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Career postings for the Massachusetts Biotechnology Council

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    Primary Duties:
    This position has two primary responsibilities:
    1. Global Health Economics (GHE) Center of Excellence related responsibilities. Function as an Health economic (HE) expert to provide expertise in the design, analysis and dissemination plan(s) of GHE data
    2. Global Health Economics , Outcomes Research and Epidemiology (GHEORE) Product (s) lead responsibility for the coordination and articulation of the integrated GHEORE global product strategy and representation of GHEORE in the company wide product related working groups (Global Value Team (GVT), product development team (PDT), DDT etc.)

    Responsibilities:

    40%
    GHE Center of Excellence Responsibilities
    * Propose, develop and implement GHE studies agreed upon by the GVT in order to maximize commercial opportunities for Shire products
    * Lead the design and execution of GHE studies
    * Ensure effective, efficient and timely execution of GHE deliverables
    * Contribute and collaborate during the product strategy development process and plans for dissemination of HE data
    * Proactively contribute and support the GHEORE Therapeutic Area (TA)/BU lead(s) in the development of the global product strategy and the implementation of the GHE agreed upon deliverables.
    * Provide professional HE consultation to GHEORE Product Leads or other department members (non economists) on HE projects/deliverables regarding strategic or methodological issues related to HE, when needed

    40%
    Product Lead responsibilities
    * Coordinate and contribute to the development of GHEORE global product strategy in support of:
    * Drug development and commercialization programs
    * Go/no go decisions for product candidates
    * Market access plans for global markets and global reimbursement strategy
    * Represent and garner support for the GHEORE product strategy within Shire's product teams such as the GVT, PDT and product marketing teams as necessary.
    * Be the point person for the assigned product(s) across the company for all GHEORE related issues including product strategy, deliverables and a reference point for all problems facing the product team related to GHEORE for the specific product
    * The GHEORE proposed product strategy will by its nature be comprehensive and interdisciplinary including PRO, HE, EPI and OR. The product lead is responsible for :
    * Leading a GHEORE product team
    * Ensuring that the product global strategic needs are identified and addressed by obtaining input from the product teams and the GHEORE product team members from all GHEORE centers of excellence

    10%
    Leadership & managerial responsibilities
    * As a leader of the GHEORE product team provide guidance to enable the product team to function effectively and efficiently
    * Lead effectively the cross-functional product team (s) to influence effective strategy and to accomplish necessary deliverables
    * Provide performance input for team members to their in line supervisors
    * When assuming responsibility over direct reports, provide guidance and career development opportunities and assess their performance
    10%
    Maintain awareness of global HEOR requirements, regulatory legislation, payers and HTA trends & requirements
    * Follow and review current professional literature in order to keep current regarding changing requirements and developing trends in HTA and other reimbursement authorities
    * Follow the HE literature

    Education and Experience Requirements
    Masters degree in Health Economics, Pharmacoeconomics, decision sciences (or similar) with 7 or more years experience in global biopharmaceutical or medical device industry or PhD in Health Economics, Pharmacoeconomics, decision sciences (or similar) with at least 5 years experience.

    Experience in interfacing with internal cross-functional decision making teams, external scientific bodies, & preference for experience with interactions with reimbursement agencies globally.

    Other Job Requirements
    * Travel will be required (up to 20%)
    * Experience and willingness to work in a global environment is essential
    * Recruitment, management, development, and retention of health economists

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodatio

    Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjEyNTI1LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Role:
    The Principal Quality Engineer has two primary duties. The first is to lead Shire's global medical device and combination product Quality System initiatives. S/he will partner with Shire's Quality System business process owners to ensure Shire's medical device and combination product development and post-market processes and procedures are sustainability compliant. S/he will be responsible to set strategies, drive implementation, and actively manage related change and communications.
    The second is to provide technical quality leadership and support for Shire's medical device and combination products. S/he will partner with internal and external partners for product development efforts to ensure product design history and risk management files are in accordance with FDA 21 CFR requirements and international standards (e.g., ISO, AAMI, ANSI). S/he will be responsible to lead quality planning and risk management activities, as well as to provide sustaining engineering support through post-market surveillance, design changes, etc.

    Responsibilities:
    70%:
    Lead medical device and combination product Quality System initiatives. Develop strategies, priorities, and plans as required. Drive execution to plans, lead stakeholder meetings/ communications, and complete status reports. Work with external consultancy as required. Manage contract resources as required. Manage associated budget as required. Build strong working relationships with Quality System business process owners, and cross-functional colleagues located both in the US and internationally.

    20%:
    Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities. Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities. Lead design control gap assessments, remediation planning, and remediation execution as required.

    5%:
    Partner with external design/development and/or manufacturing partners on development activities, including risk management, quality planning, and design transfer.

    5%:
    Partner with QA and CMC teams to provide technical quality support to root cause investigations, change control impact assessments, and risk management activities throughout product lifecycle.

    Education & Experience Requirements:
    * BS and/or MS in engineering or equivalent technical discipline required, and advanced degree preferred
    * 10+ years of medical device quality engineering experience required
    * Extensive knowledge of global Quality System requirements (specifically 21 CFR Parts 4, 803, 806, & 820, and ISO 13485) required
    * Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820.30, ISO 13485 7.3, ISO 14971), as well as other applicable standards required
    * Experience in leading quality initiatives, managing cross-functional projects, and driving organizational change required
    * influencing senior management required
    * Experience implementing and/or improving global medical device Quality Systems required
    * Experience with statistical and six sigma methods required, and Black Belt preferred
    * Experience with product lifecycle risk management processes and tools required
    * Experience with post-market support processes (including management review, complaint handling, medical device reporting, and CAPA) required
    * Experience with Class II and/or III medical devices required, and experience with combination products preferred
    * Strong communication skills (both written and verbal), including experience presenting in front of and influencing senior management required

    Key Skills, Abilities, and Competencies:
    * Comprehensive knowledge of the specified technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
    * Performs work without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
    * Understands business environment and relates extensive knowledge of internal and external technological activities to trends. Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units.
    * Provides technical leadership to business units. Participates in the development of other technical contributors by facilitating training and providing feedback and guidance. Acts as a mentor to less-experienced staff and may provide work direction or supervise other technical employees. Exercises judgment independently.

    Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

    Application URL:http://www.aplitrak.com/?adid=bGF1cmVuZC43NDM5Ni4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ


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    Org Marketing Statement
    A career at Pfizer offers opportunity, ownership and impact.

    All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

    Role Description
    The person in this position is responsible for management of the Andover Liquid Dosage Manufacturing (AN-LDM) Operations Line in the PhRD Clinical Manufacturing Group. The AN-LDM Operations Lead provides oversight and coordination of manufacturing operations supporting GMP manufacture for clinical drug product materials. The person in this position additionally is responsible for the performance and development of employees within the line.

    Responsibilities
    * Provide effective leadership of the AN-LDM Operations Team through motivation and engagement in a dynamic environment and work collaboratively in a cross-functional team structure.
    * Use experience in aseptic drug product manufacturing to support process development, troubleshooting and continuous improvements activities.
    * Champion a strong quality culture and balance the business requirements of early stage clinical manufacturing with appropriate controls.
    * Manage operations scheduling and most effectively plan, prioritize, delegate and organize facility resources.
    * Serve as the AN-LDM operations point of contact for manufacturing activities including development work, technology transfer, facility preparation, process execution, and summary reporting. Communicate proactively with stakeholders and management on issue resolution and manufacturing strategies.

    Qualifications
    * BS in a science discipline with 10+ years relevant experience
    * Strong experience with cGMP aseptic manufacturing of parenteral drug products.
    * Self-motivated and be able to adapt to rapidly changing project priorities.
    * Strong oral and written communication skills and the ability to effectively manage project timelines through direct and in-direct influence.
    * Prior management experience including working with cross functional teams.
    * Mechanical aptitude

    PHYSICAL/MENTAL REQUIREMENTS:
    * Periodically may require moving heavy equipment (up to ~50 pounds), standing for long periods of time, and/or significant walking throughout the facility.
    * Position is first shift Monday through Friday.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
    * Position required qualification for aseptic gowning
    * Off shift operational support will be required periodically (~twice a month).

    EEO & Employment Eligibility
    Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

    Application URL:http://www.aplitrak.com/?adid=amlsbC5jdXR0aW5nLjAwODk3LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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  • 01/06/16--00:44: Research Associate II
  • OVERALL RESPONSIBILITY
     The Broad Institute provides a vibrant research environment with close links to top academic institutions across the Boston Area and provides the potential for your contributions to be used and recognized worldwide. One of the goals of the Broad Institute Cancer Program is to bridge the gap from annotated disease variants to biology.

    To achieve this goal, a multi-disciplinary team has formed to pilot cutting edge functional genetic methodologies, create high quality genetic reagents, develop signature-based and phenotypic assays and establish analytical methods in collaboration with the Broad community. In vitro and in vivo functional genomics, using CRISPR/Cas9 and orthogonal mutagenesis approaches represent a major component of the Team.

    We are scaling up efforts to deploy these tools across a panel of human cancer model systems that are capable of reading out cancer-related phenotypes. These cancer model systems are currently being used to screen cancer alleles to identify novel tumor promoters, inform genome-guided therapies and deepen our understanding of therapeutic dependencies. Our team is looking to expand these efforts and is looking for a highly motivated research associate to join the team.The candidate will culture human-derived cancer cell lines, design high-throughput biological assays and deploy these assays into functional genomic experiments at scale.

    He/She will work with wet-lab biologists, dry-lab computational biologists and the Broad Genetic Perturbation Platform to maximize the success, impact and transformative potential of these experiments. He/she will be part of a team that evaluates new technologies and approaches to create new, highly relevant in vivo cancer models.The candidate is expected to work largely independently on a daily basis after training, but will be closely mentored by a Research Scientist and others.

    CHARACTERISTIC DUTIES
    Learn and execute existing pipeline for the design of CRISPR genome editing tools.Handles cell culture of human derived cancer cell lines for high-throughput use. Uses established protocols and collaborates with Broad platforms/facilities for BL2+ and in vivo work.Process screening samples for downstream molecular biology.Works with others to refine protocols, explore novel techniques and to incorporate them into a pipeline to establish the most relevant model systems for annotating disease variants.Operates and maintains laboratory equipment to complete investigations.Prepares, orders, and maintains stocks of necessary reagents, solutions and suppliesDocuments, compiles, and carries out basic analyses of experimental data. Attends team meetings to share results, plan projects and experiments

    SKILLS AND ABILITIES:
    Strong interpersonal, communication and organizational skills, including the ability to handle a variety of tasks in a fast-paced environment, and attention to detail are required. Must be an exceptional team playerMust possess a high level of initiative and the ability to work with little supervision.

    QUALIFICATIONS
    B.S./B.A. in Biology or related field required. RA I: 0-2 yrs of experience working in a scientific research setting a plus. RA II: At least 2 yrs work in a scientific research setting, preferably with functional genomics experienceRA III: 3+ years work in a scientific research setting, with extensive functional genomics expertise, preferably with high-throughput screening experience (genetic or small molecule). Familiarity of basic cell culture and molecular biology laboratory techniques strongly desired.

    The Broad Institute will not offer visa sponsorship for this opportunity. EOE / Minorities / Females / Protected Veterans / Disabilities

     To apply for this position, please CLICK HERE


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    We are seeking a highly motivated individual to join the Broad Institute as an Associate Clinical Director for the Clinical Research Sequencing Platform (CRSP). ResponsibilitiesThe Associate Director, of the Clinical R&D Sequencing Platform, under the supervision of the Clinical Director and, in accordance with established regulatory policies, provides technical supervision, clinical consultation, and compliance support to the CRSP clinical lab group. This individual assumes clinical consultant and technical supervisor responsibilities as assigned by the Clinical Director.

    This individual will provide guidance on the development and validation of laboratory tests as well as the application of regulatory policies to testing operations. In the absence of the Clinical Director, the Associate Clinical Director will be responsible for the clinical regulatory administration of the laboratory, including recording and reporting of test results promptly, accurately and proficiently, and assuring compliance with the applicable state and federal regulations.

    The Associate Director must be accessible to testing personnel to provide on-site, telephone, or electronic consultation to resolve technical problems in accordance with policies and procedures established by the laboratory.

    The responsibilities of the Associate Director may include the following:
    Being on site to provide clinical and technical guidance when high complexity testing is performed.Monitoring test analyses and specimen examinations to ensure that acceptable levels of analytic performance are maintained.

    Assuring that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications.Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.Ensuring that test reports include pertinent information for test interpretation.Ensuring that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.Ensuring that the laboratory provides orientation to all testing personnel.Ensuring that the laboratory evaluates the competency of all the testing personnel and that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. Interacting with clients and ordering health care professionals and addressing questions regarding testing and services offered by CRSP.Providing technical and strategic support to the wider Broad Genomics group on technology evaluations, methods development, continuous improvement, and translational product development.

    This person will also be responsible for contributing to the development and implementation of computational tools and clinical approaches for genetic analysis of rare disease patients, for analyzing whole genome, whole exome and RNA sequencing data sets across hundreds of rare disease families, and for interpreting candidate causal variants found using these data sets. These responsibilities may include the following:Apply computational tools to genomic data sets from rare disease families and identify candidate causal variants, working closely with clinical collaborators. Work closely with software developers to implement and test new methods for rare disease analysis.Develop improved strategies to collect and use clinical and genetic data to enhance the interpretation of variants from rare disease families.

    Work with computational biologists to develop strategies for incorporating non-coding and copy number variation detection strategies to aid in identifying the causes of rare disease.Assist in data sharing strategies to enhance rare disease gene discovery including participating in the Matchmaker Exchange consortium to develop federated models of data sharing. Assist in the preparation of manuscripts describing rare disease analyses and new genes identified in our rare disease cohorts.

    Qualifications
    PhD in Genetics or a related field is required.ABMG certification in Clinical Molecular Genetics is desired.

    Experience in genomic tool usage and gene discovery preferred.Experience in molecular diagnostics including understanding clinical disease and variant pathogenicity preferred.Excellent written and oral presentation skills, communication and interpersonal skills. Demonstrated attention to detail, and strong initiative and ability to take ownership of assigned tasks and projects. Able to work effectively in a team environment and be flexible and able to respond to shifting priorities in a dynamic setting

    EOE/Minorities/Females/Protected Veterans/Disabilities #LI-DNP

    To apply for this position, please CLICK HERE


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  • 01/06/16--02:20: Research Associate
  • The position resides within the Broad Infectious Disease Program. Responsibilities center on the development, optimization, and systematic application of cutting-edge methods for generating high-throughput sequencing data to address key questions relating to infectious disease and the human microbiome.  

    The candidate will work independently as well as with team management and scientific staff in a highly dynamic research environment.  The candidate will be encouraged to use their creativity and initiative to develop, optimize, and execute a variety of protocols, helping to coordinate and ensure the timely completion of goals for diverse projects.

    CHARACTERISTIC DUTIES;
    Collaborates with manager and scientific staff to successfully complete IDP goals, including DNA and RNA library design, construction, and testing for next-generation sequencing. ;Responsible for acquiring the in-depth knowledge and hands-on expertise in all required molecular biology procedures. Demonstrates flexibility to execute tasks requiring various skill levels. ;Performs analyses of current processes and identifies opportunities for improvement.

    Proposes and evaluates changes in molecular biology procedures to ensure output of high-quality genomic reagents. ;Responsible for execution of production projects, working with other team members and leadership to plan project requirements and timelines. Identifies and helps solve methodological problems and adjusts experimental protocols to ensure successful project completion in a timely fashion. ;Interacts and coordinates with vendors to address and investigate novel molecular biology reagents, techniques and equipment. ;Compiles and analyzes all experimental data in a timely fashion, and adjusts design as necessary. Discusses problems with team Manager in a timely manner.;Other related tasks as required by Manager.

    Education :
    Qualified candidates should possess a B.S. in microbiology, biochemistry, cell/molecular biology, or related field, with at least 2 years of research experience (can be concurrent with the undergraduate degree).

    Experience:
    - Minimum of 2 years of relevant professional experience in a molecular biology environment required.
    - Experience in a high-throughput laboratory a plus.;Solid knowledge of DNA cloning and PCR is preferred.;Solid knowledge of RNA approaches (RNA-Seq) is preferred.;
    - Excellent experimental skills and a strong background in the latest molecular biology and genomics methodologies a must. ;
    - Excellent critical thinking and analytical skills required.;Must have strong organizational skills.;
    - Excellent communication and interpersonal skills and the ability to interact with multidisciplinary staff in a fast-paced environment required.;
    - Must have experience that demonstrates the ability to carry out a variety of tasks in parallel, recognize and solve problems effectively, and shift priorities rapidly.
    - The Broad Institute will not offer visa sponsorship for this opportunity.  

    EOE / Minorities / Females / Protected Veterans / Disabilities

    To apply for this position, please CLICK HERE


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  • 01/06/16--05:21: Senior Compliance Specialist
  • Position Summary

    This position is responsible for batch records, media disposition, label issuance and reconciliation, archiving, final product packaging / release to the courier, Customer Complaints, Deviations, CAPA, Tasks, Effective Reviews, Investigations,  communicating product deviations to the physician, Product Interdiction, Quality Metrics, interdepartmental audits, write and /or revise Standard Operating Procedures.

    Core Responsibilities

    • Assist in performing review of results to audit process or equipment compliance to FDA and GMP requirements.
    • Support the remediation efforts for standard operating procedures.
    • Accountable for project completions and achievement of compliance goals.
    • Interact with Operations project teams and research groups as they impact the quality operation.
    • Perform department audits to ensure compliance to GMPs and Vericel requirements.
    • Address and/or escalate compliance problems and issues.
    • Support day to day operations. Including: batch record review, label issuance, archiving, and verification.
    • Manage critical, major and minor deviations, CAPAs and tasks within TrackWise.
    • Perform and monitor investigations within the CATSWEB system.
    • Participate in other investigations and corrective actions.
    • Communicate product deviations to the physician.
    • Product Interdiction.
    • Write and /or revise Standard Operating Procedures.
    • Participate in the Quality Metrics.
    • Perform risk assessment, root cause analysis, and data interpretation. 
    • Utilize organizational and time management skills to meet project milestones.
    • Effectively demonstrate an understanding of CGMPs and how it applies to specific responsibilities.
    • Work independently under general supervision and direction. 
    • Work in compliance with cGMPs.
    • Practice safe work habits and adheres to Vericel’s safety procedures and guidelines.

    Basic Qualifications:

    • Bachelor's degree or equivalent.
    • 4+ years of experience in a quality unit within the pharmaceutical/biotech industry. 
    • Experience with Regulations for the pharmaceutical/biotech industry. 
    • Able and willing to work Tuesday - Saturday

    Preferred Qualifications:

    • Basic knowledge of GMP regulations.
    • Strong organization and time management skills.
    • Experience with Electronic Quality Management Systems (TrackWise, Plateau, Livelink).
    • Knowledge of GMP regulations.
    • Proficient in MS Word, Excel and PowerPoint.
    • Strong organization and time management skills.

    All qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.


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    Research Associate – Biology (Job code RAJM)

    The Biology Department is seeking a Research Associate to conduct oncology target validation and drug discovery project support in a highly collaborative, goal-oriented team environment. The position requires excellent time management skills and hands-on experience with commonly used techniques in molecular and cell biology.

    Requirements:

    • B.S./M.S. degree in life sciences with at least 1 year of relevant research experience in an academic or industrial setting. Experience in cancer biology and/or chromatin biology is a plus.
    • The candidate will be expected to conduct hands-on laboratory work to generate and analyze data. You will be responsible for designing and executing cell-based phenotypic and mechanism of action studies using a variety of assay platforms.
    • Strong communication and organization skills, keeping good scientific records, and giving updates at team meetings are required.
    • Detail oriented with the ability to work in a fast paced environment under tight deadlines.
    • Flexibility and willingness to work across diverse areas, ability to develop and evaluate novel assays for a wide variety of biological/phenotypic endpoints and to support general research activities within the group.

    Key Skills required:

    • Mammalian cell culture experience with tumor cell lines or primary cultures, including assessment of proliferation, cell cycle progression and apoptosis..
    • In depth knowledge of cell and molecular biology techniques including transfection (cDNA, siRNA, shRNA and/or CRISPRs), retro/lentiviral production and transduction, quantitative PCR, cloning/mutagenesis, and protein analysis – immunoprecipitation, SDS-PAGE/Western blots.
    • Good working knowledge of MS office, data analysis and graphing software

    Constellation Pharmaceuticals is an Equal Opportunity Employer, and offers a comprehensive benefits package, including health, dental, 401(k), paid vacation, tuition reimbursement, and much more.

     


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    Join bluebird bio’s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approaches.  bluebird bio seeks a passionate and driven scientist/engineer to manage lentiviral vector production activities, a critical starting material to the generation of our final gene therapy products.   We seek candidates with proven ability to successfully work independently and collaboratively with CMOs and across functions to achieve optimized project plans, with the ultimate goal to deliver therapies that transform the lives of patients.

    About the role:

    • Manage lentiviral vector production programs, as both the technical expert and the operational lead.
      • Provide technical support of GMP manufacturing runs for ongoing clinical studies
      • Be the primary technical point of contact with contract manufacturing organizations (CMOs) and manage day-to-day operations as needed.
    • Work with supply chain function to ensure the clinical supply of lentiviral vectors for drug product manufacturing.
    • Proactively manage timelines / deliverables and drive timely / successful execution of technology transfer to and clinical campaigns at CMOs including raw material and equipment procurement
    • Generate, manage, evaluate, and maintain critical data in a highly organized manner. Author technical reports, tech transfer documents, and prepare scientific presentations as needed. Write/revise SOPs as needed.
    • Work closely with QA and CMOs as applicable for successful resolution of deviations, CAPAs, Change Controls, etc.
    • Conduct onsite or offsite training of contract manufacturing personnel on manufacturing processes
    • Be the person in plant for process engineering or training runs, as necessary
    • Conduct internal technology transfer meetings and interact effectively with cross functional departments
    • Frequent travel to CMO locations (including weekends) may be required

     

    About you:

    • BS in (bio)chemical engineering or biological sciences with 8+ years, MS with 6+ years, or a PhD with 0-2+ years of industrial experience in cGMP manufacturing of biologics or viral products technical operations. 
    • Technology transfer experience (particularly with external CMO) is preferred; Demonstrated experience of proactively driving timely and successful execution of technology transfer to and clinical campaigns at CMOs.
    • Strong understanding of applicable regulations and standards (GMP, GTP and/or AABB)
    • Prior cGMP cell or gene therapy manufacturing experience for clinical-stage products is highly favorable
    • Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately
    • Experience with either aseptic cell culture and downstream processing operations (membrane filtration and chromatography) is required, and experience with both is preferred. 
    • Candidate should have a basic understanding and experience with general lab techniques such as gel electrophoresis, ELISA assays.
    • Working knowledge of various computer software, hardware, and standard office systems sufficient to record scientific data and results, and prepare reports.
    • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
    • Independently motivated, detail oriented and good problem solving ability
    • Proficient with timeline project tracking using MS Project
    • Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
    • Ability to execute and follow-through to completion and documentation.
    • Excellent communication skills and ability to influence across multiple functions.
    • Must be willing to have a flexible schedule based on experimental and company needs (including possible travel)
    • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

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  • 01/06/16--07:15: Patent Attorney
  • Clark+Elbing LLP is seeking patent attorneys to join our firm. Qualified applicants must hold a PhD or equivalent degree in Biology, Chemistry or a related field of study, be a member of the patent bar, and have at least 3-5 years of patent drafting and prosecution experience. Candidates must also have strong academic credentials, outstanding written and oral communication skills, and excellent interpersonal skills.

    If you are interested in applying, please send an email to Dawn Langan, Human Resources Manager at legalcareers@clarkelbing.com.  Please include a cover letter, résumé, and recent writing sample.

    For more information, please visit www.clarkelbing.com.


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  • 01/06/16--07:50: Research Associate
  • Quanterix is an exciting early-stage commercial company whose mission is to develop a game-changing platform based upon its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company has launched an instrument for the life sciences and diagnostics industries. With unprecedented sensitivity, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications.  To continue our solid growth, we are seeking an experienced, talented and highly motivated Research Associate to join our Accelerator laboratory team that utilizes Simoa to fulfill services for our customers. You will be working in a fast-paced environment, on multiple projects, and will be a part of a rapidly growing company on a trajectory to have a major impact in the life science research and clinical diagnostics arenas.

    Responsibilities will broadly include developing, optimizing and troubleshooting new biomarker assays for Quanterix's proprietary Simoa technology. You will apply your laboratory skills and experience to generate high quality data in support of a diversity of projects, which will include both immunoassay development and validation as well as testing and analysis of clinical samples using commercial kits.  The successful candidate will be responsible for specimen processing, developing and running Simoa assays, analysis and interpretation of data, and writing in-depth reports.  This is a customer facing position that will also require interaction with clients to develop assays, review results and address technical questions.  A demonstrated ability to follow SOPs and document results is also important.

    Requirements:

    • S in Chemistry, Biochemistry, or Life Sciences
    • At least 2-5 years of experience in immunoassay development preferred
    • Desired experience includes ELISA development and optimization, assay protocol optimization and validation
    • Experience in the following areas is a plus: conjugation chemistry, e.g. conjugating antibodies to solid surfaces (microbeads), biotinylation, process improvement techniques
    • Excellent technical writing and oral communication skills
    • Self-motivated with critical eye for detail
    • Strong organizational skills critical for ability to manage multiple projects

     

    You must be detail oriented, and have excellent organizational, record keeping and communication skills.  Also, a strong work ethic to generate high quality data under tight deadlines and a collaborative and proactive attitude is a must.

    About Quanterix:

    Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.


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  • 01/06/16--08:21: Mechanical Engineer
  • Mechanical Engineer Lexington, MA

    Quanterix is an exciting early-stage commercial company currently developing a transformational platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company has launched an instrument for the life sciences research industry.   With unprecedented sensitivity, precision, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications.   Quanterix is looking to hire an experienced Mechanical Engineer to join our growing System Integration, Test, and Validation team within the Engineering Organization.  

    Responsibilities:

    • Provide mechanical design and sound engineering analysis support in the pursuit of continuous improvement initiatives for existing products.
    • Work with broadly cross-functional teams (and with external partners) beside other engineering disciplines to create drawings, models, and analyses necessary for prototyping, characterizing, integrating, and testing highly reliable, creative new products.
    • Create innovative, research-focused components, breadboards, and fixtures.
    • Document SOPs to implement best-in-class SolidWorks modeling, drafting, and BOM management practices including configuration and revision control systems.  This individual will also be responsible for administering the non-IT aspects of SolidWorks.  It is expected that as a subject matter expert, the individual will additionally provide training for peers.
    • Act as a technical representative on development project teams.
    • Develop and, as needed, execute methods for characterization and/or verification of engineering designs.

    Skills and Experience Requirements:

    • Bachelor's Degree or higher in mechanical engineering, physics or other fields with a heavy physical science/engineering emphasis. Master’s degree highly desirable
    • Experience with SolidWorks 3D CAD and SolidWorks PDM, 3+ years.  Administrative experience highly desirable.
    • Experience with automated in vitro medical diagnostic platforms and technology, 3+ years.  Experience or familiarity with immunoassay platforms is highly desirable.
    • Strong engineering analysis fundamentals (capable of manually producing first order approximations as well as gaining deeper insight through the use of FEA or other computational assisted analyses)
    • Systems integration and/or engineering familiarity is highly desirable
    • Willingness to work in a lab environment to build, test, or otherwise operate Quanterix systems
    • Strong statistical methods knowledge and experience
    • Product Development Process, verification, and validation experience
    • Excellent technical communication and writing skills
    • Collaborative spirit, positive attitude, strong work ethic

    About Quanterix

    Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.


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  • 01/06/16--08:29: Systems Integration Engineer
  • Quanterix is an exciting early-stage commercial company currently developing a transformational platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company has launched an instrument for the life sciences research industry.   With unprecedented sensitivity, precision, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications.   Quanterix is looking to hire an Engineer or Scientist  to join our growing System Integration, Test, and Validation team within the broader Engineering Organization.  

    Responsibilities:

    • Work with broadly cross-functional teams (and with external partners) beside other engineering disciplines to integrate, characterize, and test creative new diagnostic medical devices.
    • Drive innovative integration of hardware, software, and chemistry into well characterized, robust, reliable systems.
    • Act as a technical representative on development project teams.
    • Design and execute experiments in a laboratory environment.
    • Develop/document methods or procedures, execute them, and create reports for integration, characterization, and/or verification of engineering design improvements on existing systems and new products under development.

    Skills and Experience Requirements:

    • Bachelor's Degree or higher in one of the physical sciences or engineering disciplines. Master’s degree highly desirable.
    • Experience with medical devices or analogous systems is required.
    • Understanding of immunoassay, surface chemistry, and automated liquid handling is highly desirable.
    • Systems Engineering and/or Integration experience is highly desirable.  Systems Thinking experience a strong plus.
    • Must be willing to spend time working in a lab environment to build, test, or otherwise operate Quanterix systems.
    • Strong statistical methods knowledge and experience.
    • Excellent technical communication and writing skills.
    • Collaborative spirit, positive attitude, strong work ethic.
    • Domestic and international travel required (although it’s not frequent).

    About Quanterix

    Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.


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    Quanterix is looking to hire an organized, results-driven team player to join the Field Service organization as a Manager for Technical Support.  This role will be based in Lexington, MA leading the team which is the first point of contact for customer support technical questions regarding hardware, software, IT and assay related questions.  This position will report to the Director of Field Service.  Primary responsibilities for the successful candidate will be: to effectively coordinate the worldwide technical support queue and customer response; interact with customers on a daily basis answering technical questions and communicating the response to customer inquiries; provide support for engineers in the field requiring assistance; maintain and create service manuals and technical field instructions; and management of service part inventory.

    Specific responsibilities include:

    • To maintain customer response to technical support queue and maintain contractual response times. Lead coordination of technical support team members in order to ensure timely and thorough customer response.
    • Provide real-time and follow-up support (software, technical, operational, electro-mechanical and logistical) to our customers, both internal and external.
    • Partner with appropriate internal experts (manufacturing, engineering, R&D, sales, etc.) to author a plan of action to resolve customer issues quickly and effectively
    • Log and track all support calls in the Technical Support database. Provide regular updates on key customer satisfaction metrics. 
    • Coordinate with service parts buyer/planner to review safety stocking levels and on-time service part delivery levels, including supply tracking of part returns from field to manufacturer for repair.
    • Coordinate and assign duties for writing Technical Service Bulletins, field service manuals and service part kit instructions. Review content with technical writers.
    • Dispatch Field Service Engineers as required
    • Report quality issues via corrective action process and coordinate response with Quality team.
    • Document internal processes and continuously suggest improvements to current processes

     

    This individual will be expected to:

     

    • Provide calm, effective leadership to Technical Support Team solving immediate issues while instituting and modifying processes to prevent them in the future
    • Provide customers with prompt, courteous, and effective service and support at all times
    • Be an effective communicator – with stellar written and verbal communication skills
    • Drive the appropriate resources to timely resolutions
    • Be comfortable managing several deliverables at the same time, prioritizing and re-prioritizing as needed

     

    Qualifications:

    • Requires an AS degree or equivalent in the area of Electro-mechanical systems or prior military experience in this technical arena. BS in Engineering or Software Engineering preferred.
    • 5+ years of successful experience in a Technical or Field Service role. Previous management or team lead experience preferred. 
    • Demonstrated ability to communicate issues clearly within entire organization and solve problems independently.
    • Ability to be persuasive while maintaining business relationships.
    • Ability to work in a team environment and to meet deadlines is required.

     About Quanterix

    Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts, USA with rapid global expansion – including this position supporting our European customer base. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.  For more information, visit us at www.quanterix.com


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    Quanterix is an exciting early-stage commercial company currently developing a transformational platform that combines proprietary single-molecule sensitivity, multiplexing and full automation with its revolutionary Single Molecule Array (Simoa) technology.  Located in Lexington, MA, the company has launched an instrument for the life sciences research industry.   With unprecedented sensitivity, precision, multiplex capabilities, and full automation, Simoa offers significant benefits for both research and clinical testing applications.   Quanterix is looking to hire an experienced Quanterix is looking to hire an experienced Assay Technical Support Scientist to join our growing Operations team.  

    Responsibilities:

    • In this critical role, this individual will be the assay technical expert to support the product launch and product lot release processes.  Specifically, this individual will: Support the kit lot release process when technical issues arise and lead assay root cause investigations. Key interactions are Manufacturing, Quality Control and Assay Development.
    • Act as a technical representative on new assay development project teams. Key interactions are the Assay Development team and Operations Team.
    • Will develop and, as needed, execute methods for qualification of critical raw materials (e.g., polyclonal antibodies). Key interactions are Procurement, Quality Control and Quality Assurance.

    Skills and Experience Requirements:

    • Masters Degree or higher in biology, chemistry, or biochemistry
    • Strong experience with automated immunoassay platforms and technology, 3+ years
    • Strong statistical methods knowledge and experience required
    • Product Development Process and verification and validation experience required
    • cGMP and/or ISO-certified facility experience preferred
    • Excellent technical communication and writing skills
    • Leadership capabilities
    • Team spirit, positive attitude, strong work ethic

     About Quanterix

    Quanterix Corporation is a privately held, dynamic and growing company located in Lexington, Massachusetts. We are building a team of best-in-class scientists, engineers and business professionals that thrive in a collaborative high-energy entrepreneurial environment. We believe that the commercialization of an enabling technology with the potential to revolutionize life science research and clinical diagnostics will require the very best people working together and exchanging ideas while sharing a commitment to innovation. Quanterix is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits package, including health, dental, life insurance, a flexible spending plan, paid vacation, stock options and a 401(k) investment plan.


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    At Novartis Oncology, we are passionate about the discovery and development of innovative medicines. We seek to provide a broad range of new therapies to transform the way patients live with cancer. We are seeking an experienced cancer biologist to lead our target discovery and validation group.

    Responsibilities include:
    • Lead a group of around 15 scientists performing cutting edge science to discover and validate novel targets in oncology
    • Represent the Cambridge TIDVAL Group within the Global TIDVAL Core Team, contribute to shape the Global Oncology TIDVAL strategy and operationally coordinate activities across sites and functions
    • Contribute to overall strategic vision of Oncology research as a member of the local leadership team 
    • Identify new technologies and new approaches to discover targets in cancer
    • Identify, build, and manage new collaborations with external academic and industry groups 
    • Interface with key leaders and scientists within Oncology research and across organizations within Novartis Institutes for BioMedical Research (NIBR) 
    • Ensure coordination and collaboration with the oncology bioinformatics, NIBR-IT and technology platform groups to support and build information systems supporting target discovery  

    ADDITIONAL REQUIREMENTS

    • PhD in Biology, Cellular & Molecular biology, or a related field, with 5+ years of leadership and management experience
    • Strong publication record in cancer research
    • Demonstrated ability in establishing effective collaborative relationships in a global environment and with cross functional scientific teams 
    • Strong communication skills and ability to represent the group within NIBR and throughout the wider scientific community
    • Demonstrated organizational skills, aligning available resources to meet goals within a matrixed environment.
    • In-depth knowledge of cancer biology, functional genomics approaches and understanding of state-of-the-art bioinformatics
    • A demonstrated track record in oncology drug discovery would be an advantage.


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  • 01/05/16--22:55: Research Technician
  • No of Openings:               3

    Work Schedule:                Can work weekends and/or weekdays

    Hours per Week:              10-20

    Wage/Salary:     $13-$16/hr DOE

    Compensation Details:  Entry-level position(s) open

    Required 10hr/week minimum

    Biology or related major required

    Fees Required to Apply/Participate:       

    *Approx. Employment Start Date:           1/18/2015

    Employment End Date: TBD

    Supervisor:         Giovanni Musto

    *Job Description:            

    We are looking for a driven individual that demonstrates strong attention to detail.

    Job duties include:

    cleaning beakers and other items

    organizing lab space

    inventory management

     

    This is an entry-level job. For the first month, you will be organizing, cleaning, and creating the foundation for our newest product lines. You will be working with lab management software and closely with very experienced scientists. Depending on your commitment level, you can learn how to run ELISA kits, Western blots, mini prep, midi prep and many others.

    *Qualifications: Work 10+ hours/week

    Lift 35+ pounds

    Problem solve creatively

    Commit to 3+ months

    Biology or related major required

    *Application Instructions & Deadlines   :

    Please send a job specific resume and cover letter to musto@neobiolab.com. I will review only applications that have both.

     

    Thank you for your interest! We are excited to have up to 3 new members as part of our team.


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  • 01/05/16--23:19: Director, Human Resources
  • Director of Human Resources (consultant)

    Reporting to the President of Alcresta, the Director of Human Resources will lead all HR initiatives, programs and operations in support of our rapidly growing commercial stage company. This leadership position will drive all talent management strategies and programs including talent acquisition and development, rewards and recognition, employee engagement and retention, organizational design and compliance.

     Responsibilities:

    • Partner with senior management on workforce planning strategies, hiring plans and recruitment and selection strategies.
    • Ensure successful onboarding and orientation for all new hires; design and implement initiatives that facilitate rapid assimilation.
    • Provide counsel to senior management on HR talent management and engagement strategies including, career development, training, recognition and compensation.
    • Coach Managers on employee relations matters including performance management, workplace concerns and employment legislation.
    • Administer benefit programs; advise employees on open enrollment process, benefit eligibility and coverage, oversee the maintenance of benefit records and ensure the necessary documentation is processed to implement desired benefit coverage.
    • Ensure compliance with all state and federal employment programs and practices.
    • Establish HR metrics and regular management reporting.

     

    Qualifications:

    • BA/BS degree
    • 8+ years’ of broad HR generalist experience
    • Demonstrated experience overseeing core HR programs in talent management, compensation and benefits, engagement and compliance
    • Demonstrated ability to establish strong relationships with key business partners and executive leadership
    • Ability to think strategically while executing at a detailed level
    • Results-oriented with a strong sense of urgency
    • Self-motivated and capable of working independently as well as with a team
    • Excellent communication skills
    • Life sciences experience in a commercial environment strongly preferred

    Please note: will consider part-time applicants 

     


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    General Scope and Summary

    Accountable for Data Management activities that support development and future commercial projects worldwide.  Participate as an active member of a multi-disciplinary team to plan and manage the Data Management tasks required for phase 1-4 studies.  Drive the delivery of end-to-end study data quality and integrity from source through publication/submission to archiving.  This position will report to the Director of Clinical Operations and Development until the Head of Data Science/Biostatistics is hired.

    Roles and Responsibilities

    • Lead Phase I – IV Data Management teams comprising internal and external data management resources.  Manage clinical trials data or data management projects under aggressive timelines in a high quality and professional manner.  Identify requirements for capture and processing of clinical data ensuring accuracy, consistency and completeness while adhering to SOPs and work guidelines as required. 
    • Oversee Data Management vendors – review and approve all DM documentation; maintain all data management internal files, ensuring preparedness for regulatory inspections.
    • Develop data management SOPs and processes.
    • Oversee the design, creation and testing of clinical study databases. 
    • Primarily responsible for creating and adhering to Data Management timelines and budget.
    • Review protocols for proper data capture including electronic Case Report Form design. Able to perform a thoroughly detailed review of eCRF data requirements.
    • Ability to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications.  
    • Designs and or reviews eCRFs, annotated eCRF, eCRF completion guidelines, Data Management Plans detailing complete data management processes throughout clinical studies.
    • Oversee development of data edit check specifications and manual data listings as required.
    • Responsible for review of medical coding, database lock and freeze, and SAE reconciliation activities performed by external vendors.
    • Functional representative on project teams, study teams, development teams including multi-disciplinary interactions.

    Experience, Education and Specialized Knowledge and Skills

    • BA/BS, preferably in the scientific/health care field.
    • At least 8 years in Data Management for the pharmaceutical/biotechnology industry.
    • Experience as lead DM of a Phase III study required; ability to be primary DM representative with little oversight required.
    • Experience is CNS/Neurology preferred and experience with orphan indications will be favorably considered.
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
    • Understand the scope and focus of clinical trials phase 1-4 and have a proven ability to perform the tasks, manage vendor resources and timelines. Possesse an in-depth understanding of regulatory guidelines e.g. ICH, GCDMP, 21 CFR Part 11 and their application to Data Management practice. Knowledge of and experience with MedDRA and WHODrug data dictionaries.
    • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesse strong written and verbal communication skills.
    • Able to travel to off-site meetings or training seminars as needed.
    • Possesse solid computer system and technical skills with a strong ability to learn multiple e computer applications. Prior experience with different Data Management systems and technologies, Electronic Data Capture systems (RAVE preferred) and CDISC data standards are desirable.
    • Proficient working knowledge of any of the following strongly desired: SAS, Spotfire or other Visualization Tools, Data Standards management, Clinical Data Warehouse, SDTM.

    Attributes

    • Ability to thrive in a fast-paced, entrepreneurial environment with busy, high-performing colleagues.
    • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
    • Proactive and positive management approach.
    • Maximum flexibility to adapt to changing program needs in real time.
    • Strong leadership skills.
    • Ability to build strong relationships with co-workers of various backgrounds and expertise.
    • Excitement about the vision and mission of SAGE.

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    General Scope and Summary

    Reporting to the VP of Medical Affairs, have primary responsibility to strategically design and implement all health economic and outcomes research activities in support of products across the SAGE portfolio. The candidate will work closely with Clinical Development, Market Access, Medical Communications and Field Medical to ensure optimal collaboration in design and execution of HEOR studies. 

    Roles and Responsibilities

    • Develop and execute HEOR strategies and approaches for products in different stages of development.
    • Partner with Market Access and appropriate cross-functional partners to develop product value propositions that optimize patient access and reimbursement.
    • Identify HEOR evidence requirements and gaps.
    • Design, conduct, and deliver studies and tools to support value demonstration and product differentiation.
    • Provides strategic recommendations to clinical development protocols to ensure product differentiation and value demonstration.
    • Develops and maintains collaborative relationships with US and Global KOLs to implement HEOR analyses, as needed.
    • Develops analysis plans (e.g., for claims database analyses) in collaboration with internal statistician.
    • Oversee development and revision of core value dossiers including AMCP and global value dossier.
    • Manage relationships with vendors to ensure timely completion of high quality projects.
    • Communicate study plans, study methods and results to internal teams.
    • Present health outcomes research findings at scientific congresses and participate in the development and writing of manuscripts for publication in peer-reviewed journals.
    • Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
    • Build strong relationships with internal stakeholders and ensure continuous and consistent communication with key internal partners on HEOR projects.
    • Represent HEOR on cross-functional internal teams.
    • Remain current on HEOR data sources and analytic methods.

    Experience, Education and Specialized Knowledge and Skills

    Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.  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.  Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

    • Advanced degree related to health economics and/or health outcomes research (PharmD, PhD, MD, MPH).
    • Advanced knowledge and experience in conducting health economics, health related quality of life, and/or evaluation of health care interventions.
    • Understanding of the unique dynamics of a hospital critical care center setting is preferred.
    • In-depth knowledge of the health care systems in the U.S. and globally.
    • Intellectual curiosity and intelligence about the field of science/medicine for which they are responsible.
    • Highly motivated and capable of comprehending large amounts of scientific content which is then communicated in a clear, concise fashion.
    • Significant experience and demonstrated track record of success in working independently, self-managing priorities and multi-tasking projects.
    • Familiarity with the academic community and the medical research and medical education process highly valued.
    • Extensive knowledge and HEOR experience in the pharmaceutical or related industries (e.g., consulting).
    • Experience with HEOR strategy and implementation in U.S., EU and global markets.
    • Strong interpersonal and communication skills, able to work independently and within a team environment.
    • Excellent analytical skills, including in-depth knowledge of health economic modeling, PROs and claims database analysis methodologies.
    • Proven ability to successfully manage and execute multiple projects across a variety of health outcomes methodologies and therapeutic areas.
    • Solid understanding of epidemiology and biostatistics.
    • 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 individually, within a multi-disciplinary team, as well as with external partners and vendors.
    • Possesses strong written and verbal communication skills.
    • Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
    • Excitement about the vision and mission of SAGE.
    • Ability to travel approximately 20% time.

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