Quality Systems, Sr. Specialist

Join our growing Quality group

Contribute to bluebird bio’s enthusiastic and collaborative Quality Systems team to enable the overall success of our novel gene therapy approach.  This position will support the establishment of the bluebird bio Quality Management System (QMS) aligned with industry standards and in accordance with the relevant product’s lifecycle.  In this role you will support and/or co-lead the development, implementation, and maintenance of various bluebird bio Quality Systems including: Deviations/NC, CAPA, Change Control, LMS and Quality Metrics.  These activities will encompass IND-enabling, pre-clinical, clinical and commercial initiatives. This is a great opportunity to have a major impact on developing the quality function and quality culture at bluebird bio.       

About the role:

• Develop the QMS to support early-stage clinical, late-stage clinical and future commercial operations
• Assist and or co lead  in the identification, validation, implementation and maintenance of electronic Quality Systems
• Provide subject matter expertise to assure deviations, CAPA and change control records meet regulatory requirements and industry practices.
• Lead risk assessment initiatives in close collaboration with internal and external interfaces
• Compile and evaluate quality metrics for dissemination at Quality Council and Management Review
• Function as Business/System owner for electronic Quality Systems
• Review, revise, and approve GxP controlled documents to ensure compliance and facilitate continuous improvement
• Assist with corporate and/or third party audit and inspection readiness activities

About You:

• BA/BS in a scientific discipline and a minimum of 5+ years experience in a Quality Assurance/Quality Systems role
• Experience with implementing and validating electronic Quality Systems with an understanding of Part 11 compliance
• Strong knowledge in the development of a robust QMS
• Knowledge of US and EU cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
• Skills to lead cross functional teams to effectively resolve quality issues
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
• Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
• Excellent communication skills and ability to influence across multiple functions
• Ability to travel approximately 10-20%
• Be ready to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

Success Factors:

• Experience navigating multiple programs through various phases of pre-clinical and clinical development
• Experience with the validation of computerized systems preferred
• Effectively partnering with internal and external organizations
• Auditing experience (preferably CQA certified) a plus
• Risk management experience (FMEA, PHA, etc)
• Project management experience
• LEAN/Six-Sigma Green Belt a plus
• Experience supporting regulatory inspections and audits
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision
• Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers

This is an exciting time to join the field of gene therapy in general, and to become a part of the bluebird bio team in particular.  bluebird bio is a publicly traded company on the NASDAQ  Global Select Market and trades under the symbol BLUE.  We were named to the 2012 FierceBiotech Fierce 15. We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc. 

The NGS Sequencing Lead will be responsible for the development of sequencing chemistry related aspects of a QIAGEN next generation sequencing workflow.  In this role the NGS Sequencing Lead will lead a team of scientists and technical staff in a matrix role. The position will be responsible to deliver all technical performance aspects of the sequencing process. Proactive interaction across different groups and departments is expected. We are looking for a skilled and motivated Lead with experience in managing a team and next-generation sequencing technologies.

The NGS Sequencing Lead will:

• Direct the development of all aspects of the sequencing segment of the NGS workflow, including chemistry, disposables, cooperate with hardware and software
• Ensure that all development activities within this area are compliant with QIAGEN global product development procedures
• Supervise the activities of a team of scientists and technical staff in a matrix management role
• Deliver the required technical performance of the sequencing process according to specification, on time and within budget
• Work collaboratively with other groups and departments (e.g. Operations department, Project Management) within the project to contribute to the successful development of the NGS workflow, from sample to insight
• Mentor and develop staff under their direction (in matrix role)
• Oversee experimental analysis to facilitate troubleshooting and development decision
• Experience with product development under design control is preferred
• Represent QIAGEN at scientific conferences and other outward facing events

REQUIREMENTS

• PhD in Chemistry, Biochemistry, Molecular Biology or related fields
• Preferably 7+ years of relevant industry experience
• Excellent understanding of the underlying technical principles of next generation sequencing chemistries and workflows, associated instrumentation platfoms and data analysis and interpretation algorithms
• Mandatory experience in next generation sequencing (NGS) technology and product development with a documented record of success in the life sciences and/or molecular diagnostics space
• Strong management skills with a track record of increasing responsibilities and the management of groups in a matrix; international experience preferred
• Very good troubleshooting, problem solving and organizational skills
• Proven leadership and successful decision-making qualities
• Strong technical writing and presentation skills
• Strong intellectual property protection skills and patent record
• Moderate travel required (up to 20%)

Working Environment Mechanical hazards, chemical hazards, biological hazards
Physical Requirements Sit, move, speak, hearing acuity
Lifting Requirements Sedentary work (exerting up to 10 pounds of force)

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Technical Assistant I

10/2015

The Whitehead Institute for Biomedical Research in Cambridge, MA is seeking an experienced scientist in large-scale genetic screening of mammalian cells to develop a platform for conducting CRISPR-based screens.

Whitehead Institute for Biomedical Research is a leading, nonprofit research and educational institution that has defined the cutting edge of biomedical science, creating a legacy of research excellence and academic eminence since 1982.​ Wholly independent in its governance, finances and research programs, Whitehead shares a teaching affiliation with Massachusetts Institute of Technology (MIT), offering the intellectual, collegial and scientific benefits of a leading research university.​ Whitehead’s Faculty Members and Fellows run pioneering programs in cancer research, immunology, developmental biology, stem cell research, regenerative medicine, genetics and genomics—programs with a record of success.​

Director David C.​ Page likens the Institute to an artists’ colony.​ “What we do here at Whitehead is attract the best possible intellectual capital and empower maximally creative—really wildly creative—individuals to realize their dreams within these walls”.​

Classification:              Exempt: Research Staff

Reports to:           Principal Investigator or other supervisory lab personnel

OVERALL RESPONSIBILITY

Performs bench level experiments and small independent research projects to support research objectives of the Sabatini lab. Analyzes experimental data, addresses methodological problems in experimental protocols and results, and reports data to supervisor. Works as part of a team to execute high-throughput lentiviral CRISPR-based screens, including lentivirus production and infection of cultured cells. Responsibilities include cell culture and screening in a high-throughput facility.

CHARACTERISTIC DUTIES

• In consultation with the Principal Investigator or other project manager, conducts bench level experiments and small independent research projects.

• Perform cell culture on up to 20 cell lines. Accurately monitor for contamination and cell line fidelity.
• Attend team meetings. May participate in scientific conferences and contribute to scientific journals.

• Documents, compiles, and assists in interpreting experimental data.  Reports data in oral and written reports.
• Operates lab equipment and prepares and orders necessary supply stocks.  May work with vendors to address equipment, reagent, or supply issues.

• Operates and maintains laboratory equipment to complete investigations.
• Prepares, orders, and maintains stocks of necessary reagents, solutions, and supplies.
• Consult with literature and scientific staff to maintain professional expertise
• Other tasks as required or assigned,

QUALIFICATIONS

• Bachelor’s degree in biology or a field directly related to the work. 
• Proficiency in basic lab techniques and principles of molecular biology required.
• Experience with tissue culture.
• Knowledge of various scientific databases and publications preferred.
• Excellent written and oral communication skills and the ability to interact with all levels of staff and external contacts.
• Exceptional organizational and critical thinking skills; lab notebook practices and attention to detail are essential.
• Ability to solve complex problems.
• Ability to exercise judgment within defined practices and techniques.

Interested candidates should submit a resume and cover letter to resumes@wi.mit.edu

Or mail to:

Human Resources

Whitehead Institute

9 Cambridge Center

Cambridge, MA 02141

Our amazing client is a leader in antibody based therapeutics with a novel platform and they need you to help them develop their external and eventually internal capacities for antibody discovery and development. You will need to be an expert in interfacing with CROs early on to get them to partner with you for company success. Successful Scientists will also have worked hands on with Antibody production with phage or yeast display. You will be involved in making decisions to discovery and humanize antibody therapies with this exciting and growing team as a vital member of the protein and antibody production group.
Ideally you will have a can-do personality with the ability to problem solve and work under deadline driven timelines to successfully build a first-in-class antibody platform. Come join this impressive management and scientific team and help change the face of biological therapeutics. Contact Chris Clancy today 603.766.0600 or contact through LinkedIn.
About StratAcuity:

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™

Provides leadership and support to project teams on all statistical programming matters according to the global project strategies within the assigned group (BU, or TSU/DPU). Leads one or more projects for all programming deliverables through the project milestones from study start-up to regulatory submission and approval and post marketing support. Collaborates with statisticians and programmers across geographic locations to ensure high quality and timely statistical programming deliverables; ensures compliance to internal standards and SOPs. Participates in the identification and development of programming standards and macros to facilitate the creation of statistical deliverables, as well as in process improvement activities. Works with programming management to identify resource needs based on project milestones and deliverables. Acts as mentor to junior staff with regard to programming techniques, project management and implementation of standards.

The incumbent can assume the role of B&P data standards leader, providing leadership in WW data standardization activities and expertise in regulatory submissions, as well as collaborating across the CSO platform to support the development and implementation of data standards and tools in B&P, in the framework of industry standards, regulatory requirements and CSO business strategy. 

Lead one or more programming projects following company standards, processes, tools and applications. Independently coordinate and oversee the preparation, execution, reporting and documentation of project analysis programming, proactively identifying issues and recommending solutions. Provide project management and technical guidance to ensure operational and technical excellence. Collaborate with statisticians and programmers to define and implement analysis requirements and electronic data submission strategies. Provide programming support for the development and QC of analysis datasets and outputs for individual study as well as integrated analyses.

Ensure high quality and timely statistical programming deliverables which meet BU/TSU/DPU expectations and regulatory requirements.

Data Standards Leader:
Define and/or improve the strategy for the implementation of the global data standards in B&P based on industry standards, regulatory requirements and CSO governance. Lead the development, implementation, maintenance and support of SA data standards.
Lead expert support to WW project teams and SA regulatory operations to ensure high quality and timely statistical and eSub deliverables that meet industry standards and regulatory requirements

Mentor junior level staff in programming practices, implementation of standards and project management.

Foster team building and a collaborative work environment. Ensure consistency and efficiency in programming practices.

Act as programming representative in a multidisciplinary study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports.

Ensure project milestones are met to facilitate decision-making and address business needs.

Data Standards Leader:
Build regulatory submission standard expertise (e.g. data standards, preparation of define.xml and etc) through interaction with RegOps and FDA, and participation in CDISC; Ensure harmonization of data standards from data collection through submission; particularly by way of providing inputs to the CRF design and database structure to ensure sufficient alignment of standards between data collection and analysis/reporting. Collaborate with the TIM group on the development and maintenance of tools and systems linked with data standards.

Develop data models, programming standards and codes, and training end users in the use of project standards to support programming deliverables that follow regulatory submission requirements.

Develop programming code according to standards to reinforce standardization and improve programming efficiency.

Support department initiatives and task forces. Lead/participate in departmental or cross-functional working groups and process improvement activities.

Continuous improvement of best programming practices and technologies.

Maintain knowledge of new technologies, industry standards, regulatory requirements, and CSO guidelines and SOPs. Implement the quality control procedures that are operationally optimized and in compliance with regulatory requirements.

Ensure daily programming practices meet industry standards and are consistent with internal SOP

Qualifications: 
A candidate with a Bachelor or Master of Science degree or equivalent in Statistics, Computer Science, Mathematics, Engineering, Life Science or related field, preferred.

A candidate with a Master degree and 7+ years of programming experience peferably in processing clinical trial data in the pharmaceutical industry.

A candidate with a Bachelor degree and 9+ years of programming experience peferably in processing clinical trial data in the pharmaceutical industry. 

Advanced SAS programming skills in a clinical data environment with expertise in at least one, preferably multiple, therapeutic areas.

Thorough understanding of relational database structures and their correlation to submission ready database structures. Knowledge of CDISC data structure requirements.

The role of data standards leader requires in-depth knowledge in industry data standards, regulatory data submission requirements, and demonstrated experience in the development and implementation of standard methodology.

Proven ability to work collaboratively on interdisciplinary teams. Strong interpersonal skills that demonstrate initiative and motivation. Proven ability to solve complex problems. Excellent verbal and written communication skills in a global environment.

Strong skills in project management requiring no supervision. Ability to effectively organize and manage multiple assignments with challenging timelines, from project start-up through submission.

Knowledge of regulatory requirements concerning electronic submission standards and experience in delivering one or more submissions to regulatory authorities globally.

Knowledge of pharmaceutical clinical development in one or multiple therapeutic areas (i.e. therapeutic area endpoints, understanding of statistical concepts, techniques and clinical trial principles) and ability to lead regulatory submissions.

Ability to mentor junior staff in programming techniques, data standards, project management and communication.

Ability to project and embody company values in day to day operations.

Knowledge & Skills Desirable but Not Essential:
Experience with other operating systems and packages such as UNIX, MS Office
Experience with other Statistical and Graphics software packages such as SPLUS, JMP
Experience with other programming languages such as C+, JAVA
Knowledge of clinical data management systems, e.g., Oracle Clinical and/or RAVE.

Overview:

Alnylam is a rapidly growing biotechnology company with offices in Cambridge MA (USA) and Uxbridge, UK, focused on the discovery and development of siRNA therapeutics. The Clinical Operations Team seeks a highly motivated person with excellent computer skills, who is highly attentive to details, has strong organizational skills, and able to communicate effectively in a fast paced environment. Major responsibilities for this position include maintenance of informational databases and program tracking reports, participate in coordination of clinical trial related activities, authoring of study operations manuals, budgetary oversight and tracking, and providing general program support in a team setting to ensure the successful execution of clinical trial tasks and deliverables according to project timelines. Duties may include, but are not limited to, subject tracking, assembly, review, quality control, and tracking of regulatory documents, maintenance and tracking of study materials (including investigational drug), generation and distribution of meeting agendas and minutes in addition to other activities.

Summary of Key Responsibilities:

This entry-level candidate will also be required to:

• Effectively and efficiently interact with internal, clinical site and vendor personnel.
• Have the interest and ability to expand knowledge of clinical trial management procedures and regulatory submission requirements.
• Learn health care authority regulations and guidelines, and apply to daily activities.
• Perform day-to-day activities based on Standard Operating Procedures and Good Clinical Practice (GCP).                                                    
• Learn and execute defined tasks while working closely with others.
• Assist with in-house coordination of activities related to conduct of clinical trials.
• Demonstrate problem-solving skills, including the identification of problems and proposed solutions, in consultation with more senior team members.
• Possess good verbal skills and seek information when needed.
• Seek opportunities to learn and be receptive to constructive feedback.
• Benefit from close supervision but be willing to work independently.
• Receive guidance on clinical development process and the role operations plays in that process.
• Track progress across multiple programs and communicate this to internal and external stakeholders.
• Organize trial and program related team meetings, associated agendas, and generate meeting minutes, including tracking of action items.
• Become familiar with and assist in maintaining clinical invoice tracking and other budget databases for multiple projects, generate periodic reports on status of payments and other database reports, and resolve payment inquiries from investigator sites.
• Maintain other informational databases for clinical trial status throughout the life of a clinical program.
• Train to monitor clinical sites / data under the direction of experienced clinical research personnel through co-monitoring visits.
• Travel as needed, although requirements are minimal (less than 20% for non-monitoring related work; potential at times for up to 50% for monitoring related travel).

• BS/BA degree in healthcare / scientific field preferred
• Minimum of 1 year work experience in related field
• Some experience working in a contract research organization and/or clinical trial environment is preferred
• Entry level is acceptable

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

GENERAL DESCRIPTION/FUNCTION:   

Based in Boston, Massachusetts, the incumbent will identify, develop and nurture strategic new business relationships, identify prospects and pursue potential opportunities in order to increase awareness of Paragon Bioservices’ CDMO business in the New England Region. Primary focus will be in the pharmaceutical and biotechnology industries, NGOs and academic institutions.

DUTIES & RESPONSIBLITIES:  

• Responsible for managing the entire CDMO business cycle including identification and qualification of leads
  • Expand Paragon’s brand awareness in the region
  • Develop and execute regional strategies to identify and target potential new customers through effective market, revenue, and literature analyses
  • Contribute to short- and long-term territory business plans through in-depth understanding of revenue streams and potentials
• Manage the territory through the use of the company’s customer relationship management (CRM) tool and provide forecast reporting to management on a routine basis
  • Update and maintain the CRM database through rigorous documentation of all communications with clients and potential clients
• Responsible for winning new customers and projects, and for maintaining repeat business
• Participate with the Business Development and Technical Teams in the overall process for:
  • Proposal generation,
  • Responding to requests for information (RFI) or proposal (RFP),
  • Contract negotiation, and closing
• Supply management with oral and written reports on customer needs, problems, interests, competitive activities, and potential for new products and services
• Work closely with and effectively communicate with other members of the Business Development and Marketing teams, and collaboratively with internal cross-functional teams (i.e., Project Management, Process Development, GMP Operations, Quality, and Finance)
• Attend and actively participate in all regional industry tradeshows, conferences, networking events, and client on-site and off-site meetings, as well as internal Business Development meetings
• Contribute to team and departmental initiatives outside of day-to-day regional sales & business development activities
• Accountable for meeting/exceeding performance metrics including quarterly regional revenue goals

SKILLS & TECHNICAL EXPERTISE:  

• Excellent organizational skills
• Demonstrated success in developing new business, and growing existing business
• Fundamental knowledge/understanding of science and bioprocessing concepts
• Outstanding interpersonal and oral/written communication skills, with an emphasis on clarity and accuracy
• Models a visible sense of urgency in accomplishing daily tasks and in coordinating with internal groups
• Maintains a professional appearance and projects an approachable/positive company image to the public

SUPERVISION:

Minimum supervision required on day-to-day activities and accomplished tasks

EDUCATION/PREVIOUS EXPERIENCE:

• BS in a scientific discipline, business, or related field (MS, MBA, or PhD is a plus)
• 3–5 years of business development or sales experience in the biopharmaceutical CDMO, pharmaceutical, biotechnology, or life sciences industries
• Experience/understanding of the proposal development process, business quotes, budgeting and managing to defined timelines
• Proficiency in Microsoft Word and Excel is required, experience with Microsoft Project and Salesforce.com is a plus
• Must be highly motivated and able to work independently

Primary candidates ONLY. No recruiting agencies.

No relocation available.

Interested parties are encouraged to mail their CV with a cover letter to:

Paragon Bioservices, Inc.
Attn: Human Resources
801 W Baltimore St
Suite 401
Baltimore, MD 21201

Or

resume@paragonbioservices.com 

Please reference the job code when submitting your CV for this position: BD_10.12.2015_BDRM_TP

Seeking an experience Quality Assurance professional with experience in the biotechnology industry. The company is looking for a proven leader with experience managing direct reports, CAPAs, and a team.

MUST HAVE:
1) Bachelor's degree in life sciences or similar
2) 8-10 years in life sciences manufacturing industry
3) Demonstrated experience in a supervisory/management role with direct reports
4) SME in Quality Systems management, managing processes for CAPA, deviations, non-conformancies, customer complaints, etc


Quality Systems Manager will lead a team of dynamic Quality Specialists (approx. 10-12 Specialists) at our main location. 
Job Duties
- Responsible for quality assurance systems and performs activities in compliance with ISO 9001:2008 and 13485:2003 standards.

- Responsible for review and disposition of manufactured products and incoming raw materials. 
- Coordinate and lead Quality investigations and resolving potential quality discrepancies for raw materials, in-process material and final - Performs investigation and resolution of customer complaints including preparation of communications with customers. 
- Performs internal and supplier audits. 
- Coordinate and/or perform review and approval of internal documentation such as SOPs, specification documents, and master batch records.

*In addition to the above responsibilities, this person will also manage the day to day functions of the Doc Control team consisting of 2-3 direct reports.

We are seeking a highly motivated and energetic candidate to join our analytical development group. The successful candidate will be responsible for planning, coordinating, and executing activities associated with our biosimilar and biologic product programs. Included in these activities will be acting as a technical resource for internal and external projects.  This is an individual contributor position, which requires the ability to work as a member of a team of talented scientists in a cross-functional environment.  The successful candidate will be comfortable working in a laboratory environment and with modern instrumentation. This position may require occasional international travel. 

Required Skills 

• Ability to initiate, direct, and execute scientific activities associated with corporate strategies.
• Broad knowledge of state-of-the-art principles and theories associated with the characterization of complex drugs, including therapeutic glycoproteins.
• Experience with modern scientific instrumentation and methods, including hyphenated LC methods, cIEF, CE, glycan analysis, binding assays and immunochemical methods
• Participate in the development and integration of our biosimilar analytical strategy across multiple development programs
• Management and support of analytical programs with external partners and/or CMO organizations
• Actively support the preparation of the characterization and the analytical sections of regulatory filings 

Required Experience  

• Strong Analytical Chemistry background with expert level skills in the characterization and analysis of proteins and the implementation of analytical programs in support of product development. Working level experience with technology transfer and support of contract manufacturing organizations.
• Excellent communication skills, including the ability to work in a multi-lingual environment. 
• Experience in development of analytical / bio-analytical programs and strategies for product development
• Demonstrated experience with the preparation of analytical CMC sections of regulatory submissions is preferred
• Experience in working as a part of cross functional teams in a multi-project environment is also required
• Ph.D. degree in Analytical Chemistry, Physical Chemistry, Biochemistry or related field and 10+ years of industry experience with demonstrated leadership potential.
• Ability to travel internationally.

SVP for boutique life sciences agency

This will seem like an unconventional job description.  It is.  But I am working on a unique search.

I have been known to quiver when an agency client approaches me for help on a search for a life sciences communicator, regardless of level.  What I hear from prospective candidates is that they love their current agency or they’d only move for an in house role.  I get it.

But this time, I actively sought out the assignment.  I know the agency well.  And they are unlike other agencies.

• Independent. Make decisions rapidly.  Look at the long-term and big picture for decision-making.  Flat.
• Rapid, yet controlled, growth.  20+ FT employees in multiple offices.  Companies seek out their services – it’s not a business development role
• Tailor-made for people who love the craft of communication - the chance to really work hands-on with clients and provide both strategic and tactical guidance.
• Clients are emerging life sciences companies; mostly early stage.  They rely on my client for strategic counsel on messaging/positioning, media relations, social/digital strategies and investor relations support.
• They want people who have been there, done that and have credibility in the industry.

It’s an SVP-level position based in Cambridge, MA.

Company Overview:

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

Job Description:

Under the direct supervision of the Vice President of Clinical Operations, the Associate Medical Director is responsible for the day-to-day supervision of primary medical care services. S/he will provide sound medical guidance and direction in the design and safety management of Berg clinical trials. This position combines direct service with hands-on administrative responsibilities in support of all Clinical programs. Working as a collaborative partner with the Chief Medical Officer and the Vice president of Clinical Operations, the incumbent provides real-time analysis and recommendations for improvement in clinical operations across multiple levels/functions. In addition, the position works internally to represent Clinical in special programs/projects for the effective integration of multidisciplinary patient/client services across multiple departments.

Responsibilities:

• Assumes clinical responsibility for monitoring the safety of patients enrolled in Berg clinical trials; assumes Site Supervision role as directed.
• Facilitates Clinical Protocols/Guidelines for the development and implementation of safety programs for clinical operations.
• Attends and represents Berg at specific institutions, and at conferences, as requested to enhance collaborative efforts with these organizations and institutions.
• Addresses site needs continuously.
• Provides overall direction and coordination of continuing medical education, training, and support for clinical teams. 
• Assists in medical decision-making, as requested and as necessary.
• Maintains an up-to-date understanding of all clinical and regulatory changes in the US and elsewhere.
• Assists in the design, implementation, and evaluation of clinical programs.
• When directed, assumes responsibilities and authorities of Chief Medical Officer, on an interim basis as required to ensure regulatory compliance and patient safety.
• Collaborates with Management Team members, as directed, to develop strategies and policies and provides consultation within scope of responsibility.
• Provides additional assistance within and outside of clinical arena, as requested and/or as appropriate, to ensure the ongoing success of the organization.

Qualifications:                                                     

• Requires an MD degree with a minimum of 3 years’ experience in small biotech environment with an oncology focus.
• Clinical proficiency in oncology.
• Understanding of early Phase drug development.
• Knowledge and understanding of US and ex-US regulations.
• Previous experience with managing drug safety in early Phase clinical trials.
• Demonstrated ability to work effectively independently and as part of a team, in collaborative settings
• Maintains affiliation with appropriate professional organizations.
• Understands and is committed to maintaining highest level of confidentiality.
• Willingness and ability to work some evenings and weekends, as needed.
• Ability to utilize computer technology preferred, and willingness to develop and adapt to the evolving technological requirements of modern medical health center practices required.
• Demonstrates flexibility in regards to job duties and assignments.

Contact:

Send resume to hr-52853@berghealth.com

Company Overview:

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

Job Description:

Reporting to the Vice President of Clinical Operations, the Associate Director of Clinical Operations provides oversight and contributes to the clinical operations of Berg Pharma studies while working collaboratively with the CROs, third-party vendors, site investigators and research staff contracted by Berg Pharma.  Oversees operational aspects of all clinical studies worldwide and ensures effective cross-functional teamwork among project team members both internal and external services. This person plays a key role in developing processes, procedures and SOP in a growing organization. The Associate Director of Clinical Operations supervises and directs the work of the assigned staff.

Responsibilities:

• Monitor project schedule and scope to ensure both remain on track; implement and follow pre-approved procedures for any deviations.
• Develop spreadsheets for clinical budgets and timelines.
• Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met according to Berg Pharma requirements.
• Ensure that all staff allocated to assigned project(s) adheres to professional standards and SOPs.
• Prepare and actively participate as operational lead in internal Project Review meetings. Depending on size and scope of project, this job duty may be performed in collaboration with a senior member of the Clinical Operations team.
• Create required project plans; implement and monitor progress against project plans and revise as necessary; review clinical protocols, CRF's, study reports, and informed consent forms.
• Ensure that clinical research is cost effective by analyzing internal and external costs, resource utilization and performance data
• Plan & identify resources for global clinical studies based on project timelines
• Negotiate & establish contracts and budgets with external resources
• Develop training programs for internal and external resources
• Ensure work is performed in accordance with industry standards, federal and state regulations, accreditation standards and Berg Pharma mission and core values.
• Ensure adherence to protocols and compliance with GCP, ICH, GMP, and regulatory guidelines.
• Participate in global research activities such as creating IBs, INDs, study document filing.
• Audits of vendors (Clinical, CMC).
• Participate in quality and/or process improvement activities.
• Comply with all safety and work rules, policies and procedures.
• Perform audits of work on a regular basis; initiate and implement corrective actions with results.
• Prepare reports, documents, statistical surveys and other such data as required.
• Other related duties as assigned.

Qualifications:

• Requires a BS degree in a scientific discipline with a minimum of 8 years of clinical operations experience in the pharmaceutical industry and/or CRO, with a strong preference for experience in small oncology biotech.
• Excellent MS Office applications skills, especially well-versed in the development and use of Excel spreadsheets.
• Strong understanding of regulatory requirements.
• Ability to communicate effectively with physicians, fellow employees, patients, guests, contractors and vendors.
• Strong problem-solving skills and flexibility in a growing organization.
• Attention to details; ability to maintain confidentiality and security.

Contact:

Send resume to hr-52853@berghealth.com

About Veristat

Join a team that works on groundbreaking compounds and profoundly impacts patients’ lives! Veristat is a distinct, full-service contract research organization with offices in California, Massachusetts, and Quebec. Due to our growth and investment we have recently relocated our headquarters to Southborough, MA. Veristat is serious about scientific integrity and has a dynamic company culture, including a focus on work-life balance. 

Veristat’s Value Proposition for You

• Flexible work schedule.

• Proven potential for professional growth.

• A community of brilliant minds at your disposal.

• The stability of working for a robust, financially sound CRO that is growing at a sustainable pace.

• Exposure to more than 20 therapeutic areas, including cutting edge therapies such as immuno-oncology, biosimilars, gene therapy, and new molecular entities.

As a Vice President of Biometrics You Will…

• Be a critical part of the global core Leadership team by being responsible for the guidance and strategic direction of the global Biostatistic and Data Management teams.

• Advance the overall success and future growth of Veristat by having executive contact with current clients, providing key client oversight and strategic project contribution, and contributing to new business development.

• Develop and implement department strategies to increase productivity and quality, while decreasing cycle times and costs. Oversee the data management and statistical aspects of client projects and project teams.

• Participate in presentations of capabilities and research proposals to prospective clients. Represent Data Management and Biostatistics in marketing efforts by developing project bid proposals, participating at bid defense meetings, or performing client presentations.

• Provide oversight of the hiring and management of personnel. Ensure that adequate training occurs and that performance evaluations are completed.

• And more!

Education

Degree in Statistics, Biostatistics, math, or a related field. PhD or Master’s degree preferred.

Experience

• At least 15 years of relevant work experience and at least 5 years of supervisory experience.

• Experience in a leadership position within Biostatistics or Data Management for a CRO.

• Have previously contributed to the overall strategic direction of a company or business unit.

• Thorough knowledge of ICH GCP guidelines and other applicable regulatory rules and guidelines and of medical terminology, clinical trials, and clinical research.

• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotech companies.

About Veristat

Join a team that works on groundbreaking compounds and profoundly impacts patients’ lives! Veristat is a distinct, full-service contract research organization with offices in California, Massachusetts, and Quebec. Due to our growth and investment we have recently relocated our headquarters to Southborough, MA. Veristat is serious about scientific integrity and has a dynamic company culture, including a focus on work-life balance. 

Veristat’s Value Proposition for You

• Flexible work schedule.

• Proven potential for professional growth.

• A community of brilliant minds at your disposal.

• The stability of working for a robust, financially sound CRO that is growing at a sustainable pace.

• Exposure to more than 20 therapeutic areas, including cutting edge therapies such as immuno-oncology, biosimilars, gene therapy, and new molecular entities.

As a Vice President of Clinical Operations You Will…

• Be a critical part of the global core Leadership team by being responsible for the guidance and strategic direction of the global Project Management and Clinical Monitoring teams.

• Advance the overall success and future growth of Veristat by having executive contact with current clients, providing key client oversight and strategic project contribution, and contributing to new business development.

• Develop and implement department strategies to increase productivity and quality, while decreasing cycle times and costs. Oversee the project management and clinical monitoring aspects of client projects and project teams.

• Participate in presentations of capabilities and research proposals to prospective clients. Represent Project Management and Clinical Monitoring in marketing efforts by developing project bid proposals, participating at bid defense meetings, or performing client presentations.

• Provide oversight of the hiring and management of personnel. Ensure that adequate training occurs and that performance evaluations are completed.

• And more!

Education

Degree in a health related discipline. PhD or Master’s degree preferred.

Experience

• At least 15 years of relevant work experience and at least 5 years of supervisory experience.

• Experience in a leadership position within Project Management or Clinical Monitoring for a CRO.

• Have previously contributed to the overall strategic direction of a company or business unit.

• Thorough knowledge of ICH GCP guidelines and other applicable regulatory rules and guidelines and of medical terminology, clinical trials, and clinical research.

• Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotech companies.

Medical Writer/Senior Medical Writer, Medical Affairs

Cambridge-basedgene therapy company

With our lentiviral-based gene therapy and gene editing capabilities, we have built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. Our clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). We also have ongoing preclinical CAR T immuno-oncology programs, as well as discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. As a primary member of the Medical Affairs organization, the Medical Writer is responsible for developing publications and other key externally facing scientific communication documents, including manuscripts, abstracts, posters, and slide decks. The Medical Writer will also provide writing and editorial support for other critical Medical Affairs communication and educational initiatives. Working to ensure that bluebird’s core data in an emerging scientific field are clearly understood, this person will help to shape the international scientific discourse around clinical applications of gene therapy.  The successful candidate will have ample ability to grow and contribute to the success of the Medical Affairs organization and to bluebird bio’s overall success.

About the Role:

• Work  with internal and external stakeholders to prepare both clinical and preclinical manuscripts and other publications that convey bluebird bio’s overall clinical and scientific objectives
• Contribute to the Medical Publication Strategy for multiple clinical-stage research programs
• Provide writing and editorial support for educational activities and advisory boards
• Develop positive and productive relationships with authors, working to  best represent their point of view while aligning with bluebird bio’s medical publication strategy
• Participate in the development of style guide, lexicon, publication work practices, and other core resources for a growing Medical Communications and Publications team
• Contribute to overall project management and to cross-functional working groups as needed to facilitateefficient development and finalization of documents

About you:

• Experience as a professional clinical medical writer who has led the development of high-impact manuscripts, abstracts, and posters; understanding of the scientific publications process and familiarity with Good Publication Practice guidelines; in-house industry experience preferred
• Expertise in one or more of the follow fields preferred: gene therapy, genetic diseases, HSCT, benign hematology, hematologic oncology
• Well-organized with a strong sense of urgency, ability to prioritize tasks, work simultaneously on multiple projects, and complete high‑quality documents under tight timelines
• Independently motivated with good problem-solving ability and excellent attention to detail
• Demonstrated understanding of medical statistics/biostatistics and aptitude for compilation, analysis, and presentation of data
• Ability to effectively manage multiple contributors with various points of view and priorities to produce a unified and effective final document
• Graduate degree in life sciences or equivalent combination of education and experience required
• Fully fluent in spoken and written English; demonstrated ability to communicate and write clearly, concisely, and effectively
• Readiness  to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, ad b yourself

bluebird bio is a publicly traded company on the NASDAQ  Global Select Market and trades under the symbol BLUE.  We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

bluebird bio, 150 Second Street, Cambridge, MA 02141 www.bluebirdbio.com

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.

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=YXN0YW5pdHMuMzY0OTMuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Primary Role
Working under the direction of the Head of LMS Application Services director, the LMS BA is a bridge between the Business and Shire's enterprise learning management system which is Saba. This position will leverage the individual's LMS expertise, work experiences and best practices, ensure effective business requirements identification, perform functional analysis, technical design and integration, and solution implementation and delivery. This role requires strong partnership and collaboration with functional business users, LMS systems administrators, IT, and vendor partners.

The BA will also participate in the development of the LMS roadmap and future system strategies, seek continuous improvement opportunities in LMS functionality/ capability and provide recommendations/ proposals in which the technology will enable improved business processes resulting in process efficiency and business benefit.

The individual will maintain a focus of user-centric design and responsive end-user support. The incumbent will have a high degree of the technical expertise, collaboration, and a strong client service orientation.

Responsibilities
40%
Requirements Analysis: Working with team and end users towards defining a solution that will meet the agreed requirements including documenting and analyzing business inputs, modelling the business domain using process diagrams, flowcharts, data models, exploring behavior models (use case, user experience design, storyboards, wireframes, user profiles and user stories), assessing business architecture, performing gap analysis, conducting feasibility studies, and verifying and confirming requirements.

40%
Collaboration: Collaborate with the Enterprise Application architect, LMS systems administrators, support team and approved external service providers to produce options, and recommendations for implementation of change requests and/or projects. Maintain and develop knowledge of current and emerging technologies/ solutions, assesses their relevance and potential value to the organization, and contributes to briefings of staff and business management. Leverage best business practices when designing LMS capabilities to deliver business needs while providing a sound Enterprise Approach.

10%
Elicitation: Working with stakeholders to help them understand their requirements within the scope of a project including eliciting requirements, brainstorming options, analyzing documents, running focus groups, analyzing system interfaces, interviewing stakeholders and subject matter experts, observing real-time activities and work environment, facilitating requirements workshops, reverse engineering existing systems, and collecting input via surveys and questionnaires.

10%
Compliance: Comply with all change control procedures and Standard Operating Procedures (SOPs) in the support of existing functionality, requested changes, and in the development of new functionality. Contribute to the maintenance of Shire's LMS in a compliant solution.

Education & Experience Requirements
* Bachelor's degree in computer science, or a related study, required
* 3-7 years of relevant IT/Business experience including project scoping, analysis and documentation of business and technical requirements
* Experience with working with 3rd party external vendors and managing application service management providers.
* Experience in pharmaceutical industry, computer systems validation, and learning management functional systems domain preferred. Experience in Saba and Workday integration is a plus.
* Experience consulting and working in complex, global matrix organization is preferred

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=anN0Z2VvcmdlLjE5NDE4LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

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

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

Role Description
The qualified candidate will play an important role on both small molecule and biologic research programs within the Inflammation and Immunology Research Unit portfolio. More specifically the position will be focused on the research and development of ligands and antibodies targeting G-protein coupled receptors. The candidate will have extensive in vitro experience in the characterization of GPCRs in particular the quantification of agonist and orthosteric and allosteric antagonist action at GPCRs in recombinant and human isolated native cellular systems. The candidate will have broad experience in the development and execution of GPCR in vitro assays including radiometric and fluorescent based receptor ligand binding assays, intracellular calcium mobilization, cAMP accumulation and B-arrestin recruitment. The candidate will also be experienced in assessing the physiological responses of immune cells to inflammatory agents including cellular adhesion, chemotaxis and cytokine
release. The individual will be required to develop novel, sensitive and relevant cell based functional assays to address unmet drug screening needs.

Responsibilities

• As in integral member of the Receptor Pharmacology Team the candidate will be responsible for advising project teams on the most suitable cellular system and in vitro experimental endpoints to characterize the effect and mode of action of receptor agonist and antagonist agents.
• Develop these in vitro assays so they can either be used in production mode or used in a bespoke manner to answer detailed questions regarding an agents mode of action (kinetics, biased signaling, allosterism). 
• Enhance the Receptor Pharmacology Team’s capabilities through actively keeping up to date with receptor theory and new technologies.
• Present ideas, recommendations and results at project and discipline team meetings. 

Qualifications

• Educated to MSc with 5+ years or PhD with 2+ level in biochemistry or pharmacology preferably with industrial experience the ideal candidate will have a strong history of rigorous technical accomplishments.
• A proven record of the development and execution of novel receptor ligand binding and functional assays to characterize the actions of agonists and antagonists at G-protein coupled receptors. Experience in generating these assays using both recombinant and human isolated immune cells systems.
• A proven track record of analyzing and interpreting complex in vitro pharmacology data using linear and non-linear regression models and the appropriate reporting of the endpoints from these models. Through exposure on multiple GPCR programs the candidate will have gained experience in interpreting atypical pharmacology data.
• Extensive experience in working with human whole blood and the subsequent isolation of immune cells.

A strong organization and project management skills.

• Technical expertise in developing and executing in vitro receptor ligand binding and functional cell based assays.
• Experience in working with recombinant systems and human isolated immune cells from human whole blood
• Experience in analyzing complex in vitro pharmacology data sets and through previous GPCR pharmacology experience have a strong ability to interpret and rationalize results.

Physical/Mental Requirements:
Laboratory focused role working in the lab.

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

Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4wMjgxNC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

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

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

Role Description
The Cardiovascular and Metabolic Diseases Research Unit is focused on identifying targets and developing compounds for the treatment of Diabetes and its complications. We are seeking motivated self-aware individuals with excellent oral and written communication skills and a deep interest in biological sciences. The successful candidate will able to learn quickly, ask questions as needed, function in a team environment and have some knowledge of the drug development process.

Responsibilities
Activities will include:
* Mammalian cell culture, nucleic acid/protein isolation and quantitation, PCR, RT-PCR, Westerns, ELISAs, and tissue extractions.
* Assay development execution in support of identifying and optimizing drug candidates.
* Animal dosing and handling (rats and/or mice) with measures of metabolic endpoints.
* Quantification and translation of experimental results to advance understanding of how metabolic pathways and complex physiological systems are altered by the diabetic- disease state, and how they respond/adapt to therapeutic interventions
* Maintenance of laboratory notebook records and adherence to safety policies is strictly required.

Qualifications
Education and Experience:

• BA, BS or MS with laboratory experience in appropriate scientific areas relevant to this position

A degree in the following is strongly preferred:

•  Biochemistry, Cell Biology, Physiology, Biomedical Engineering, Chemical Biology, Quantitative Biology

Technical Skills Requirements:

Successful candidates will have 4+ years post-graduate research experience and demonstrated skills in the following:
* Effective bench scientist, proficient in a range of lab techniques detailed above.
* Detail oriented and organized; able to grasp complex procedures and adapt appropriately
* Capable of completing experiments with limited supervision
* Experience in analytical and/or bioanalytical methods, with the capability of applying this in an efficient, highly interactive, goal-oriented team environment.
* Ability to grasp complex procedures, and adapt appropriately.
* Proven verbal and written communication skills, and the ability to work in a collaborative team environment.
* A working knowledge of statistics as it applies to experimental design and be able to conduct data analysis using Microsoft Excel, GraphPad Prism or equivalent software.
* A strong technical background in mathematics and/or engineering, including an understanding of the use quantitative models for understanding complex systems.
* Ability to complete experiments and present results in individual and group settings, including experience using Microsoft PowerPoint or equivalent software for this purpose.

Physical/Mental Requirements:
Regular laboratory bench work and desk work will be performed by this person.

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

Application URL:http://www.aplitrak.com/?adid=amVmZnJleXN0b25lLjQyMjg5LjMxNjdAcGZpemVyLmFwbGl0cmFrLmNvbQ

Manager/Senior Manager, Medical Communications

Cambridge-basedgene therapy company

With our lentiviral-based gene therapy and gene editing capabilities, we have built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. Our clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). We also have ongoing preclinical CAR T immuno-oncology programs, as well as discovery research programs utilizing megaTAL/homing endonuclease gene editing technologies.

Join bluebird bio’s enthusiastic and collaborative team by contributing to the overall success of our novel gene therapy approach. As a primary member of the Medical Affairs organization, the Medical Communications Manager is responsible for strategy and development of  publications and other key externally facing scientific communication documents, including manuscripts, abstracts, posters, and slide decks. The Medical Communications Manager will also provide writing and editorial support for other critical Medical Affairs communication and educational initiatives. Working to ensure that bluebird’s core data in an emerging scientific field are clearly understood, this person will help to shape the international scientific discourse around clinical applications of gene therapy.  The successful candidate will have ample ability to grow and contribute to the success of the Medical Affairs organization and to bluebird bio’s overall success.

About the Role:

• Work  with internal and external stakeholders to prepare both clinical and preclinical manuscripts and other publications that convey bluebird bio’s overall clinical and scientific objectives
• Contribute to the Medical Publication and Education Strategies for multiple clinical-stage research programs
• Provide writing and editorial support for educational activities and advisory boards
• Develop positive and productive relationships with authors, working to  best represent their point of view while aligning with bluebird bio’s medical publication strategy
• Participate in the development of style guide, lexicon, publication work practices, and other core resources for a growing Medical Communications and Publications team
• Contribute to overall project management and to cross-functional working groups as needed to facilitateefficient development and finalization of documents

About you:

• Experience as a professional writer who has led the development of high-impact manuscripts, abstracts, and posters; understanding of the scientific publications process and familiarity with Good Publication Practice guidelines
• Expertise in one or more of the follow fields desirable: gene therapy, genetic diseases, HSCT, benign hematology, hematologic oncology
• Well-organized with a strong sense of urgency and standard of quality; ability to prioritize tasks and work simultaneously on multiple projects
• Independently motivated with good problem-solving ability and excellent attention to detail
• Demonstrated understanding of medical statistics/biostatistics and aptitude for compilation, analysis, and presentation of data
• Ability to effectively manage multiple contributors with various points of view and priorities to produce a unified and effective final document
• Graduate degree in life sciences or equivalent combination of education and experience required
• Fully fluent in spoken and written English; demonstrated ability to communicate clearly, concisely, and effectively
• Readiness  to embrace the principles of the bluebird bio culture:  b colorful, b cooperative, and b yourself

bluebird bio is a publicly traded company on the NASDAQ  Global Select Market and trades under the symbol BLUE.  We offer a fast-paced, dynamic, collaborative, colorful, and scientifically rigorous environment, with all the fun and passion that a start-up provides, plus an excellent benefits package that includes stock options, commuter/parking benefit, etc.

bluebird bio, 150 Second Street, Cambridge, MA 02141 www.bluebirdbio.com

bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.