Articles on this Page
- 10/22/15--07:58: _Clinical Sample Ope...
- 10/22/15--08:19: _Research Assosciate...
- 10/22/15--08:34: _Image Analysis Deve...
- 10/22/15--09:04: _Director, Drug Prod...
- 10/22/15--09:04: _Senior Medical Writer
- 10/22/15--09:12: _Sr. Manager, CMC Do...
- 10/22/15--09:13: _Copywriter (Contract)
- 10/22/15--09:14: _Director, Regulator...
- 10/22/15--09:14: _Research Associate,...
- 10/22/15--09:22: _Associate Director,...
- 10/22/15--09:30: _Scientist, Purifica...
- 10/22/15--09:33: _Senior Scientist, C...
- 10/21/15--22:05: _Manufacturing Suppo...
- 10/21/15--22:42: _Multiple postdoctor...
- 10/21/15--22:47: _Postdoctoral Positi...
- 10/21/15--22:53: _Postdoctoral positi...
- 10/21/15--22:56: _Protein Biochemist ...
- 10/21/15--22:58: _Research Assistant I
- 10/21/15--22:59: _Associate Scientist
- 10/22/15--00:23: _Director, Clinical ...
- 10/22/15--07:58: Clinical Sample Operations Manager
- Plans and coordinates all operational activities required for the collection, delivery and testing of clinical biomarker or diagnostic samples within a clinical study.
- Works closely with Scientists to execute exploratory and Companion Diagnostic biomarker strategy.
- Creates synergies across studies within each project by providing oversight throughout biomarker operations.
- Aligns processes surrounding vendor selection and management
- Develops project specific tools and documents to streamline activities
- Acts as the primary point of escalation for issue resolutions
- Evaluates resourcing needs
- Supports recruitment of new personnel
- Responsible for the development and implementation of the clinical biomarker operations strategy, including CRO management, lab manual generation, sample collection and shipping logistics, and budget, etc.
- Provides input on Protocol and ICF development
- Identifies novel and innovative clinical sample collection and processing techniques and ensures logistical feasibility
- Manages timelines for sample testing and data transfer with both internal testing labs and external vendors
- Single point of contact for status of clinical trial samples and biomarker data
- Manage sample transfer/discrepancy resolution with Central Lab and other sample analysis/storage CROs
- Provide sample and assay status updates
- M.Sc. or higher degree with 3 to 5 years of industry experience is required
- Biological laboratory experience with evidence of involvement in the processing and analysis of biological samples is strongly preferred
- Familiar with technologies used in clinical sample analysis, including but not limited to protein, DNA and RNA analysis
- Prior experience in clinical sample operations is preferred
- Detail oriented with the ability to work independently and manage multiple projects simultaneously
- Excellent verbal, written and presentation skills
- Proven ability to work successfully under pressure
- Ability to work in a multifunctional team environment, interact with a wide variety of internal and external customers and relate effectively to people at all levels of the organization
- 10/22/15--08:19: Research Assosciate, PBMC
- BS/MS in life sciences, biochemistry, pharmaceutical or related sciences
- 1 to 2 years experience in industry or strong academic based research
- Good cell culture skills and aseptic technique
- Working knowledge of Flow Cytometry is needed
- Familiarity with PBMC isolation as well as FACS, ELISA, and immunoblotting is preferred
- Must be willing to have a flexible schedule (some days 9-5 and some days 11-7)
- Desire to cure Parkinson’s Disease!
- 10/22/15--08:34: Image Analysis Developer-Registration & Segmentation
- Develop image analysis methodology from concept through to validation and application in close cooperation with our research-driven customers.
- Create new tools and extend pre-existing tools for image registration and segmentation of 2D and, particularly, 3D medical image data.
- Transition image analysis tools and methods from prototype to deployment, including integration into established software platforms and dissemination to colleagues and customers successfully.
- Manage customer-specific analysis projects, including generation of appropriate inviCRO-standard supplemental materials (QC, plots, reports, spreadsheets) in parallel with project-specific analysis output.
- Oversee an image analysis team to achieve short-term and long-term image analysis goals.
- PhD or Masters with 2 or more years of relevant experience in image science, computer science, or electrical engineering with an image processing focus, particularly for image registration and segmentation
- Knowledge of imaging modalities, primarily SPECT and PET with some experience with CT, and/or MRI and data formats, particularly DICOM
- Strong analytical skills and ability to balance attention to detail while working to deadlines
- Ability to multitask and work to deadlines in an environment of change
- Ability to learn quickly on the job through mentoring and action
- Self-motivated and resourceful with good interpersonal skills
- Ability to independently manage workflow to see projects through from start to completion
- Strong programming, image processing, and signal processing skills are critical requirements
- 10/22/15--09:04: Director, Drug Product Development and Manufacturing
- Demonstrated leadership and management skills
- Experience in drug substance and drug product protein formulation, including lyophilization
- Experience in cGMP, aseptic manufacturing of parenteral drug products is a plus.
- Experience in technology transfer and management of contract manufacturers is a plus.
- Strong understanding of drug delivery options
- Excellent communication skills including the ability to write technical reports and CMC sections for regulatory submissions
- Ability to work in a fast-paced, dynamic, environment.
- Ability to travel internationally.
- Ph.D. in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years experience in a development environment.
- 10/22/15--09:04: Senior Medical Writer
- 10/22/15--09:12: Sr. Manager, CMC Documentation
- Write, review, and edit CMC regulatory documents across multiple programs
- Integrate information from in-house Technical Reports into regulatory filings
- Work with Analytical Development personnel on data presentation and analysis
- Work with other Pharmaceutical Sciences personnel on appropriate CMC sections
- BS/MS degree Biochemistry or Chemistry, Biology or similar with 8+ years associated industry experience
- Previous experience writing biologics CMC sections of regulatory filings
- Previous experience in biologics development
- Ph.D. degree Biochemistry or Chemistry, Biology or similar with 5 years+ associated industry experience
- Experience with the preparation of CMC regulatory documents
- Excellent writing skills
- Working knowledge and experience in at least one CMC area such as drug substance or drug product process development, analytical development, manufacturing or quality with an understanding of the other CMC areas
- Experience with biologics; previous experience with biosimilars a plus
- Demonstrated organizational skills, ability to work across multiple projects
- Excellent communication and interpersonal skills
- 10/22/15--09:13: Copywriter (Contract)
- Communicate complex scientific and clinical data in a clear, concise, and compelling manner.
- Partner with internal marketers and stakeholders to deliver creative concepts and messaging that persuasively convey Foundation Medicine’ value proposition and achieves marketing objectives.
- Deliver strategic messaging content that demonstrates keen understanding of customer segments, go-to-market strategies, unique selling proposition, customer research and competitive landscape.
- Organize, prioritize and multi-task a variety of writing and proofreading assignments.
- Participate in creative brainstorming sessions to develop ideas for campaign concepts, visuals, copy and videos.
- Leverage best practices for effective concept and messaging development and measurement.
- Ensure excellence in messaging consistency and execution by meticulous proofing of own content
- Partner with internal and external stakeholders to develop campaign concepts, pitch, and pulling it through the various tactics.
- Life sciences, medical, diagnostics, pharma, or healthcare industry required
- Minimum of 5 years copywriting and campaign development experience
- B-to-C brand experience working on integrated campaigns and launches
- Experienced using creative briefs, persona driven content strategy, competitive analysis, positioning and message maps.
- Demonstrated multi-channel campaign work.
- Portfolio must be submitted with resume for consideration.
- Ability to clearly communicate creative direction to others.
- Adept at working within and developing messaging standards.
- Accustomed to meeting deadlines in a fast-paced environment.
- Acute attention to detail in all aspects of work.
- Strong written and oral presentation skills
- MS Word, Excel, and PowerPoint proficient.
- MS or PhD in life sciences preferred
- 10/22/15--09:14: Director, Regulatory Affairs, Consent Decree and Compliance
- Actively monitor progress on numbered steps against milestone dates and inform management
- Identify potential issues, propose remediation
- Compile and submit workplan amendments
- Coordinate Notifications and meetings with FDA NEDO related to CD
- Send out queries to CDMO/ALF for updated information
- Prepare and submit the periodic update document to the appropriate HA
- Member of Consent Decree Steering Committee
- Member of Consent Decree Governance Committee
Direct DCP program (Lead / Manage as needed)
- Manage DCP schedule and timelines
- Schedule and facilitate product kick-off meetings and steering committee meetings
- Conduct Comparative Analysis Reviews per protocols
- Develop Corrective Action Plans (CAP) where needed
- Write Interim and Final Report for each product
- 10/22/15--09:14: Research Associate, Cell Culture Development
- Assist in planning and designing experiments for the development, optimization and characterization of mammalian cell culture manufacturing process.
- Execute experiments and collect experimental data
- Analyze experimental data and interpret experimental results
- Write technical reports
- Solid knowledge in biological science and/or engineering principles is required.
- Hands-on experience in mammalian cell culture bioreactor process development is highly preferred.
- Familiarity with technical transfer is a plus.
- Must be highly motivated and be able to work as part of a multi-disciplinary team and committed to high quality work.
- BS or equivalent in a scientific discipline (Chemical Engineering, Biochemical Engineering, Biology or related field) with 2-5 years or MS with 0-2 years of relevant experience in the pharmaceutical /biotechnology industries.
- 10/22/15--09:22: Associate Director, Drug Product Development and Manufacturing
- Demonstrated technical project leadership skills
- Experience in drug substance and drug product process development and characterization; lyophilization experience is a plus
- Experience in cGMP, aseptic manufacturing of parenteral drug products.
- Experience in technology transfer and management of contract manufacturers is a plus.
- Strong understanding of drug delivery options
- Excellent communication skills including the ability to write technical reports and CMC sections for regulatory submissions
- Ability to work in a fast-paced, dynamic, environment.
- Ability to travel both domestically & internationally 25%+
- M.S. or Ph.D. in a scientific discipline (pharmaceutical science, chemical engineering, or life science) and a minimum of 8 years experience in a development environment.
- 10/22/15--09:30: Scientist, Purification Development and Manufacturing
- Develop and optimize protein purification process of biosimilars and innovative biologics to have desirable product quality attributes.
- Tech transfer and scale-up protein purification process to CMO facilities and support GMP manufacturing
- Qualify scale-up/scale-down models to facilitate process characterization.
- Design and execute bench-scale experiments. Develop new technologies. Write and review technical reports.
- Work closely with internal and external collaborators to ensure that corporate objectives are met.
- Solid knowledge and hands-on working experience of protein purification process development in an academia/industrial setting are required.
- Direct experience in chromatography and analytical biochemistry is a necessity.
- Knowledge and experience with statistical design of experiments and statistical data analysis are highly preferred.
- Must be highly motivated, have excellent organizational and communication skills. Must be able to travel internationally.
- Ph.D. in a scientific discipline (Biochemistry, Chem/Biochemical Engineering, or related field) with 2-5 years or MS with 8+ years of relevant experience in the pharmaceutical /biotechnology industries or academic setting.
- 10/22/15--09:33: Senior Scientist, Cell Culture Development and Manufacturing
- Lead effort in technology transfer of cell culture manufacturing processes to CMO facilities.
- Work collaboratively with CMOs in transferring and scaling-up cell culture manufacturing process and reviewing manufacturing batch records.
- As the person in plant, provide technical support for the troubleshooting of cell culture manufacturing and scale-up issues as well as the implementation of process changes. Tracking the progress of tech transfer and GMP manufacturing. Assist in closing deviations.
- Perform statistical data analysis and trending
- Ensure tech reports are completed in a timely fashion.
- Hands-on working experience in tech transfer of cell culture manufacturing process and on-site GMP manufacturing support is required.
- Direct experience with statistical data analysis and trending is a necessity.
- Experience in the design, optimization and scale-up of mammalian cell culture processes is a plus.
- Experience with regulatory filings and documentation is desirable.
- Must be able to travel internationally.
- Must have excellent organizational and communication skills. Must be able to work independently and as part of a multi-disciplinary team and committed to high quality work.
- Ph.D. in a scientific discipline (Chemical Engineering, Biochemical Engineering, Biology or related field) with 5-8 years or MS with 8+ years of relevant experience in the pharmaceutical /biotechnology industries in technology transfer, process scale-up and GMP manufacturing support.
- 10/21/15--22:05: Manufacturing Support Supervisor
- Select, develop and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
- Provide career development and guidance to direct reports. Identify training requirements/needs, develops OJT, and job related qualifications.
- Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
- Coach and mentor staff in all aspects of their job performance and career development; including training, feedback, rewards and disciplinary action.
- Develop work plans, assign tasks, and supervise team(s).
- Ensure staff has appropriate knowledge of department processes and procedures.
- Provide input into the department budget.
- Reconcile and approve time detail for employees in the time system, partner with manager to keep OT expenditures within budget.
- Establish and report applicable department or organizational metrics.
- Accountable for project completions and achievement of compliance goals.
- Represent department in project team meetings.
- Interact with project teams and cross-functional groups.
- Address and/or escalate site compliance problems and issues.
- Lead and facilitate meetings/workshops.
- Supervise Leads, Material Handlers, Couriers and Manufacturing Support staff in the Distribution/Support environment.
- Participate in the development of Distribution, Manufacturing Support and Logistics policies (including operational, safety and quality programs).
- Actively oversee daily inventory activities to ensure compliance with all company and regulatory agency policies and procedures.
- Ensure compliance with appropriate internal and regulatory policies and procedures. This includes product documentation, specifications, SOPs, FDA and other foreign authority regulatory requirements.
- Ensure execution of material flow, work practices and inventory control are in accordance with cGXP, FDA, OSHA, IATA, DOT, TSA and other applicable regulations.
- Responsible for keeping department in audit ready condition at all times.
- Manager supplier/vendor relationships (if applicable).
- Organize the staff and workload to meet or exceed productivity performance standards for designated area - inbound (receiving); production support; put away, storing packing and shipping of materials and/or finished goods.
- Listen and evaluate ideas to ensure the effective distribution of materials, inventory control and security for an assigned site.
- Complete corrective action plans to address deficient areas identified and to ensure adherence to compliance.
- Recommend and develop ideas for improvement in operating methods and procedures to resolve problems prior to or when they arise.
- Ensure that committed orders ship on time and those carriers comply with scheduled pick-up commitments.
- Be available on-call.
- High School diploma or equivalent and 3-5 years of progressive supervisory experience in high volume and fast-paced distribution center environment, supervising multiple functions within the distribution center, including but not limited to, inbound (receiving); inventory control;production support; put away, storing, packing and shipping of materials and/or finished goods.
- Must possess strong working knowledge of MS Office (Word/Excel/PowerPoint/etc).
- Bachelor's Degree or equivalent in Business Administration, Supply Chain or a related field or equivalent combination of experience and education.
- 3-5 years supervisory experience in a bio/pharmaceutical or medical device distribution center environment with cGXP requirements.
- Lean/Six Sigma experience.
- 10/21/15--22:47: Postdoctoral Positions in the Lab of Peter Kharchenko
- 10/21/15--22:53: Postdoctoral positions in the Lab of Griffin Weber
- Statistical modeling of scientific workforce
- Probabilistic algorithms and software for biomedical big data
- 10/21/15--22:56: Protein Biochemist (6 month temp position)
- Work independently and collaboratively within a multidisciplinary team with core competencies in bacterial protein production, purification, bioconjugation, flow cytometry, and immuno-oncology.
- Assist in the design, characterization, and optimization of proteins and protein scaffolds for key programs using antibody fragments and fusion constructs specifically tailored for oncology imaging applications.
- Perform protein stability, biochemical activity, and antibody affinity assays.
- Contribute to the optimization of key parameters for protein expression, purification, stability, efficacy, immunogenicity, etc. within the organization and provide support to multiple projects.
- Communicate research and development findings internally and contribute to scientific and strategy discussions to advance and enhance the scientific platform and product candidates.
- Contribute to external research efforts with contract research organizations.
- Maintain accountability for project success and results delivery
- Ph.D. or experienced M.A. in biochemistry, molecular biology, immunology, biotechnology or biomedical engineering with 2+ years of postdoctoral research, and/or 2+ years industrial experience.
- A strong understanding of protein engineering, enzymology, and immunobiology with expert knowledge in protein characterization assays.
- Proficiency in current molecular biology techniques, standard protein production and purification protocols particularly in prokaryotic systems, with a track record of antibody screening, and characterization in a pharmaceutical or biotechnology setting.
- Outcome-oriented with attention to details, effective organizational skills and the ability to interface constructively with other members of the R&D team, external partners, to drive multiple projects and timelines within a rapidly changing start-up environment.
- Expertise in synthetic organic chemistry is considered a plus.
- 10/21/15--22:58: Research Assistant I
- Performing a variety of routine laboratory tests and procedures, utilizing standard laboratory equipment, recording and checking results for completeness and accuracy.
- Maintaining records of results and methodologies in a log of work performed, as well as maintaining equipment, lab area and supplies in a neat professional manner.
- Assisting in the use of specialized laboratory equipment and analysis of data generated by this equipment.
- Carrying out all laboratory activities in compliance with applicable regulations and protocols.
- Conducting literature searches and reviews, compiling information for journals and suggesting uses for new techniques to the P.I.
- Bachelor's degree in Biology or Chemistry or a closely related health field and some lab experience
- Analytical skills to resolve problems that require the use of basic scientific, mathematical, or technical principles.
- Ability to exchange information on factual matters, schedule appointments, greets visitors, explain hospital policies, and/or relay messages to appropriate personnel. This type of interaction requires courtesy and tact when dealing with patients, visitors and/or hospital employees.
- 10/21/15--22:59: Associate Scientist
- 10/22/15--00:23: Director, Clinical Operations
- Lead and manage integrations of all project team activities; leveraging internal resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.
- Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for specified studies.
- Manage all aspects of CRO/vendor identification, request for proposal submission, CRO selection, and the day to day operational activities. Leverage resources, expertise, and knowledge within the CRO/vendor for smooth study execution.
- Plan and manage study operations including: study sites and tracking systems for regulatory submissions, CRO monitor visit reports and site correspondence, drug supply and use, enrollment of subjects, regulatory document flow including informed consents (and translations), study timelines, all budgetary and financial information, Pharmacovigilance/Serious Adverse Events, performance metrics, data flow, etc.
- Participate in Case Report Form and/or eDC specification design and user acceptance testing, data management plan review, and data quality review and tracking.
- Effectively communicate and interact with Key Opinion Leaders.
- Lead the development of contingency/risk management plans for projects and assist VP of Clinical Development Operations in the preparation and execution of sound development strategies.
- Budgets, timelines, and forecasts preparation for clinical studies.
- Interface with development project teams, and the legal and finance departments for planning, execution and tracking of Clinical Trials. Provide a variance analysis of budget to actual and notify Project Management and Finance of projected cost over/under expenditure.
- Participate in development and review of Clinical Development Operations processes, systems and initiatives.
- Ability to travel (no more than annual average of 20%).
- Bachelor's Degree is required.
- 10+ years of experience with a Biotechnology/ Pharmaceutical company or CRO working on Phase I - IV multinational clinical studies.
- 5-8 years clinical project management experience with clinical studies.
An advance degree in scientific, clinical research or regulatory affairs, or business/finance is preferred.
Previous oncology, autoimmune or biosimilar development experience is preferred.
Strong regulatory knowledge including but not limited to Good Clinical Practices (GCPs), ethics requirements for protection of human subjects, set-up and maintenance of Trial Master Files
- Exceptional organizational skills, ability to prioritize, multitask and problem solve.
- Excellent communication skills (written and verbal, including presentation skills)
- Apply project management best practices to programs.
- Proficient with MS Office Suite (Excel, Word and PowerPoint) and MS Project.
- Aptitude for attention to detail and accuracy in work
- Ability and willingness to work cooperatively with others
- Ability to solve routine problems following standard policies/procedures
Curis is a biotechnology company seeking to develop and commercialize innovative drug candidates for the treatment of human cancers. Our most advanced drug candidate is CUDC-907, an oral, small molecule inhibitor of histone deacetylase (HDAC), and phosphatidylinositol-3-kinase (PI3K) enzymes, which has completed the dose escalation stage of a Phase 1 clinical study. Curis is also engaged in a broad collaboration with Aurigene in the areas of immune-oncology and precision oncology. As part of this collaboration, we expect to exercise options to exclusively license small molecule antagonists of programmed death ligand-1 (PD-L1) and interleukin-1 receptor association kinase-4 (IRAK4) and file IND applications for both molecules.
Our most advanced program, a Hedgehog pathway inhibitor program developed in collaboration with Genentech (Roche), led to the commercialization of Erivedge® (vismodegib), the first and only FDA-approved medicine for the treatment of advanced basal cell carcinoma. Genentech/Roche are responsible for the development and worldwide commercialization of Erivedge. Roche and Genentech are also continuing Erivedge®’s clinical development in less severe forms of BCC as well as planned development in other non-oncology indications.
Our corporate culture is focused on learning and growing in a challenging environment with a committed group of peers working together as a team. For more information, visit Curis' website at www.curis.com.
Clinical Sample Operations Manager
Primary Responsibilities and Accountabilities:
Please send CV with job code (CSM200) to:
Human Resources, Curis, Inc.
4 Maguire Rd.
Lexington, MA 02421
Email: email@example.com or Fax: 617.503.6501.
No phone calls please.
Curis, Inc. is an Equal Opportunity Employer.
Our Cambridge based client in the Neuroscience space is looking to give a young hungry scientist an excellent opportunity to break into industry in an excellent work environment. If you have the skills below please reach out ASAP as this is an opportunity that is not often seen for someone with little to no direct industry experience.
Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
CHEMISTRY IS EVERYTHING™
Make an impact at a dynamic and growing life sciences company. inviCRO seeks an accomplished scientist with experience in image processing, particularly image registration and/or segmentation. The ideal candidate possesses graduate-level research experience as well as strong programming, image processing, and signal processing skills.
This position is responsible to develop methodology, software tools, and analysis algorithms for molecular imaging applications with a focus on image registration and segmentation for 3D data sets. Molecular imaging applications span multiple imaging modalities (MR, CT, PET, SPECT, autoradiography, fluorescence, and histology) and disease areas (neuro, oncology, cardio, pulmonary).
Qualifications and Skills:
To apply: Send cover letter and resume indicating your authorization status to work in the United States to firstname.lastname@example.org. Please note job title in the subject line of the email.
Additional information about inviCRO
inviCRO, LLC, was founded in 2008 with a mission to apply imaging technology and tools to address biological questions in drug discovery and development. inviCRO provides state of the art contract research, advanced data analysis services and software for utilization in drug research. In collaboration with partner imaging centers, inviCRO offers full-service contract research in vivo imaging services utilizing SPECT, PET, MR, CT and optical imaging technologies, as well as ex vivo 2D and 3D autoradiography, fluorescence, and histology. Our multidisciplinary team of scientists develop unique imaging and bioinformatics tools that inform the design and analysis of imaging trials across many species and therapeutic areas. Our team brings together specialized knowledge in a broad range of disciplines, including advanced degrees in physics, optics, software engineering, electrical engineering, chemical engineering, mathematics, neuroscience, biomedical engineering and statistics.
We currently manage or support more than 250 pre-clinical and clinical imaging studies per year, processing more than 30,000 medical images per quarter. Our software products are helping scientists at more than half of the top 25 pharmaceutical companies. Visit www.invicro.com for more information.
We are seeking a highly motivated and energetic candidate to lead Momenta’s Drug Product Formulation Development team. The successful candidate will be responsible for planning, coordinating, and managing the formulation and drug product process development/characterization activities, as well as oversight of both employees and contractors for formulation and process development, including associated scale-up, process optimization, technology transfer, and/or validation activities.
The Director of Drug Product Development will be responsible for management of the drug product formulation and process development function, including resource planning and development of an internal laboratory capability. He or she will work closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements and will conduct briefings and technical meetings for internal and external representatives including equivalent or above management. This position will represent Momenta drug product formulation and process development to both internal and external organizations, including CMO/CROs and Momenta's partners.
Job Title: Senior Medical Writer
The senior medical writer is a member of the Medical Writing Group within the Clinical Documentation Department, which is part of Clinical Sciences and Operations (CSO) platform.
Description of position: As an integral part of the clinical team, the position holder ensures the quality, compliance with internal and external standards, and timely production of English-language clinical documents regarding both the project as a whole and individual clinical studies. The position holder must contribute scientific knowledge, analytical skills, experience, and insight into data and document preparation.
·Prepare documents that present clinical data objectively in a clear, concise format. The incumbent must show competence in writing, editing, and reviewing Clinical Study Reports (CSRs) and other clinical regulatory documents.
·Provide dedicated scientific authoring expertise to ensure that the clinical opinion, as defined by the Clinical Study Director and the Clinical Research Director (within the relevant development division or unit) and other clinical leaders, is presented accurately and concisely.
·May need to liaise with external services and review documentation generated elsewhere (e.g., Clinical Research Organisations [CROs], subsidiaries, co-development partners), and internal support staff (e.g., for the preparation of tables, illustrations, and appendices).
·In addition to bringing the required medical writing skills and industry experience, must be willing and able to take responsibility for mentoring and/or training of more junior colleagues, management of Clinical Documentation teams, maintaining close contact with external departments, and coordination of external contractors.
Specific tasks include (but are not limited to):·Produce and update clinical documents, within medical writing scope and competence, to support regulatory submissions and document lifecycle needs according to internal standards and procedures. These include Clinical Investigators' Brochures (CIBs), Drug Safety Update Reports (DSURs), clinical modules for the Investigation Medicinal Product Dossier (IMPD) of the EU Clinical Trial Application (CTA) and the US Investigational New Drug (IND) documentation, and other documents required to support the drug development lifecycle.
·Prepare CSRs and other clinical documentation in collaboration with the Clinical Study Director, and other members of the Clinical Trial Team. This includes coordination of the assembly and QC of CSRs, including appendices. Prepares revisions (following data corrections) and updates (following availability of new data) to study reports and appendices.
·Ensure a consistent style of presentation of clinical documents to maintain quality. Review and edit work of contract writers to ensure quality is maintained.
·Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with counterparts in other departments.
·Participate in the clinical development process for a given compound, by assuming the role of Dedicated Project Expert (DPE) – Medical Writing and interface between the clinical team and the Clinical Documentation team. Regular reporting, anticipation of issues and feedback are essential.
·Coordinate medical writing activities in study teams, including external services. Ensure information sharing among medical writers. Submit suggestions for improving or extending the standards of Clinical Documentation, share with other medical writers experience accommodating special details of clinical studies not covered by standards and technical expertise gained with advanced word-processing, graphics, and other software.
·Review clinical development plans. Advise team members of regulatory requirements for documentation. ·Discuss and develop concepts for improvement in clinical documentation.
·Contribute to production of the clinical registration dossier, using available standards; ensure consistency across regulatory documents following database changes or modifications to the registration package.
·Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/process.
·Already included in above bullet. ·The position holder may manage contractors working in-house.
·Scientific degree, preferably PhD, PharmD, or medically qualified 4-6 years experience as MW, or equivalent, presenting relevant qualifications.
·Experience as DPE - Medical Writing (or similar) on multiple types of clinical documents.
·Skills that are prerequisite for a medical writer (including: appropriate mastery of English, ability to coordinate multidisciplinary teams, respect of deadlines and management of priorities while respecting quality needs, etc.).
·Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment.
·Ability to clearly, accurately, and concisely prepare all types of clinical regulatory documentation, including major submission and/or complex documents in English.
·Excellent interpersonal skills. ·Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills.
·Ability to work independently and proactively within a team.
·Must be deadline oriented, possesing a sense of urgency, accuracy, and be meticulous and attentive to detail.
·Readily adaptable to changes in priorities.
·Solid work ethic, professionalism, organizational ability, and follow-up skills.
·Ability to work on multiple projects simultaneously, while maintaining priorities and high quality results.
·Ability to interact productively with a variety of personalities and to work effectively in an international environment.
·Familiarity with French and/or German would be helpful.
·Ability to take on special projects and assignments without disrupting normal work. #LI-SA
The primary function of this position is the preparation of CMC regulatory documents for the Pharmaceutical Sciences organization. This includes preparation of meeting briefing books, regulatory submissions, meeting documents and responses to associated CMC questions from regulatory agencies. This position will require interactions with other members of the Pharmaceutical Sciences organization as well as the Research organization. Close collaboration with the Regulatory group is essential.
The key responsibilities of this position include but are not limited to:
We are an equal opportunity employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color or any other protected class.
We are a molecular information company focused on fundamentally changing the way in which patients with cancer are treated. Our products provide more than information. They offer hope to patients, their families and friends, their physicians and caregivers. As a member of the Foundation Medicine team you’ll work with everyone fighting the disease—patients and their families, payers, physicians, drug developers—to raise awareness about this transformation in cancer care and Foundation Medicine’s role to ensure we’re delivering the tools and information they need to make an impact and drive access for patients everywhere.
Located in the heart of Cambridge, MA – the world’s preeminent biotechnology hub – we offer competitive salaries, generous benefits and with our rapid growth, ample career opportunities.
What makes Foundation Medicine so special?
The cancer treatment paradigm is evolving rapidly and we believe there is now widespread recognition that cancer is a disease of the genome, rather than a disease defined solely by its specific anatomical location in the body. Today, physicians increasingly use precision medicines to target cancers based on the specific genomic alterations driving their growth, but most currently available molecular diagnostic tests only reveal a few of the possible alterations. Foundation Medicine provides truly comprehensive molecular information products that can assess the broadest range of relevant genomic alterations from a patient’s tumor and distill this complex molecular information into a concise and actionable format that reveals more treatment options for physicians and their patients.
We've seen the difference that our technology can make in the lives of patients, but there is still enormous potential to help even more people. In our drive to help transform the way in which patients with cancer are treated, we strive to improve every life we touch through our dedication to innovation, our commitment to people, and our passion for performance.
The Copywriter will be responsible for writing projects that encompass sales collateral (brochures, sell sheets), direct marketing (email and print), web/interactive, and video scripts.
Director, Regulatory Affairs, Consent Decree and Compliance
This position leads the RA aspects of the Consent Decree remediation activities at the Allston Landing facility, providing feedback to teams focused on Consent Decree and Workplan related activities and submissions. This position also leads the RA aspects of dossier compliance project, tracking RA commitments related to.
Leading the coordination with our global manufacturing sites, integration of regulatory strategy with those sites and communication to senior management.
Provide RA-CMC leadership to project teams as needed, working closely with cross functional teams to compile the required information in accordance with established timelines;
Establish relationships with RA colleagues world-wide and participate in the development of global regulatory strategies and RA-CMC program/process improvements;
Lead, supervise and coach a team of regulatory professionals and be responsible for their development.
Lead other RA CMC projects as needed. Experience working in a matrix environment and excellent people skills are required.
Major Activities/Key Responsibilities
Bachelors degree in a scientific discipline with 10 years experience with a minimum of 5 in regulatory affairs with increasing levels of responsibility.
Biologics RA CMC Experience required.
Knowledge of USA FDA regulations is essential.
Previous experience and demonstrated leadership skills managing and developing a team of professionals
Proficient in MS Word, Excel, PowerPoint, MS Project, and Trackwise.
Excellent organizational and communication (written and verbal) skills.
Demonstrated ability to work successfully on project teams.
RAC certification preferred.
Previous experience working in a fast paced environment on multiple product lines
Manufacturing, QA/QC experience
We are seeking a highly motivated and organized professional with solid knowledge in biological science and/or engineering principles. The individual will play an important role in the day-to-day, hands-on performance of laboratory work.
The successful candidate will be responsible for the execution of experiments for the development, optimization, and characterization of mammalian cell culture manufacturing processes. In addition, the incumbent will be involved in experimental design, data analysis and interpretation, and technical report writing.
We are seeking a highly motivated and energetic candidate for Momenta’s Drug Product Process Development. The successful candidate will be responsible for strategic planning, coordinating, and execution of the drug product process development / characterization activities, as well as oversight of contractors for process development, including associated scale-up, process optimization, technology transfer, manufacturing, and/or validation activities.
The Associate Director of Drug Product Development will work closely with cross-functional teams and leaders concerning projects, operational decisions, and scheduling requirements and will conduct briefings and technical meetings for internal and external representatives including equivalent or above management. This position will represent Momenta drug product process development and manufacturing to both internal and external organizations, including CMO/CROs and Momenta partners.
We are seeking a highly motivated and detail oriented professional with solid knowledge and hands-on working experience in recombinant protein purification process development, optimization, scale-up, tech transfer and GMP manufacturing support. The individual will play a key role in developing purification process for biosimilars and innovative biologics to have desirable product quality attributes. Candidates must have a strong background in protein biochemistry and statistical data analysis. In addition, the responsibilities will include working with both internal and external collaborators to develop and transfer technologies to meet group objectives.
We are seeking a highly motivated, well organized, and detail oriented professional with experience in mammalian cell culture process development and hands-on working experience in tech transfer and GMP manufacturing support. The individual will play a critical role in the tech transfer of cell culture manufacturing process to CMO facilities and on-site support GMP manufacturing. The candidate must be capable of troubleshooting cell culture manufacturing related issues and must possess experience in statistical data analysis and trending. In addition, the responsibilities will include working with both internally and externally collaborators to develop and transfer technologies to meet group objectives.
The Manufacturing Support Supervisor is responsible for oversight of Receiving, Storage, Shipping and Transport of Vericel materials and products.
The goal of the lab is to improve human health by developing computational techniques and interfaces that enable biomedical and clinical investigators to efficiently interact with biomedical data. We design, implement and evaluate methods and tools that leverage the knowledge and cognitive skills of investigators in order to enable the interpretation of massive heterogeneous data sets that integrate genomic and clinical data. Please see http://gehlenborglab.org for additional information about our work.
Possible research projects include development of data visualization, analysis, and management tools to study genomic structural variants, dynamics of the 3D genome, and cancer subtypes in patient cohorts. Further projects involve the design and implementation of visual exploration tools for biomedical data repositories and tools for viewing and interacting with provenance graphs. All of the projects are highly interdisciplinary and are being conducted in close cooperation with computational or experimental domain experts providing an excellent opportunity for collaborative research.
Our lab in the Department of Biomedical Informatics is part of a vibrant community of scientists, physicians, and engineers whose goal is to advance the boundaries of knowledge. The Department has recently been formed at Harvard Medical School to lead development of computational and informatics techniques to address pertinent challenges in modern biological sciences and medicine. The Department’s faculty conduct research at the intersection of biomedicine and information sciences, including bioinformatics, functional genomics, translational medicine, and clinical knowledge management. Based on the Harvard Medical School Longwood Campus, it provides a rich scientific environment, with many seminar series and invited speakers of the highest caliber.
The postdoctoral fellows will be responsible for developing novel methodologies and applications to facilitate visual analysis of massive heterogeneous biomedical data sets, including genomic and clinical data. While the focus of the positions is on the development of visualization approaches, the roles will also involve the integration of such tools with data analysis and data management tools.
Other responsibilities include day-to-day project management, including coordination with collaborators and other team members, as well as the writing of manuscripts. Contribution to the grant writing efforts of the lab are expected.
Candidates must have a PhD degree in a quantitative field such as bioinformatics, computational biology, biomedical informatics, medical informatics, computer science or related fields and a track-record of publication in the top journals or conferences of their field. Hands-on experience with management, analysis, and visualization of biomedical data as well as experience in developing (web-based) interactive software tools are required for this position. Excellent programming skills and working knowledge of state-of-the-art software development techniques are essential. The candidates interested in these positions must be highly motivated, willing to learn and demonstrate initiative in assigned tasks. Excellent written and verbal communication skills are crucial.
The positions are available immediately and can be renewed annually.
How to apply
Candidates should submit their CV, a research statement, PDFs of their three best papers, and contact information for three references to email@example.com with [POSTDOC] in the subject.
Harvard Medical School is an Equal Opportunity/Affirmative Action Employer. Women and minorities are especially encouraged to apply.
A laboratory at the newly-formed Department of Biomedical Informatics at the Harvard Medical School (HMS) is looking to recruit several postdoctoral fellows interested in pursuing one or more of the following topics in computational biology:
I. Single-Cell Genomics. The fellow will be charged with developing novel statistical approaches to analysis of single-cell genomic data, mathematical modeling of cellular processes, as well as applications of such techniques to studies healthy and diseased tissues. Strong background in statistics, modeling of stochastic processes and multicellular systems is desired.
II. Computational analysis of epigenetic mechanisms disrupted in cancer and other disease-disrupted tissues. The fellow will be responsible for developing and applying computational methods for integrative analysis of genome-wide epigenetic, transcriptional and proteomic data, aiming to identify specific factors and molecular mechanisms underlying misregulation of the epigenetic states in several types of human cancer. The ideal candidate should have strong quantitative background, ample experience with analysis of sequencing assays, and strong interest in cancer biology.
III. Computational analysis of nucleosome organization. The fellow will be part of the central analysis group for the extensive 4D-nucleus consortium project funded by the NIH. The efforts will be focused on development of analysis techniques for the next generation of experimental methods for measuring organization and dynamics of the eukaryotic nucleus that are being developed by the members of the consortia. Experience with analysis of Hi-C and relevant imaging data is strongly preferred.
All of the projects are being conducted in close cooperation with the expert bench-side laboratories, providing an excellent opportunity for collaborative research. The Harvard Medical School and the Department also provides rich scientific environment, with a number of relevant seminar series, invited speakers, and many neighboring laboratories working on related projects. Please see http://pklab.med.harvard.edu/ for additional information about the laboratory.
PhD in Computational Biology, Statistics, Physics or other related discipline is required. A strong record of publications in the field is desired.
How to apply
Please send cover letter, curriculum vitae and contact information for at least two references to Dr. Peter Kharchenko at firstname.lastname@example.org. Applications will be considered until the positions are filled. Please specify which project you are interested in.
The Department of Biomedical Informatics has been recently formed at the Harvard Medical School to lead development of computational and informatics techniques to address pertinent challenges in modern biological sciences and medicine. The Department’s faculty conduct research at the intersection of biomedicine and information sciences, including bioinformatics, functional genomics, translational medicine, and clinical knowledge management. The Department also hosts the Bioinformatics & Integrative Genomics PhD program (sponsored by NHGRI) and the Biomedical Informatics Masters program.
Harvard Medical School is an Equal Opportunity/Affirmative Action Employer.
Women and minorities are especially encouraged to apply.
Postdoctoral Positions in the Lab of Griffin Weber
Areas of focus
Statistical Modeling of the Scientific Workforce
The Weber Lab in the Department of Biomedical Informatics (DBMI) at Harvard Medical School is seeking a Postdoctoral Fellow to help model the scientific workforce. The scientific workforce is increasingly relying on teams to solve the most critical intellectual and social problems that confront us today. Team collaborations, a growing trend across all disciplines, yield publications with higher intellectual impact than single researchers; and, the careers of young scientists are influenced by relationships with others in the community. We are developing a systems-based approach to studying scientific workforce dynamics that models the mechanisms of how new collaborations form and how these influence both the effectiveness of teams and the career trajectories of individual scientists.
The Postdoctoral Fellow will be responsible for developing statistical and computational approaches to linking large sources of data about the scientific workforce (e.g., 50 million publications, 4 million patents, 2 million grants) and analyzing the collaboration networks of scientists. There are opportunities to study a wide range of related topics, such as the role of interdisciplinary teams, international collaborations, and diversity (e.g., gender, race) in science. The Postdoctoral Research Associate will gain experience writing scientific papers and presenting at scientific seminars and conferences.
The Weber Lab is funded by NIH and NSF grants to develop algorithms and open source software for analyzing biomedical "Big Data". We created a social networking website for scientists called Profiles RNS and contributed to a program for querying clinical data about patients called i2b2. Both of these systems are used in dozens of institutions worldwide.
In addition to this project on the scientific workforce, there is a separate project in the Weber Lab developing probabilistic algorithms for linking patient data across biomedical datasets, such as electronic health records, administrative claims, and genomic data. This project is also seeking a Postdoctoral Fellow. There will be synergies between the two projects since both involve linking and analyzing large datasets.
Candidates must have a PhD or other advance degree in statistics, computer science, biomedical informatics, or a related field. A strong background in statistical modeling is required. Some experience programming or working with databases is needed due to the size of the data, though database programmers within the Weber Lab will be available for help and training.
Candidates should be highly motivated, creative, and interested in learning new skills. They must enjoy solving complex and challenging problems and being part of a multidisciplinary research team. Excellent written and verbal communication skills are essential.
Experience with R statistical software and/or Microsoft SQL Server is desirable. Experience with social network analysis, natural language processing, or data visualization would also be helpful for the project.
The position is available immediately and can be renewed annually.
How to apply
Email applications including curriculum vitae, summary statement of personal objective and research interests, PDFs of the best two papers, and the names and email addresses of three references to: Griffin M Weber, MD, PhD, email@example.com.
Harvard Medical School is an Equal Opportunity/Affirmative Action Employer.
Women and minorities are especially encouraged to apply.
Company: 121Bio LLC
Location: Cambridge, MA
Position: Protein Biochemist (6 month temp position)
Qualifications and experience:
At Boston Children’s Hospital, success is measured in patients treated, parents comforted and teams taught. It’s in discoveries made, processes perfected, and technology advanced. In major medical breakthroughs and small acts of kindness. And in colleagues who have your back and patients who have your heart. As a teaching hospital of Harvard Medical School, our reach is global and our impact is profound. Join our acclaimed Urology Department and discover how your talents can change lives. Yours included.
The Research Assistant I will be responsible for:
To qualify, you must have…
A research assistant position is available in laboratory of Dr. Richard S. Lee MD within the Urological Diseases Research Center at Boston Children's Hospital. The Lee lab is involved with developing and applying new glycomics and glycoproteomics methodologies for the interrogating the urinary proteome and tissues of the urinary tract to identify novel and clinically relevant markers of urologic disease, in particular renal damage, urinary tract infection, and bladder dysfunction. Primary responsibilities would include According to prescribed protocols and assigned schedules, performs a variety of routine laboratory tests and procedures, utilizing standard laboratory equipment, recording and checking results for completeness and accuracy. May suggest alternative routine procedures to crosscheck own findings. Performs the following techniques typically required for the laboratory/study: Maintains records of results and methodologies in a log of work performed. Maintains equipment, lab area and supplies in a neat professional manner. May sterilize and clean glassware, disposing of specimens, media and other materials using appropriate procedures. Inventories supplies and alerts supervisor to needed supplies or mixes standard reagents. Contributes to the teamwork within and between departments and organizations.
Boston Children’s Hospital offers competitive compensation and unmatched benefits, including affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, cell phone plan discounts and discounted rates on T-passes (50% off). Discover your best.
Boston Children’s Hospital is an Equal Opportunity / Affirmative Action Employer. Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, sexual orientation, gender identity, protected veteran status or disability.
Associate Scientist/Scientist Protein Engineering
PhD Scientist needed for bacterial protein expression, protein purification, protein characterization, and some experimental design. Techniques include: FPLC, His-tag, protein conjugation, and flow cytometry. Strong level of independence working in a fast-paced environment within a team environment. Position is a full-time (40 hr/week) contract role and located in Cambridge.
The Director of Clinical Development Operations is responsible for clinical study planning, execution, timelines and budgets for multiple clinical development programs. These responsibilities includes, but are not limited to, vendor identification and selection, preparation of study related materials, relationship management between study sites and vendors; in particular CRO(s), supervision of study related activities, identification of project risks and contingency planning. Additionally, this person will participate in growth of the Clinical Operations Department and will build processes and infrastructure required according to best industry standards. The Director of Clinical Operations will oversee a group of Clinical Project managers, Clinical Trial Managers and Clinical Research Associates.