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Career postings for the Massachusetts Biotechnology Council

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  • 11/04/15--09:30: Medical Writing Group Lead
  • Primary Role:
    The Medical Writing Group Lead (Dir) is responsible for strategically planning and resourcing the medical writing deliverables that support Shire business objectives across a large therapeutic program or multiple programs. The MW Group Lead independently provides strategic direction to cross-functional project teams to ensure that clinical documents (eg, investigators' brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. The MW Group Lead writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and accurate data presentation and interpretation.

    As a member of the MW Leadership Team, the MW Group Lead contributes to the strategic direction of the department and mentors less experienced writers. The MW Group Lead initiates and leads initiatives designed to establish best practices and efficient cross-functional collaboration. The MW Group Lead has direct people management responsibility including performance management, skill development, and fostering a BRAVE culture. In addition, may be responsible for budget and resource allocation pertaining to MW activity.

    The MW Group Lead reports to the Head of Medical Writing.

    Responsibilities:
    35%: Writing, most often the more strategic documents to support the goals of the product(s)/program(s).
    15%: Directing and mentoring MW team members (internal and external) ensuring quality and efficiency in the production of clinical regulatory documents.
    25%: Overseeing the medical writing aspects of the program(s), attending strategic meetings, developing timelines, assessing resource needs, collaborating with cross-functional colleagues
    20%: Leading or participating on departmental or cross-functional initiatives including actively participating on the MWLT
    5%: People management activities including performance management, people development, and fostering a BRAVE culture.

    Education & Experience Requirements:
    * Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor's degree required.
    * 14+ years experience in clinical/pharmaceutical development with directly related medical writing experience.
    * At least 5 years of direct line management experience.
    * Global regulatory submission experience required.

    Other Job Requirements: Less than 10% travel (domestic or international).

    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=YXN0YW5pdHMuMjI1MDkuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20


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    Primary Duties:

    The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological products. This role includes the lead regulatory responsibility for support of global registration and life cycle support, and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.) coordinating support via a Global Regulatory Strategy Team composed of core regulatory support functions.

    Responsibilities:

    25%
    * Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations. Single point of contact and accountability for regulatory and leads the regulatory subteams as well as represents regulatory on key internal decision making teams such as PSTs and GDTs.
    25%
    * Functions as the global regulatory lead for assigned projects, working with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and Intel/Policy to drive global regulatory strategies.
    * Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects.
    25%
    * Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
    5%
    * Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
    * Effectively leads key meetings with HAs to ensure full discussion of issues and opportunities.
    5%
    * Provides guidance to all appropriate departments in Shire to assure compliance with applicable regulations.
    * Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate
    * Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
    5%
    * Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff.
    5%
    * Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
    5%
    * May supervise a changing number of Regulatory Affairs Associates.
    * Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff.

    Education and Experience Requirements:

    * BS, BSc, MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred or equivalent relevant experience.
    * Generally has at least 5-10 years of Regulatory Affairs or equivalent experience. The regulatory experience should be broad to ensure appropriate leadership and mentoring for regulatory staff within Shire.

    Other Job Requirements:

    Likely to involve some domestic and international travel.

    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=amRpZXR6LjI1MTM5LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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    Primary Role:
    Under the direction of the Senior Director of Regulatory Affairs, direct and manage Regulatory Affairs activities for developing and executing CMC strategies across product life cycles. Manage submissions and interactions with the FDA and other regulatory agencies for CMC issues.

    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 may be studied and marketed as planned. coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives.

    Responsibilities:
    25%
    * Develop CMC regulatory strategy and manage regulatory activities and timelines for investigational and marketed products.

    25%
    * Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies.

    25%
    * Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to ensure conformance with regulations and existing regulatory approvals.

    25%
    * Provide CMC regulatory guidance to Project/Product teams. (25%)

    Education & Experience Requirements:
    M.S. / Ph/D. in biochemistry, chemistry, biology pharmacy, or related pharmaceutical field. Minimum of 7 years experience in pharmaceutical product development with a minimum of 4 to 5 years in leadership CMC regulatory affairs and a strong biologics background. Medical Device and/or Combination Product experience desirable. Significant experience in directing interactions with regulatory authorities. Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development and maintenance.

    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.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=amRpZXR6LjY2MzcwLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t


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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
    Pfizer Hematology research is part of the Rare Disease Research Unit and focuses on developing new therapies in the field of Hemophilia, Hemostasis and other blood related conditions including Sickle Cell Disease and beta-Thalassemia. The RDRU is part of Pfizer's Biotherapeutics in Pfizer Worldwide R&D. Pfizer Hematology research applies a heavily externalized model; the team advances internal programs in a matrix environment and to a significant degree collaborates with external partners in academia, industry and at commercial service providers. The candidate will be responsible for delivering high quality data to the project team and presenting results project and team meetings.

    Responsibilities
    The ideal candidate will be a highly motivated, dynamic laboratory scientist and will have demonstrated experience and expertise with in vitro assays. The candidate is expected to contribute to and support project advancements in the Hematology Research group. Applicants must have experience in a wide range of assays. The work will involve the performance of assays, analyzing the results as well as assessing, and maintaining the reproducibility of the data generated. The candidate will work closely with other team members to deliver high quality data.

    Qualifications
    * B.Sc./M.Sc in Biomedical Sciences, Biochemistry, Biotechnology, Biology or related field and 1-5 years of experience working within a pharmaceutical setting.
    * Demonstrated skills in the implementation of in vitro assays.
    * Expertise in vitro assays, ELISA, qRT-PCR, molecular and cell biology (transfection, SDS-PAGE, Western blot analysis, immunoprecipitation) is desired.
    * Strong in vitro cell culture skills.
    * Excellent organizational, interpersonal, written, accurate data recording, and verbal communication skills.
    * Self-motivation and the ability to collaborate as part of internal and external cross-functional teams.

    PHYSICAL/MENTAL REQUIREMENTS:
    Standard lab physical requirements.

    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.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjAxNzYwLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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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
    Post-doctoral Research Fellow in Analytical and Bioprocess Research and Development - the successful candidate will be responsible for developing, optimizing and applying a variety of analytical methods designed to rapidly characterize N-linked oligosaccharide structures on test monoclonal antibodies and determine nucleotide sugar levels in cell culture samples. The candidate will also be responsible for employing cell and molecular biology techniques aimed at modulating N-linked oligosaccharide structures. The position is shared between the Analytical Research and Development and the Bioprocess Research and Development groups in the Biotherapeutics Pharmaceutical Sciences department. These groups are partnering in collaboration with an academic research lab in Cambridge, MA to understand the systems and synthetic biology concepts and tools required to control the N-glycan profile of monoclonal antibodies expressed in CHO production cells. The goal of the work is the
    development of methods in support of this collaboration. The candidate will be expected to evaluate existing methodology and then further develop, optimize and or apply as necessary to satisfy the analytical needs of the collaboration. The desired outcome is the publication of results in peer-reviewed journals and presentations at scientific conferences.

    Responsibilities
    The qualified candidate will be responsible for developing, optimizing and applying a variety of analytical methods designed to rapidly characterize N-linked oligosaccharide structures on test monoclonal antibodies and determine nucleotide sugar levels in cell culture samples. Thorough research of contemporary literature regarding high throughput analysis of N-linked glycans and nucleotide sugars and application/advancement of state of the art techniques documented within the literature is expected. The candidate will be expected to assist in applying learning from the analytical analysis by designing and executing experiments using cell culture models to modulate N-linked glycans. The candidate will also be expected to work with cell line development colleagues at Pfizer or in an academic lab to develop sample handling procedures designed to minimize sample handling artifacts and generate samples that are most representative of the cell’s metabolic state. The qualifi
    ed candidate will be expected to collaborate with multiple groups within Pfizer and with an external academic lab. The candidate will be expected to generate data and contribute to manuscripts for publication in peer-reviewed journals and to presentations at scientific conferences.

    Qualifications
    PhD in Chemistry, Biochemistry or related fields required. A strong background in N-linked glycan analysis and small molecule separations is required. This includes experience with high performance liquid chromatography and mass spectrometry at a minimum. Experience with high throughput analytics is desirable. A strong understanding of the glycosylation pathways in mammalian cell systems is required. A working knowledge of cell and molecular biology and cell culture techniques is desirable. Strong written and verbal communication skills are required. A strong history of publications in peer-reviewed journals and presentations at national conferences is desired.

    PHYSICAL/MENTAL REQUIREMENTS
    The position will require that the colleague perform routine lab tasks such as pipetting, standing or sitting at a lab bench for extended periods of time and walk up and down stairs in order to move from one lab to the next. The position will also require that the colleague perform complex data analysis and work at a computer for extended periods of time.

    NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
    The colleague will be expected to perform most of their work at the Andover facility but will also be expected to attend meetings in Cambridge at least twice a month. The colleague will be expected to present at external conferences, which may require travel.

    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.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=ZWRkeS5uaWNvbGFzLjI0OTI1LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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    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 successful candidate will be responsible for the execution of in vivo and in vitro studies to support the development of novel therapeutic agents for cardio-renal disease. This individual will be a key contributor to the cardiovascular group and utilize hands-on laboratory expertise to advance an innovative drug discovery portfolio. The successful candidate will thrive in a fast paced-and goal oriented, project team environment with unique opportunities for scientific and professional development.

    Responsibilities
    * Execute in vivo studies to assess the efficacy of therapeutic agents.
    * Support development of animal models of cardio/renal disease.
    * Ensure the timely implementation of in vitro and ex vivo studies to assess activity of novel compounds.
    * Participate in the development of novel in vitro assays as required by cardio/renal project needs.
    * Ensure all tasks and responsibilities are carried out according to scientific and ethical standards.

    Qualifications
    * BS/MS in biology, pharmacology or related field with 2+ years of laboratory experience
    * Strong expertise with general handling and dosing of rodents as well as other in vivo techniques is required; proficient at performing animal necropsies and harvesting of tissues including heart and kidney.
    * Hands-on experience in molecular biology techniques, including RT-PCR, western blotting and ELISA is required.
    * Excellent communication, presentation and writing skills; ability to multitask and troubleshoot.
    * Strong organizational skills and attention to detail in the conduct of hands-on experiments and generation of data.

    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.

    Please apply at: Application URL:http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjE0MjMxLjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ


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  • 11/03/15--23:49: Sr Software Engineer
  • A central challenge in genomics and medicine is to organize, analyze, and disseminate information derived from datasets that can characterize the genetic basis of disease. The rapidly growing type 2 diabetes (T2D) genetics knowledgebase and portal (www.type2diabetesgenetics.org) aim to aggregate and democratize these data to the broad biological community.

    We are supported by consortia for genetics research (the National Institutes of Health funded T2D-GENES project and the Carlos Slim Foundation funded SIGMA-T2D initiative) as well as by public-industry partnerships (the AMP-T2D project).

    A central challenge in this setting is to develop software to perform analyses and access results from genomic datasets that may be distributed in many locations around the world. We are searching for a candidate to (a) collaborate with scientists and engineers from around the world to develop standards for sharing and analyzing genomic data; (b) develop software to implement REST services supporting these standards and databases storing the underlying data; and (c) research and develop new software to perform efficient joint analyses of datasets distributed at multiple locations. Software engineering tasks will span API design, REST service implementation, use of relational or NoSQL databases to store data, and exploration of new technologies for multiparty computation such as Intel Reliance Point.

    The successful candidate will work closely with a small team (6-10 members) of engineers and computational biologists that employs aspects of the Agile software development process. He or she must also be able to interact comfortably in a scientific consortium setting. The working environment is that of a world-class scientific institution, where staff are devoted to the betterment of human health through the application of science. Applicants should be deeply motivated and passionate about the prospect of leveraging shared genomic data to improve care for T2D and other diseases.

    Characteristic Duties
    - Developing standards for sharing genomic data and analytical results
    - Writing and testing code
    - Exploring new software technologies for multiparty computation
    - Working with the scientists who provide data and analytical capabilities
    - Must have experience in Java.
    - Experience with relational or NoSQL databases is required
    - Experience with REST-based Web Services highly desirable
    -  Previous work on multiparty computation a huge plus
    - Experience using design patterns is desirable
    - Interest in biology, genetics, or drug discovery highly desirable but not required
    - Desire to learn new/emerging technologies, tools, and platforms is required
    - Excellent communication skills (written and spoken) are required
    - Passion for learning, problem-solving, and innovation is required
    - Willingness to work closely with other team members is required

    EOE/Minorities/Females/Protected Veterans/Disabilities

    To apply for this position, please CLICK HERE


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  • 11/03/15--23:55: Sr Systems Engineer
  • The Broad Institute is a collaborative research institute with a mission to propel the understanding and cure of disease. We made fundamental contributions to the human genome project, and are among the leading genomic science institutions in the world. Our technical problems are large and interesting. We generate hundreds of Terabytes of unique human genomic data per week. We serve a community of thousands of researchers who are quite literally working on understanding the causes and developing the cures for diseases like Autism, Diabetes, and Cancer. Our software is, in many cases, the gold standard used by the world bioinformatics community in analyzing genomic data of all sorts.

    The DevOps team exists within the Research Computing organization, which is approximately half of the IT department. This position is within DevOps, which serves both the software engineering / data sciences group and the IT organization’s own needs. The research computing organization manages dozens of petabytes of data storage, tens of thousands of cores of high performance linux server, and a hybrid cloud that leverages both Amazon and Google’s services.

    We are in the process of deploying a system for the National Cancer Institute that will serve cancer researchers worldwide. The ideal candidate will have a proven track record of designing, building, and sustaining operations on complex systems. They will be passionate to the point of fanaticism about automation and the fact that in the modern world, “infrastructure is code.” The ideal candidate will have built solutions that scaled rapidly to meet global needs, and will have the battle scars to prove that this is never as easy as it sounds.

    This candidate will have experience working with software engineering teams, and will understand the muddy reality of deploying and supporting platform as a service technologies at scale.

    Technical Competencies:
    - We are seeking an experienced doer of things, who has at least 5 years of experience in building cloud and virtualized solutions. Educational credentials and certifications are secondary to time in the technical trenches and proven success.

    Systems automation:
    - We use Puppet. Experience on Chef, Ansible or Cfengine are totally applicable.

    Systems Integration and APIs:
    - Useful services build on each other via APIs. The ideal candidate will have experience learning how to make use of the interfaces for public and private platforms to create useful, aggregate solutions.

    Monitoring and logging:
    - We use Splunk and Stackdriver. Experience with Pingdom or Loggly are totally applicable.

    Public Clouds:
    - We are heavy users of both Amazon and Google. Experience with at least one of those is required.

    Private Clouds:
    - We have substantial on-premise installations of both VMWare and OpenStack. Experience with OpenStack would be a strong advantage. VMWare experience is not essential.

    Operating Systems:
    - The candidate should be an experienced master of all things Linux. We use RedHat and Debian, but experience with other distributions applicable.

    Containerization:
    - Containerization is the way of the future. We use Docker and DockerHub. Experience with other frameworks is applicable, as well as container repositories and management frameworks such as Mesos and Kubernetes.

    Continuous Integration:
    - We need a person to own our CI environment from design through support. We use both Jenkins and Travis-CI.

    EOE/Minorities/Females/Protected Veterans/Disabilities

    To apply for this position, please CLICK HERE


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    The Broad Institute’s Klarman Cell Observatory (KCO) is a pilot effort to systematically define cellular circuits in mammalian cells, building on breakthrough technologies and collaborations across scientific disciplines. The Observatory develops and deploys experimental and computational approaches for systematically defining cellular circuits in health and disease. These include capabilities for measuring all cellular components and their connections, reconstructing circuit models with computational algorithms, and producing and delivering perturbing agents to cells.

    We are seeking a highly motivated individual to join our team of talented researchers in a highly collaborative research environment. This position offers an opportunity to work with state-of-the art genomic technologies (e.g. single-cell genomics) on a diverse set of project in the areas of immunology, neuroscience, and cancer research. In support of multiple projects, the successful candidate will be committed to systematically implement innovative research technologies in order to define cellular circuits.

    Specifically, they will:
    (i) process a variety of biological samples using several genomic methods; (ii) work to ensure sample preparation goals, timelines, documentation, and requirements are met; (iii) build systematic pipelines for technology implementation/deployment and process steps; (iv) improve existing protocols to generate robust standard operating procedures (SOPs); (v) investigate alternative solutions and troubleshoot processes as needed; and (vi) work to improve current workflow processes in creative and effective ways

    KEY RESPONSIBILITIES
    - Systematically process biological samples for multiple projects using cutting edge genomic technologies
    - Analyze experimental data and identify methodological problems/challenges. Adjust experimental protocols to ensure best outcomes and project completion in a timely manner
    - Work with supervisor to plan project requirements and timelines
    - Document, compile, and assist with interpreting experimental data. Report data to supervisor and team
    - Operate and maintains automated laboratory equipment to complete investigations
    - Attend team meetings to share results, plan projects and experiments, ensure that projects support current team goals in a dynamic environment
    - Consult with other senior scientists or scientific literature as needed
    - Help to train new lab members, students, interns, and collaborators
    - Prepare, order, and maintain stocks of necessary reagents, solutions and supplies

    REQUIRMENTS
    - BS degree in Biology or related field required
    - Must possess at least 1 - 2 years of experience in a research laboratory, preferably in an independent project
    - Must possess a familiarity with basic molecular biology techniques and sterile techniques
    - Familiarity with design of experiments and the scientific method required
    - Experience in a research laboratory and with standard lab equipment required; experience with automation preferred
    - Strong analytical skills, problem solving ability, and innovation aptitude required
    - Excellent computer skills required, basic programming skills and experience with databases preferred. Must be willing to discover and learn new software and technology applications quickly
    - Must have strong attention to detail and an ability to multi-task
    - Excellent written and oral communication skills, interpersonal skills and ability to effectively work as part of a team required
    - Excellent organization and time management skills
    - Ability to work independently with minimal supervision
    - Must thrive in fast-paced and dynamic environment

    The Broad Institute is redefining the boundaries of science and medicine with an interdisciplinary model designed to meet today’s most critical biomedical challenges. Here you will find a supportive and collaborative intellectual environment and a firm commitment to continuously invest in cutting edge technology. At the Broad we are developing the new tools that will enable scientists to begin unlocking the mysteries of genomics.

    BENEFITS
    - Colleagues who are intellectually curious, hard-working, and collaborative with backgrounds spanning science, journalism, policy and finance
    - Opportunities for professional development and career advancement
    - Frequent talks and events on science, art, law and policy
    - A generous benefits package
    - On-site yoga and boot camp classes
    - All the coffee and tea you can drinkThe 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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    Safety Partners’ Consulting Safety Officers provide hands-on EHS services to our established client base. If you love science but don’t want to be working “at the bench”, a great career alternative awaits you at Safety Partners, Inc.

    Our Consulting Safety Officers (CSOs) educate our clients on the regulatory and workplace safety requirements needed for their tailored EHS program. Developing and implementing customized programs in hazard communication, biosafety, chemical safety, emergency preparedness, and radiation safety allows our CSOs to interact with visionaries, researchers, and senior management at Massachusetts’ leading life science firms in a fast-paced, highly varied environment. 

    Specific responsibilities for our Consulting Safety Officers include, but are not limited to: 

    • Conducting Job Safety Analyses 
    • Developing and implementing policies and procedures for Biosafety, Chemical Safety, Radiation Safety, Emergency Preparedness, and the procurement, use & disposal of hazardous materials 
    • EHS permitting and licensing in compliance with Federal, State, and Local regulations 
    • Preparing and delivering training for Biosafety (rDNA, infectious materials, BBP), Chemical Hygiene and Hazard Communication, Radiation Safety, Laser Safety, Light Manufacturing, and more 
    • Auditing operations to confirm that EHS program components are being observed by client staff 
    • Coordinating and facilitating safety committees 

    Our successful client base has been established by over 20 years of dedicated work. Consulting Safety Officers are not responsible for sales, however all candidates must possess superior people and relationship development skills to interact with clients and regulatory agencies.

    Required Skills / Competencies:

    • 3+ years experience in a laboratory setting (biotechnology, pharmaceutical research, academic science, or medical technology science preferred) or EH&S related work experience
    • Strong, professional communication and written skills with staff of all levels
    • Superior soft skills; ability to negotiate and promote safety programs and services
    • Able to positively interact with regulatory agencies
    • Experience training groups of all sizes
    • Independent problem solving with little supervision
    • Strong organizational and prioritization skills
    • Be productive in a dynamic, fast paced consulting environment
    • Able to lift up to 50lbs
    • Proficient in the use of Microsoft Office Suite

    To Clients - Safety Partners is the leader in the field for workplace safety, providing custom EHS program development and implementation to over 300 life science and engineering companies in the greater Boston area. We are not a broker or an agency; we deliver high-quality, outsourced services to our clients.

    To Employees - Safety Partners provides an unusually flexible and supportive work environment. We offer both full- and part-time positions, and take great pride in working with individuals trying to balance the demands of working and raising a family. Our employees are genuinely nice people who are smart, detail oriented, articulate, and focused. Safety Partners offers a comprehensive benefits package including professional development, company paid short and long term disability, a simple IRA with company match, and a HSA & FSA. Health insurance is also offered to those working at least 28 hours per week.


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    Warp Drive Bio is driving the reemergence of natural products in the era of genomics to create breakthrough treatments that make an important difference in the lives of patients. Built upon the belief that nature is the world’s most powerful medicinal chemist, Warp Drive Bio is deploying a battery of state-of-the-art technologies to access powerful drugs that are now hidden within microbes. 

    Warp Drive Bio is seeking highly motivated and experienced “drug hunter” with a Ph.D. degree in organic chemistry to participate in fast paced medicinal chemistry programs to identify drug candidates for clinical development. The individual should possess strong core competencies in leadership, modern organic/medicinal chemistry techniques and drug discovery from hits to development candidates to IND filing. 

    Responsibilities

    • Lead chemistry discovery efforts for high profile drug targets with chemistry FTE at CROs and collaboration partners
    • Work independently and be able to effectively manage multiple priorities under time and resource pressures
    • Lead the design, plan and execute multi-step organic synthesis of high quality target molecules for biological screening
    • Prioritize the chemistry efforts to ensure timeline adherence and project alignment to meet group and company goals.
    • Assist in the planning and management of external research efforts with CROs and collaborations.
    • Interact with colleagues in structural biology, modeling, screening, biology and pharmacology and within chemistry department
    • Coordinate activities across functions to ensure successful delivery drug molecules at various discovery stage to IND filing 
    • Participate in core team meetings and in brainstorming and contribute new proposals and ideas
    • Preparation of patents, publications, and project planning

    Qualifications

    • A Ph.D. degree in organic chemistry with 10+ years of drug discovery experience in a pharmaceutical/biotechnology setting
    • Demonstrated leadership in medicinal chemistry and drug discovery as evidenced by a strong record of scientific accomplishment
    • An exceptional grasp of state of the art organic chemistry, be able to work on or experience with complex natural product molecules
    • Experience in structure-guided drug design, natural product-like library construction and an ability to analyze data critically
    • Good problem solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures
    • Excellent written and oral communication skills are required as is the desire and ability to work in a laboratory-focused and team environment
    • Experience functioning within a strong multi-disciplinary team and utilizing cross functional information

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    Flatley Discovery Lab, a not-for-profit Cystic Fibrosis research lab, has an opportunity for volunteers to join our growing team of scientists and researchers in Charlestown, MA. 

    We will consider candidates from recent graduates to retired professionals.

    Join Literature/Data Mining Researchers and become part of our team that searches for novel compounds from literature, subscriber tools, structural and computational protein modeling or just hunches. We welcome all scientific backgrounds and levels of education. This is an "Open Outcry" environment for trading ideas but also serious, and is designed to foster a creative learning environment.. All team members can choose their own compounds and receive feedback from our senior scientists and then have them made with the help of one of our chemists. You can then present your case to the group and then actually tested in our HTS, electrophysiology, and/or molecular biology lab. We currently have several compounds in development from Pre-Ind to a Phase 2 starting in Q1 2016.
    We are open 8am - 5PM, and you are allowed to make your own flexible times. We will pay for out of pocket traveling expenses within reason and we provide soda and snacks and sometimes pizza.

    If you feel you fit in, there are opportunities to be hired for a full time position as they become available. A description of some of the work we do and requirements are below. 

    Cell culture, high-throughput screening, protein purification, standard lab techniques, such as Western blots, PCR cloning, site directed mutagenesis, cell transfection, siRNA knockdowns and cell based assays, cell/molecular biology and protein biochemistry. Candidates must have a minimum of a BS in biology, or experience in related fields. Minimum 1 year experience preferred.


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  • 11/04/15--07:34: Process Engineer I
  • Process Engineer I 

     

    Hours Full Time

    Summary:
    As a member of the Manufacturing Science & Technology group, this individual will join a group of process scientists and engineers to support the process development and production of downstream processes for commercial productions.

    The scope of work will include designing studies under instruction, executing experiments and data analysis to support GMP investigations and manufacturing change controls and to reduce reoccurring deviations. The focus of the work will be downstream unit operations such as column chromatography, harvest clarification, TFF and normal flow filtration. This individual will interact with other PD groups and other departments including manufacturing, PTS, QC, QA and Engineering etc.


    Requirements
    Good knowledge in protein purification and characterization; DoE study, Proficiency in column chromatography, filtration and TFF; Proficiency in AKTA explorer and avant; Must be well-organized and self-motivated, and possess an independent work style; Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside Client.

    Needs someone that has protein purification experience necessary AKTA experience necessary UFDF experience necessary Downstream purification department Bachelor’s Degree Required 2-3 Experience (at least) needed within a pharma/bio company GMP experience NOT necessary


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  • 11/04/15--07:35: QA Manager
  • First Light Biosciences is developing breakthrough automated medical diagnostic products for rapid, sensitive, automated, and cost-effective detection of the microbes that cause hospital infections. The products address the key medical need to rapidly determine the right antibiotic to cure these life-threatening infections. Based on its proprietary MultiPath™ digital imaging technology, First Light’s products will combine the performance of the most advanced automated commercial laboratory tests with unprecedented affordability and ease-of-use.

    First Light Biosciences is a well-funded Bedford, MA company offering a stimulating environment with a culture of excellence in science, engineering, and business.

    The QA Documentation Manager will support the organization with compliance and conformance to the quality systems while implementing First Light’s powerful new technology.

    Responsibilities:

    • Maintain internal controls over quality policies, procedures, and specifications, ensuring effective versions of procedures are available to employees for implementation
    • Review all completed documentation and assure all documents are effectively routed for final review and approval
    • Facilitate changes to SOPs, policies, training materials, and other documents
    • Act as documentation coordinator for all aspects of documentation and change controls
    • Create/maintain procedures, policies and training documentation for the control and use of the systems and processes
    • Write/edit procedures in conjunction with technical subject matter experts in a collaborative manner
    • Review documents for grammar, accuracy and consistency with departmental guidelines
    • Conduct user training sessions for staff members
    • Administer the Corrective and Preventive Action system (CAPA)
    • Maintain data within the electronic QMS database, providing routine status reports and updates to current CAPA system activities and update quality/compliance trends or failures
    • Perform review of development batch records for completeness per the requirements and internal procedures
    • Support ISO 13485 and 21 CFR 820 compliance and inspection readiness within organization
    • Provide ongoing support and review of Quality System documents including Procedures, Work Instructions, Forms and design history file documents  and other applicable quality standards, regulations, corporate policies and guidelines
    • Perform Local Data coordinator duties with electronic QMS system, create and maintain master data for finished products
    • Assist during FDA and customer audits

    Qualifications:

    • BS in Scientific Discipline with minimum of two years of experience in Quality Assurance
    • Minimum of five years of experience working in an In Vitro Diagnostic or Medical Device company with a focus on ISO 13485 Quality Systems and/or 21 CFR 820; product development experience a plus
    • Demonstrated knowledge of Quality Assurance activities and ISO regulations as they relate to product development, manufacturing and technology transfer
    • First-hand experience in planning, writing and reviewing Standard Operating Procedures
    • Exceptional interpersonal, problem-solving, and written/verbal communication skills

    Position type: Full-time

    Competitive salary and benefits. Title and compensation depend on experience and education.

    Please apply by email only to jobs@firstlightbio.com. To ensure proper processing include the Job Code QAMNOV15MBC in the subject line of the email.


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    Opportunity:

    New position in company with double digit growth and aggressive growth plans.

    **Ideal Home base in Northeast US, preferably Boston, NYC, Philadelphia, or NJ**

    THIS IS PRIMARILY AN INSIDE SALES ROLE

    Scope:

    Initial point of contact for pre-sales customer inquiries and outbound prospecting. Manages the sales process for specific products lines, accounts and/or sales opportunities via phone and e-mail. Includes engaging with existing customers and generates sales leads, introducing customers to the NanoString products that best meet their needs, coordinating with internal resources to address customer questions/objections, providing pricing, creating and submitting individualized quotes, negotiation and coordinating with manufacturing to ensure delivery of products and closing the sales process through the point of order receipt. Works closely with Regional Account Managers to meet and exceed sales quotas for a specific the territory.

    Responsibilities:

    • Support Regional Account Managers with lead generation, customer follow-up & seminar marketing
    • Initial point of contact for pre-sales customer inquiries and outbound prospecting.
    • Includes engaging with existing customers and generating sales leads
    • Managing Trade Show leads and their respective qualifications
    • Ensure compliance with manufacturing protocols to ensure product build and shipment
    • Establishing new customers and maintaining/growing existing customer accounts
    • Establish and nurture positive, productive relationships with customer accounts including product end-users, management and purchasing contacts.
    • Work collaboratively with Marketing to drive product promotions and provide feedback on ROI
    • Maintaining and assigning leads, sales opportunity and customer intelligence data into CRM database

    Preferred Educational Background:

    • Bachelor’s degree in a science or technical field required. Genetics, molecular biology, chemistry strongly preferred.
    • M.S. degree in molecular biology or a related field a strong plus.

    Preferred Experiential Background:

    • 2-4 years successful sales experience with a technical product line preferred.
    • Solid fundamental understanding of genetics.
    • Demonstrated ability to quickly grasp and master highly technical concepts and articulate them well to others.
    • Genetic sales, customer service or technical support experience preferred.
    • Outstanding listening, verbal and written communication skills.
    • Strong interpersonal skills with the ability to communicate effectively with a wide range of customer personality types. Ability to work well with highly educated research scientist customers.
    • Strong ability to identify customer needs, obstacles to the sales process and solutions using NanoString products.
    • Proficient with Microsoft Office (Outlook, Excel, Word, PowerPoint)
    • Experience working with Microsoft Dynamics or a similar CRM database a plus.
    • Strong business sense, instinct and personal drive.
    • Team goal oriented with a focus on achieving team sales performance metrics through personal contribution and teamwork.

    Please apply here: https://nanostringtrial.applytojob.com/apply/HW1f7H/Inside-Sales-Consumableslife-Sciences-North-East.html?source=MA+Biotech+Council 


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    DIRECTOR / SENIOR DIRECTOR, SCIENTIFIC LIAISON                                    

     

    Company

    Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB) is a clinical-stage company focused on the discovery, development and commercialization of novel therapeutics based on our proprietary Safely Metabolized And Rationally Targeted (SMART) linker technology platform. Our SMART linker technology platform aims to treat diseases by simultaneously modulating multiple targets in disease pathways. Our product candidates are designed for enhanced efficacy and improved safety and tolerability. Our focus is on treatments for rare diseases. We are also developing other product candidates for the treatment of serious lipid disorders. Our two clinical programs, CAT-1004 and CAT-2054, have the potential to disrupt treatment paradigms. CAT-1004 is an oral NF-ḲB modulator for Duchenne muscular dystrophy (DMD), with the potential to be a disease-modifying agent broadly applicable across age groups and mutations. CAT-1004 in DMD has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA. CAT-2054 is an oral Sterol Regulatory Element-Binding Protein (SREBP) modulator for hypercholesterolemia. Catabasis is building a team of highly motivated and experienced professionals who are committed to achieving its mission of bringing hope and life-changing therapies to patients. For more information please visit www.catabasis.com.

     

    Responsibilities

     

    The Director / Senior Director, Scientific Liaison will play a critical role in effectively maximizing the value of our technology platform and pipeline assets through compelling scientific communications and strong relationships with key opinion leaders, advocacy organizations, and as appropriate, patients and parents. Working closely with the research and clinical teams, he / she will define and execute the scientific communication and thought leader development strategy, with a focus on making Catabasis a recognized leader in the disease areas of interest.

     

    Specifically, the Director / Senior Director, Scientific Liaison will:

    • Identify, tier, and develop strong relationships with key opinion leaders
    • Identify, tier, and develop strong relationships with advocacy organizations
    • Put together a compelling scientific story to support the Company’s corporate communication and investor relations strategy as well as the Company’s business development strategy
    • Develop and execute a plan to solicit scientific advice for product candidates, via advisory boards, 1:1 discussions with subject matter experts, and professional and patient organizations
    • Develop and execute a grant sourcing strategy via advocacy organizations, government agencies, and other non-profit organizations
    • Design and execute a robust scientific data generation and dissemination plan via scientific conferences and publications
    • Be the go-to person in the Company for scientific information, including competitive and landscape analyses of scientific data, answers to question from investors, business development due diligence, and corporate presentations
    • Work closely with the Clinical group to represent the Company at key patient and scientific venues to ensure understanding of clinical trials and support patient enrollment, including interactions with parents and patients as appropriate

     

    Qualifications

     The ideal candidate will have a strong track record of success in building compelling scientific cases and strong relationships with key opinion leaders and advocacy organization. At least five years of experience in biopharma in some or all of these areas is a must, and experience in rare diseases is a strong plus. Requires travel 10 – 25% of the time, including domestic and international.

     

    The candidate must be a strong leader and a natural relationship-builder. He / she will be a self-starter and work effectively both independently as well as collaboratively in cross-functional group settings. The Director / Senior Director, Scientific Liaison must possess keen scientific acumen and a knack for business needs. The role requires strategic thinking as well as a desire to get things done and make a meaningful difference. The successful candidate will have excellent writing and PowerPoint skills, and be a strong presenter.

     

    The ideal candidate will have an advanced science degree such as an MS, PhD, PharmD.


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    Analytical Associate Scientist

     

    Company Description

    Catabasis Pharmaceuticals (NASDAQ CATB) is a clinical-stage biopharmaceutical company based in Cambridge, MA.  Catabasis is focused on the discovery, development and commercialization of novel therapeutics based on its proprietary Safely Metabolized And Rationally Targeted, or SMART, linker technology platform.  Catabasis’ initial focus is on treatments for rare diseases, though it is also developing product candidates for the treatment of serious lipid disorders.  Catabasis is assembling a team of highly motivated and experienced professionals who are committed to improving the lives of patients and building a world class biotechnology company. Catabasis’ lead asset, CAT-1004, received Fast Track designation from the FDA for the treatment of Duchenne muscular dystrophy (DMD) in July 2015.

     

    Position Description

    We are currently looking for a highly motivated, energetic, and resourceful individual to join our team as an Analytical Associate Scientist.  This candidate will have a supportive role in Analytical Development by performing routine and complex HPLC-MS and GC techniques associated with non-GMP in-house stability studies, material release, in-process testing, formulation preparation and assessment and statistical analysis of results.  A successful candidate will also contribute to method development by investigating and troubleshooting assays and equipment issues and recommending method improvements.

     

    Requirements

    • BS in Analytical Sciences or a closely related field and 2-5+ years of industry experience in analytical development and/or quality control, preferably with a small molecule background.
    • Experience with HPLC-MS, GC, wet chemistry techniques.
    • Familiarity with USP and global compendial methods and cGMPs.
    • Experience with Agilent systems and software and MS Office software.
    • Able to work independently with minimal supervision and direction.
    • Possess excellent communication skills (written and oral) and a desire to contribute broadly.
    • Proven ability to thrive in a cross-functional and collaborative atmosphere.
    • Ability to succeed and develop in a dynamic biotechnology start up environment and to perform tasks with a sense of urgency.

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  • 11/04/15--08:43: Part-Time Technical Writer
  • The Marketing Communications Department at New England Biolabs is currently seeking a part-time Technical Writer, approximately 28 hours per week.  Primary responsibilities include writing editing and critically proofreading scientific marketing material, including product manuals, data cards, application notes, brochures and web-based communications.  

    Primary Responsibilities: 

    • Clearly and concisely document scientific information into easily understandable language.
    • Write and edit marketing publications and scientific reference materials.
    • Revise and proofread marketing collateral, including flyers, brochures, newsletters, application notes and the company website.
    • Proofread web content for accuracy and provide updates to technical pages, both in print and online.
    • Write content for posting on social media.
    • Assist in storyboarding and scriptwriting for videos and animations.

    Qualifications and Experience: 

    • Bachelor’s degree in Life Sciences required; master’s preferred.
    • 3 -5 years’ technical writing experience, ideally including the preparation of commercial materials.
    • Attention to detail and quality.
    • Ability to function independently and as a team member, in a fast-paced environment.
    • Excellent grammatical, writing and editorial skills.
    • Good communication skills, being able to articulate changes needed for various materials being worked on.
    • Proficient in Microsoft Office; In Design experience is a plus.
    • Experience with databases and Content Management Systems also a benefit.

    New England Biolabs is an Equal Opportunity/ Affirmative Action Employer of Minorities, Females, Disabled and Protected Veterans

     Candidates may apply online at www.neb.com or by accessing the following link: Part-Time Technical Writer


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    The Company:

    Flexion Therapeutics (NASDAQ: FLXN) is a specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapies.

    The company’s lead program, FX006, is an intra-articular sustained release steroid injectable in Phase 3 development for patients with moderate to severe osteoarthritis (OA) pain. We also have two additional product candidates: FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.

    The Role:

    Reporting to the Vice President, Clinical Operations, the Manager, Clinical Data Management works with clinical, biostatistics, and contract research organizations (CROs) to ensure that data management activities are performed with quality according to project timelines.  This position will manage all data management activities from CRF design through database lock for in-house and outsourced clinical trials with minimal supervision.

    Responsibilities:

    • Works with clinical, biostatistics, and CROs to design and develop study documents including Case Report Forms (CRFs), CRF Completion Instructions, Data Management Plan (DMP), Database Specifications, Electronic Edit Checks, and Data Transfer Specifications in CDISC format
    • Manages the CROs to ensure that outsourced data management tasks remain on target according to project timelines and within budget
    • Manages third party vendors including review of data transfer specifications, managing data deliverables, reconciliation and ensuring quality transfers on time and within budget
    • Proactively organizes ongoing data review within clinical and biostatistics throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies
    • Oversee and perform, as necessary, the following tasks:
      • Lead data management contact for a program
      • Drive study setup, maintenance and lock activities
      • Plan and perform user acceptance testing of clinical database (CRF and edit checks)
      • Generate, review and approve data management plans
      • Review and approve data transfers and other deliverables from external sources
      • Lead cross-functional discussions to define data handling and database design standards
      • Define and manage timelines to meet deliverables on time and with quality
      • Generate and disseminate project status reports to management
      • Manage CRO/data management specific vendor activities, timelines, and budgets
    • Participate in data management initiatives such as evaluate technology vendors (i.e. EDC, analytic tools), author and review SOPs, and establish data collection and reporting standards

    Requirements: 

    • Knowledge of the clinical trial process, ICH GCP, and applicable health authority regulations
    • Experience with Medidata RAVE, SAS and Coding tools
    • Awareness and familiarity of statistical methodology
    • Ability to solve complex problems in all areas of data management
    • Effective communication skills, both verbal and written
    • Strong attention to detail
    • Ability to work independently with minimal supervision and excellent written and oral communication skills are required

    Education:

    • Bachelor’s degree required with a minimum of 5 years of relevant work experience in clinical data management in the pharmaceutical/biotechnology industry

    To apply for this position, please submit a resume to work@flexiontherapeutics.com


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  • 11/04/15--08:54: Data & Analytics Lead
  • CLIENT: Biotech Company

    COMPENSATION: $$$

    The Clinical Data Sciences (CDS) department is strategically focused on clinical data, optimizing the data flow from CRF to Submission including but not limited to Data Management and Statistical Programming. The four areas of focus for CDS include Data Planning, Data Operations, Data and Analysis Infrastructure and Quality and Process Management. The Data and Analytics Lead (DAL) role is part of the Data Operations group. This role has a focus on Early Clinical Development, include pre-clinical, Phase 0 and Phase 1 studies. 

    The Data and Analytics Lead manages the end to end clinical data flow (data acquisition from Case Report Form (CRF) to Clinical Study Reporting (CSR) to Electronic Submission (ESUB) of Clinical Data) and ensures timely project execution; recognized as an operational specialist in data flow and study execution by all functions across Development Sciences. Partners with CDS Data Strategy Lead and key study team members to facilitate implementation of a robust and clear Data Strategy for assigned studies. Uses phase, TA and operational knowledge to establish study level operational plans and oversees CROs and other vendors to ensure timely execution. Develops study level quality plans and ensures adherence and consistent execution across the data flow. Collaborates with Program DALs to ensure alignment of study operational plans with program goals and for execution and quality. 

    Develops timeline and project manages all end to end data and statistical programming and submission deliverables in collaboration with cross functional team members and vendors. 

    Oversees execution of data management and statistical programming/electronic submissions deliverables. Interprets and applies data strategy, verifies consistency and usage of data, results and submissions standards, Coordinates and oversees outsourced personnel, and monitors and reports on overall study/program progress. Accountable for overall quality of study data. 

    Develops risk mitigation or action plans and oversees execution when appropriate. 
    Primary contact between CDS and clinical study management teams (SMT and/or Clinical Development Team representatives). Liaises directly with internal customers (CDS functions, GCO, Biostatistics, Regulatory Affairs) and external customers (Full Service and Functional Service Provider Data Leads and Project Management personnel) 
    Serves as Subject Matter Expert for data, reporting, and analysis process definition, improvement, and innovation as needed. 
    Manages performance and quality issues with vendors and escalates to vendor managers and Management and develops appropriate risk mitigation as needed. 
    Support study-level audit and inspection readiness activities as needed. 
    Serve as project manager on special projects and initiatives; partners with Statistical Programming, Vendor Management and Quality depending on type of project. 

     

    • 8+ years relevant work experience with a focus on data management and/or data analysis 
    • Deep understanding of drug development and biopharmaceutical industry required 
    • Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable 
    • High attention to detail including proven ability to manage multiple, competing priorities 
    • Experience overseeing outsourced clinical trials work 
    • Demonstrated ability to establish effective business relationships with external stakeholders, including implementing process change at a vendor 
    • Deep knowledge of clinical data management and statistical programming outsourcing with full-service, global CROs and FSPs 
    • Demonstrated ability to influence without authority 
    • Excellent written and oral communication skills

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