.

     

    Please send CV with job code (RACI200) to:

    Human Resources,
    Curis, Inc.
    4 Maguire Rd.
    Lexington, MA 02421

    Email: jobs@curis.com or Fax: 617.503.6501.

    No phone calls please.

    Curis, Inc. is an Equal Opportunity Employer.


    0 0

    Research Associate, Bioprocess

     

    Symbiota is developing microbiome-based agricultural solutions to improve crop yields with sustainable products derived from plant microbiomes.  The Research Associate will implement qualitative and quantitative assessment, production and storage of Symbiota’s proprietary microbes.

    Outcomes

    1. Cultivate microorganisms for deployment into field-trials, including
    • Media and flask preparation and quality control
    • Production of seed inoculum
    • Shake-flask and fed-batch, bioreactor fermentation
    • Biomass recovery via filtration and centrifugation
    • Drying of biomass
    • Grinding and formulation of biomass
    • Microbiological quality control

         2.  Characterize the physiology of bacterial and fungal strains
         3.  Culture monitoring (pH, biomass concentration, and other parameters vs. time)
         4.  Implement analytical/molecular assays to monitor microbial growth

    Competencies

    • Bachelor’s or Master’s degree in chemical or biochemical engineering with strong microbiology background and >2yrs of industry experience with microbial fermentation or mammalian cell culture.
    • Experience with bench top fermenters is preferred
    • Proficiency performing aseptic techniques, microbial cultivation, molecular techniques including nucleic acid extraction, and PCR.
    • Desirable experience in a biotech setting.
    • Organized, methodical, and meticulous.
    • Flexibility/adaptability. Adjusts quickly to changing priorities and conditions.  Copes effectively with complexity and change.  Comfortable with ambiguity.
    • Efficient.  Able to produce significant output with minimal wasted effort.
    • Attention to detail.  Does not let important details slip through the cracks.
    • Proactive. Acts without being told what to do.  Brings new ideas to the company.
    • Work Ethic.  Possesses a strong willingness to work hard and sometimes long hours to get the job done setting an example for the team.  Has a track record of delivering on ambitious goals.
    • Communication.  Speaks and writes clearly and articulately.
    • Enthusiastic.  Bought into the larger mission of Symbiota and excited about the possibilities.

     Location

     

     

     


    0 0
  • 10/28/15--09:28: Bioprocess Engineer
  • Process Engineer, Bioprocess

     

    Symbiota is developing microbiome-based agricultural solutions to improve crop yields with sustainable products derived from plant microbiomes.  The Scientist will report to the Head of Bioprocessing and will lead efforts on the process development and scale-up to support the production of Symbiota’s proprietary microbes.

    Outcomes

    • Develop scalable fermentation processes for Symbiota’s proprietary microbes that meet projected cost of goods sold.
    • Identify and evaluate contract manufacturing facilities to support various production scales.
    • Draft documentation for transfer of process technology to contract manufacturing facilities.
    • Oversee and manage production campaigns at contract manufacturing facilities as needed.
    • Participate in the production of microbes for field and greenhouse testing.

    Competencies

    • M.S. in (bio)chemical engineering and >2yr of industry experience, or B.S. in (bio)chemical engineering and >4yr of industry experience.
    • Prior experience with design and operation of microbial fermentation or mammalian cell bioreactor equipment for process development is required.
    • Prior experience with the scale-up of fermentation and harvesting processes at a contract manufacturing organization is ideal.
    • Proficiency performing aseptic techniques, microbial cultivation, molecular techniques including nucleic acid extraction, and PCR.
    • Effective communication with outside parties, suppliers, and consultants.
    • Attention to detail and ability to multitask and to meet deadlines, sometimes under ambiguity.

    Location


    0 0
  • 10/28/15--09:31: Scientist - Bioprocess
  • Scientist, Bioprocess

     

    Symbiota is developing microbiome-based agricultural solutions to improve crop yields with sustainable products derived from plant microbiomes.  The Scientist will report to the Head of Bioprocessing and will lead efforts on the process development and scale-up to support the production of Symbiota’s proprietary microbes.

    Outcomes

    • Develop scalable fermentation processes for Symbiota’s proprietary microbes that meet projected cost of goods sold.
    • Identify and evaluate contract manufacturing facilities to support various production scales.
    • Draft documentation for transfer of process technology to contract manufacturing facilities.
    • Oversee and manage production campaigns at contract manufacturing facilities as needed.
    • Participate in the production of microbes for field and greenhouse testing.

    Competencies

    • Ph.D. in (bio)chemical engineering and >2yr of industry experience, or M.S. in (bio)chemical engineering and >6yr of industry experience
    • Prior experience with design and operation of microbial fermentation or mammalian cell bioreactor equipment for process development is required.
    • Prior experience with the scale-up of fermentation and harvesting processes at a contract manufacturing organization is ideal.
    • Proficiency performing aseptic techniques, microbial cultivation, molecular techniques including nucleic acid extraction, and PCR.
    • Effective communication with outside parties, suppliers, and consultants.
    • Attention to detail and ability to multitask and to meet deadlines, sometimes under ambiguity.

    Location


    0 0

    Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine is developing clinical laboratory tests that will broadly capture the most relevant tumor genomic and other molecular information in a single test, and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient.


    Foundation Medicine is seeking a Corporate & Business Development Specialist. The Specialist will play an integral role in the financial planning, modeling and forecasting process for the biopharma business unit for the Corporate and Business Development. The Corporate & Business Development Specialist will function as the primary liaison between external partners, internal support groups and will be responsible for providing, planning and analytics in support of the stakeholders involved with the biopharma business .

    Assist in the strategic planning and analysis processes, including the development of annual operating plans, revenue models, business plans, etc. Manage a monthly financial forecast process that provides the organization with a current best estimate of future financial performance.

    • Assist in monthly and quarterly business review processes and lead development of annual operating plan
    • Develop in-depth knowledge of the team’s contracts and business relationships
    • Develop, build and maintain business reporting and planning models
    • Other analytical projects as necessary

     

    Required Skills and Experience

    • Mix of private and/or public company experience
    • Must have strong computer, analytical, and mathematical skills. High-level proficiency with MS Excel is essential
    • Knowledge of financial and accounting principles
    • High-caliber professional with written and verbal communication and interpersonal skills. Ability to participate in and facilitate group meetings and work with cross functional teams
    • Work requires willingness to keep a flexible schedule as projects dictate and adapt quickly to changing priorities in a fast-paced environment
    • Good organizational skills and strong attention to detail
    Education and Required Experience
    • Bachelor's degree in business, finance, engineering, or other quantitative discipline. A minimum of 2 to 5 years of consulting or other relevant work experience.
    • Completion of a corporate leadership development program is highly desirable
    • Experience in the pharmaceutical or biotechnology industry is highly desirable



    Apply Here

    PI92191661


    0 0
  • 10/27/15--22:06: Senior Account Executive
  • WE Worldwide’s Healthcare Sector continues its expansion and track record of impressive year over year growth. With a 360 degree perspective on the healthcare industry, we provide a breadth of communications services to clients across sectors including medical devices, pharmaceuticals, biopharma, healthcare IT and consumer health products. We develop innovative programs that reach and influence physicians, advocates, patients, regulators, policy makers, payors and the public at large.

     

    Currently, we have an opening for a senior account executive to join our team in Boston. We are looking for a self-starter who is brimming with creative ideas, energy, and a passion for healthcare and for learning new skills. This is a terrific opportunity for a team player who wants to hone his or her integrated communications, business and management skills. If you are forward-thinking, well-informed, thoughtful and results-oriented then we’d like to hear from you.

     

    Responsibilities

    • Oversee and execute earned and social media programs for clients
    • Develop and create meaningful content that reflects a client’s voice and market
    • Build strong relationships with clients and team
    • Mentor other staff to expand their skills and knowledge
    • Demonstrate a deep understand of client’s business and where it fits in the larger healthcare industry context
    • Have a confident presence with clients and the ability to provide insights and counsel about communications strategy and opportunities
    • Have existing relationships with members of the healthcare media and demonstrate a knowledge of the media landscape
    • Excellent written communication including all types of materials from press releases to emails
    • Attention to detail to ensure excellent work product every time

    Qualifications

    • Bachelor’s degree or above preferred in Communications, Journalism, Marketing, English or related field
    • At least 3 years of experience in integrated communications required, preferably in an agency setting and/or within the healthcare industry.
    • Has established media relationships and has proactively placed stories
    • Demonstrated ability to establish strong client relationships

    0 0

    Talent Team / Human Resources Business Partner - Discovery

    Are you looking to help people get better at their jobs, and become more motivated every day? Merrimack Pharmaceuticals is a mission-driven organization that is passionate about curing cancer.  We recently commercialized a drug with proven benefit to patients with pancreatic cancer. In the Discovery Business Unit of Merrimack, where ideas for a novel cancer therapeutics and companion diagnostics are generated, developed, and taken into the clinic, we are looking for a Talent/HR Business Partner to lead the Talent Strategy. This role offers a blend of progressive talent management and more traditional HR generalist responsibilities. As an integral member of the Discovery team, you will contribute most of your time to programs and initiatives in this Business Unit, with additional involvement in company-wide activities in close partnership with your Corporate Talent Team (HR) Teammates.  Sound good?   Then keep reading …

    Job Responsibilities

    Talent Management: You’re someone who knows that the best results comes from high performing teams who fully leverage the talents of each person and work cohesively towards achieving objectives. You have some experience leading team alignment processes and helping teams to develop new capabilities and ways of working together. Additionally, you are comfortable providing 1:1 coaching to leaders, managers, and employees on issues affecting individual, team, and organizational performance.  Ideally, you also have some employee relations experience and can independently investigate and resolve matters. If you do not have this experience you are eager to learn the tools of the trade so that you are able to address issues when they occasionally arise at Merrimack.

    Human Resources: You enjoy supporting the full breadth of strategic HR programs and services. You are adept at analyzing and presenting employee data and trends in order to provide the business with timely information about its organizational structure, employee attrition and retention, compensation, and much more. HR nuts and bolts activities such as onboarding, employee engagement surveys, career paths, reward and recognition programs, are all areas you enjoy innovating and executing. Ideally, compensation management and HR Analytics are also competencies of yours. If not, you are eager to develop these skill sets!

    Working In a Team-Based Organization:  You consistently work in a manner that demonstrates values of teamwork, continuous learning, authenticity, and passion for improving organizational performance. There can be no doubt that you enjoy being part of a dynamic team and working with others to reach the best solutions. People view you as someone with excellent judgment and competence with issue analysis and resolution. You quickly translate complex problems into simple and actionable solutions.  You build strong relationships and inspire trust and confidence with a wide variety of people at all levels of the organization.

    Requirements:
      You have at least a Bachelor’s degree (Masters preferred) and 8 or more years of Talent Management experience. Ideally you’ve worked in biotech or life sciences, with highly technical employees. You care deeply about Merrimack’s mission to cure cancer.  You’re the consummate team player, who can work effectively in a highly-integrated team. You know how to manage junior staff. And you work best in environments where everyone rolls up their sleeves and does whatever it takes to get the job done.

    What do you think?  Ready to apply?  We’d love to hear from you! 

     


    0 0
  • 10/28/15--00:00: Senior Research Officer
  • Title: Senior Research Officer, Boston Ma

    Description of Company:  Our client seeks a talented and enthusiastic individual to join their growing community as a Senior Research Officer (SRO). As a manager of sponsored and research projects, this individual will administer pre- and post-award aspects of a complex portfolio for interdisciplinary faculty whose funding sources range from NSF, DoD, DOE, NIH, ONR, DARPA and other federal and private sources. She/he will work directly with a senior faculty member and his lab to created and submit proposals, create budgets, authorize and approve expenditures, review of monthly, quarterly and annual financial reports, forecast financial scenarios, and make sound recommendations for spending plans. The SRO may also be expected to participate in sponsor update and kickoff meetings, to present financial data to sponsors and to function as a member of a given project team when required.

    Description of position:  The Senior Research Officer will work independently in a large research lab environment, but will work closely with the Genetics Business Office and be expected to participate in special projects to support the Business Office and Department. S/he will provide an outstanding level of customer service to a broad customer base on a wide range of very complex pre- and post-award, sponsored and compliance issues. She/he will provide a management-level liaison with other university offices, the financial offices of relevant departments as well as other universities connected to the lab's research programs, and with industrial biotech interests. She/he will work closely with collaborators on funding opportunities and joint ventures.

    Position Responsibilities

    • Identifying  and disseminating funding opportunities, proposal and budget creation and  development, application submission
    • Liaising  with the University Sponsored Research Administration, the Office of  Sponsored Programs, the Office of Technology Development on industry sponsored research agreements, as well as collaborators at other academic  and start-up institutions
    • Overseeing and managing funds and communicating with the lab
    • Working closely with the lab and department on the monthly expenditure reconciliation, interpreting and applying financial and compliance-related policies
    • Ongoing monitoring of special terms and conditions
    • Preparing financial updates for Principal Investigator, sponsors, the department and  company’s offices
    •  Preparation of agreements, and drafting  of other research related documents (billing agreements, etc.)
    • Update personnel funding and will work the PI to determine funding
    • Will work with the PI on all effort certifications
    • Will use a high degree of judgment and problem solving skills to communicate and apply company’s sponsor guidelines throughout the sponsored project life cycle
    • Working closely with other university departments staff, post-docs, and students, as well as other company’s departments and administration offices
    • Requiring excellent written and verbal communication skills

    Candidate Requirements:

    • Bachelor's degree in Business, Finance or related field required
    • 5-7 years of experience in sponsored research administration or related experience required
    • MBA preferred
    • Working knowledge of the federal circulars (2 CFR 200), FAR; NIH policies and procedures; NSF policies, procedures and FASTLANE
    • Familiar with current issues in sponsored research administration
    • Familiarity with federal and procurement-type contracts is a plus
    • Self-directed, can prioritize duties and meet multiple deadlines
    • Need to be able to use a high degree of judgment
    • Need to be able to make sound independent decisions
    • Attention to detail and ability to multitask is required
    • Strong written and verbal communication skills
    • Need to be able to work independently with minimal supervision
    • Handle complex and confidential information with discretion
    • Strong computer and/or analytical skills
    • Desire and aptitude to learn complex data query tools required
    • Customer service focus required

    0 0
  • 10/28/15--00:05: Technology Licensing Officer
  • The Massachusetts Institute of Technology invites applications for a Technology Licensing Officer – Biotechnology.  The Technology Licensing Office seeks an individual to manage an intellectual property portfolio of inventions in the field of biotechnology.  This individual will license inventions arising from research at M.I.T.  Responsibilities will include assessing commercial potential, managing the patenting process, identifying potential licensees, marketing inventions, and negotiating license agreements to established companies and new startups.  Additional responsibilities include negotiating intellectual property terms of university-industry collaborations.  Interested candidates should apply on-line at http://careers.mit.edu/.   Please reference job number 12826 and indicate where you saw this posting.  MIT is an equal opportunity/affirmative action employer.  Applications from women, minorities, veterans, older workers, and individuals with disabilities are strongly encouraged.   MIT is unable to consider candidates for this position who require employer sponsorship for employment-based visas or for exchange visitor visasPlease also note that M.I.T. does not reimburse candidates for costs associated with interviewing or relocation.  If you reside outside the greater Boston area, but plan to visit soon and would like to apply for this position, please indicate the dates that you would be available for interviewing in the cover letter forwarded with your application.  

     

    Qualifications:    A minimum of a B.S. in biology or biological engineering with some research experience.  Advanced degree preferred.  A minimum of seven years’ experience in industry in a non-bench position involving marketing, product management or business development is an absolute requirement.  Knowledge of the biotechnology, medical device and/or pharmaceutical industry required.  Must be able to interact with a wide range of people including faculty, students, industrial managers, lawyers, and venture capitalists.  Truly exceptional oral and written communication skills are essential, as is a talent for negotiation.  The ability to diagnose complex business,  interpersonal, and inter-organizational issues and deal with ambiguity is required.  Seeking a highly motivated self-starter who can juggle many assignments at once.  

     


    0 0

    ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

    Summary:
    The Quality Systems Associate Director/Director will lead the effective administration of ARIAD’S harmonization and continuous improvement activities to the Quality Management System Policies and Procedures. Responsibilities also include oversight of the Quality Information Systems department that serves as Business Owner and Process Owner of quality document control/training, change control, non-conformance, and CAPA. This position is also responsible for leading the development and maintenance of quality system management review mechanisms in terms of product quality and conformance to regulations and ARIAD quality policies. The Quality Systems Director shall operate to meet the requirements of International standards and regulations in compliance with ARIAD’s Quality Management System. He / She will report to the Senior Director of Regulatory and Quality Systems as part of the corporate QA function and will work closely with the ARIAD organization to ensure all Quality Systems are effectively designed, implemented, and compliant with GxP.

     

    Duties and Responsibilities: 

    • Collaborates cross-functionally to develop, establish, monitor, and continuously improve GxP policies, procedures, and practices ensuring performance and quality conforms to established company, international (ISO), and governmental regulatory standards and agency guidelines in regards to the Corporate Quality Systems.
    • Identify and manage continuous improvement projects through staff with expertise in quality information systems, business excellence, and business systems with the objective of achieving quality, reliability, productivity, and cost improvements.
    • Serve as Process Owner and Business Owner of the Quality Information Management System, including non-conformance, CAPA, change managements, document control, and SOP training.
    • Direct the Quality Information Systems organization through strong leadership presence, mentor staff by providing continuous education on GxP and Quality System regulations.
    • Drive a Quality culture of team-work and partnering not only within the Quality organization, but also with quality operations, QC, regulatory, manufacturing and other key groups across the company.
    • Represent Quality Information Systems on the Global Change Review Board and other assigned Quality boards.
    • Lead the preparation of periodic reports, including Annual Product Reviews, for Management on the overall health of the ARIAD Quality System and any pertinent information that is needed for their attention/action.
    • Investigate and address issues related to the Quality Management System as applicable through the appropriate CAPA process.
    • Perform as a Subject Matter Expert for the Quality Management System processes and systems and provide support during internal and external audits.
    • Develop methods to monitor, track, and report on status of compliance gap assessments.

     

    Experience: 

    • +8/+10 year’s relevant Quality experience in drug and/or biologics within the biotech/pharmaceutical industry in late stage development/ commercial manufacturing
    • Excellent writing skills is a must
    • Experience in writing Policy and Procedure for Quality Management Systems is a must
    • The ability to thrive in and have effect on a fast-paced evolving culture is highly recommended
    • PMP or Six Sigma certification preferred
    • Required Bachelor's Degree Required

     

    Personal Characteristics: 

    • Inspire and Motivate Others.
    • Able to lead key initiatives; mentor and motivate teams to work collaboratively to achieve objectives. Maintains focus on key priorities. Provides clear direction, delegates, actively communicates.
    • Transformation Leader. Able to align diverse functional areas through appropriate socialization to affect change towards a highly functioning Quality culture.
    • Possesses unquestioned integrity and strong business ethics. Has an excellent reputation; able to establish trust.
    • Informed Risk Taking. Able to assemble and analyze relevant data for risk assessment and mitigation.. Capable of thinking out of the box and taking measured risks.
    • Communicate Effectively. Ability to convey complex concepts and strategies, orally and in writing. Effectively manages meetings. Strong presentation skills. Excellent listener; seeks broad input and feedback; frequent and effective follow-up.



    Submitting a resume online at a job site could cause valuable screening information to be missed.

    Click here to apply:
    http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=592&company_id=16419&jobboardid=306

    ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.


    0 0

    General Scope and Summary

    SAGE Therapeutics is searching for a creative, resourceful, integrative thinker and leader for a highly-visible role in the Nonclinical Development Department. The successful candidate will be responsible for designing and overseeing nonclinical safety testing programs for assigned clinical candidates.  They will also be a program leader leading a multi-disciplinary team to advance select compounds from development nomination through to first in human trials. The successful candidate will also help in the development of annual budgets and making strategic departmental decisions. This position regularly interacts in an independent manner with all levels and disciplines of the organization including Discovery Research, Clinical, Regulatory, CMC, Technical Operations, and Quality Assurance.

    Specific Roles and Responsibilities Include:

    • Independently lead a multi-disciplinary program team to advance select compounds from development nomination through to IND/CTA filing and initiation of Phase 1 clinical trials.
    • Collaborate with Discovery Research in the screening and selection of candidate compounds for progression into development
    • Design safety testing programs (including safety pharmacology and toxicology testing) for assigned IND/CTA and clinical stage candidates
    • Contract research laboratory (CRO) selection/study director interactions/monitoring, study result interpretation, and report finalization
    • Serve as lead Nonclinical representative on select program teams/subteams
    • Prepare all relevant nonclinical regulatory documents including written and tabulated study summaries in Common Technical Document (CTD) format, Annual Reports, Investigator Brochures, integrated summaries for regulatory submissions, and respond to queries from Regulatory Authorities
    • Determine qualified levels of impurities to set drug substance/drug product specifications at all stages of clinical development
    • Participate in regulatory meetings/interactions. Prepare nonclinical CTD summaries for NDA/MAA filings and respond to queries from Regulatory Agencies

     Experience, Education and Specialized Knowledge and Skills

    • Ph.D. with 8+ years as a toxicologist within the pharmaceutical industry; DABT certification and experience in safety pharmacology and pharmacokinetics preferred
    • Experience in drafting nonclinical written and tabulated CTD sections for worldwide regulatory submissions
    • Working knowledge of GLP requirements and worldwide guidelines for nonclinical safety testing
    • Strong leadership skills; ability to independently lead a multi-disciplinary team
    • Strong analytical, leadership, as well as written and verbal communication skills
    • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
    • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
    • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes
    • Strong team player that has a customer service approach and is solution oriented
    • Attention to detail and the ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun
    • Travel will be required and is anticipated at a maximum of 20%

     


    0 0

    Under the direction of the Director of Regulatory Affairs, direct and manage Regulatory Affairs activities for developing global CMC strategies across product life cycles & execution in North America. Provide collaborative support for execution of global strategies to other regions (EU & International). Manage submissions and interactions with the FDA and Health Canada for CMC issues. Provide support to other HA interactions as required.
    Provide regulatory support, guidance and expertise to internal groups such as product development, QA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned.
    Manage preparation of US and Canada applications in a timely manner to meet corporate objectives.
    Collaborate with EU & International regulatory colleagues to ensure global perspective and provide support in the preparation of EU and International regulatory documentation in a timely manner to meet corporate objectives.
    % of Time Job Duty and Description
    30 Develop global CMC regulatory strategy and manage regulatory activities and timelines for one or more investigational and marketed products
    10 Collaborate with EU & International regulatory colleagues in development of global CMC regulatory strategies.
    30 Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies.
    10 Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines.
    10 Provide CMC regulatory guidance to project / product teams.
    10 Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations.
    This person will be managing projects, NOT people.
    This person will be supporting the Manager on the projects she runs (4 total) depending on workload.
    Will be doing basic compliance submissions, post approval submissions, change control evaluations.

     

    Must Have:
    Bachelors Required
    At least 2-4 years of Regulatory Strategy, specifically CMC experience (chemistry manufacturing and controls)
    The Biotech background is absolutely necessary. They need to have worked on (large molecule-biotech) programs.
    They need a technical background in the CMC area (analytics, process development, manufacturing)
    Biologics/bio-technology background necessary.
    Manager wants someone who can easily take direction, ask questions, and then go off and complete project.


    0 0
  • 10/28/15--04:22: Sr. Clinical Trial Manager
  • Position Summary:

    The Sr. Clinical Trial Manager is responsible for the overall operational planning activities for the implementation and conduct of global studies (clinical trials, observational studies, compassionate use and registries) including data management activities in compliance with GCP’s, SOPs and standards within established timelines and budgets.  The successful candidate will have a wide functional area of expertise, including study planning, implementation, and completion; selection and management of Contract Research Organizations and other outside consultants and vendors, including providing them training regarding the investigational agents and indications; and creation and management of project budgets.

    Responsibilities:

    • Develop timelines for implementation of individual studies and over clinical development programs.  Assist in drafting and developing clinical protocols, Investigator Brochures, Information/Consent forms, Clinical Study Reports, CRF’s, diary cards, training materials, and other clinical documents, as required by the project, including clinical sections of regulatory submissions.
    • Arrange and manage resources to conduct clinical trials, including Contract Research Organization and Consultants.  Assist with identifying and selecting resource providers and evaluating these services on an ongoing basis.
    • Develop and negotiate contracts, including budgets, to ensure required services are contracted as cost-efficiently as possible.
    • Ensure appropriate internal review of contracts and budgets, including coordinating with other functional areas (e.g., Regulatory Affairs, Program Management, Legal), as applicable.
    • Manage budgets and timelines. Ensure that all tasks that contribute to the conduct of a clinical study are completed as scheduled and as budgeted. Appraise their Manager of progress and of any deviations or other situations as they arise.
    • Reviews deliverables from vendors, including Statistical Analysis Plans, Data Management Validation Plans, Data Handling Reports, Clinical Study Reports and Appendices.
    • Chair meetings of internal and external teams to ensure smooth running of clinical programs.
    • Participate in meetings with contractors, Investigator Meetings and, in some instances, site evaluation and initiation visits.
    • Prepare and maintain required internal documentation of Clinical Operations, for example, department and company SOPs, regulatory correspondence.
    • Support regulatory interactions, including filing required documents, communicating with regulatory agencies as instructed, assuring compliance with regulatory guidelines.
    • Provide innovative solutions to unanticipated situations as they arise and contribute ideas to improve department functioning and the future development of clinical programs.

    Job Requirements:

    • BA/BSc degree required, advanced degree optional.  More than 5 years industry experience in clinical research management (CTM-III or equivalent).
    • Direct clinical trial experience working with investigators and subjects / patients.
    • In depth knowledge of global regulatory/industry rules and guidance relevant to registries and clinical research (e.g. ICH, GCP, GMP, Code of Federal Regulations, Promotional guidelines and labeling)
    • A good scientific background for understanding issues relating to the development of immunomodulatory agents.
    • Strong team participation and leadership skills, including good interpersonal and communication skills.
    • Self-starter, able to organize and perform complex tasks with minimal supervision.
    • Ability to seek guidance when required and inform manager of situations as they arise.
    • Minimal travel (less than 10%) 

     

     

     


older | 1 | .... | 777 | 778 | (Page 779) | 780 | 781 | .... | 855 | newer