We have a great opportunity for a Director of Marketing at Celldex Therapeutics. This person will report to the VP, Commercial. The experienced candidate will work cross- functionally with commercial, medical, research, business development and manufacturing team members to ensure commercial success.

Responsibilities include managing key strategic and operational marketing activities to ensure optimal global commercialization of our lead program. The successful candidate will develop and oversee the disease education plan, commercial launch plan, product positioning, brand development, KOL engagement plan as well as pricing, reimbursement and market access plans. This person will also liaise with corporate communications for advocacy planning. This person will also develop and manage the product budget. Other responsibilities include managing external vendors, overseeing market research and identifying new partners that bring value to the organization. The marketing director will hire, manage and develop marketing team members.

The successful candidate should have at least 8-10 years industry experience with 5 years of oncology marketing experience, including pre-launch and in line marketing responsibilities. Experience in a biotech environment is desirable.

Strong analytical and strategic thinking skills required

Ability to integrate data from multiple sources and formulate key insights

Strong communication skills

Proven ability to manage direct reports and cross-functional teams

Have scientific background or evidence of ability to grasp understanding of scientific concepts.

Team player

BA/BS required, MBA preferred

https://home.eease.adp.com/recruit/?id=3842241

Position: Sr. Process/ Manufacturing Engineer

Daktari Diagnostics, Inc. is a Boston-based company developing innovative diagnostic tests for global health conditions. The core technology combines microfluidics with electrochemical sensing. Our initial product, a point-of-care CD4 testing system for use in HIV disease staging worldwide, will provide a CD4 cell count result in less than 10 minutes from a finger stick of blood, anywhere in the world. This handheld system includes a disposable assay cartridge comprised of molded plastics, microfluidics, integrated sensors, and chemistry, and a low-cost electromechanical instrument.

Responsibilities include, but are not limited to:

• Responsible for process transfer and product scale-up development by supporting development and implementation of manufacturing processes at external manufacturing sites.

• Work closely with external manufacturing partners to define, develop, implement, validate, and transfer the CD4 Cartridge, sub assembly and component manufacturing processes to volume manufacturing.

• Design and develop processes for manufacturing using statistics based experimentation and principles of six sigma process excellence.

• Work closely with R&D and quality groups to ensure manufacturability of design.

• Develop qualification plans for equipment/process and execute. Oversee IQ/OQ/PQ of production processes at external manufacturing partners.

• Provide guidance to other engineers and technicians to support project completion. Requirements:

• B.S. in Mechanical Engineering or similar with 5+ years’ experience in process and equipment development.

• Prior experience with Medical Device process development and semi-automated manufacturing processes preferred.

• Excellent interpersonal skills to allow effective collaboration within project teams both internal and external.

• Experience with Quality System Regulation (QSR), Design Control and Process Validation guidelines, Engineering Change Controls, ISO, and Design Control and Regulatory procedures is preferred.

• Good understanding and use of statistical methods in experiment design and data analysis is preferred.

• Up to 30% travel both domestically and internationally is required.

  Salary commensurate with experience; potential equity participation.
  Please contact work@daktaridx.com for more information. Please reference code MO03.

  Daktari Diagnostics is a dynamic, start-up environment committed to bringing the highest quality medical diagnostics to everyone, everywhere.

Visit www.daktaridx.com for more information. 

Position: Data Analytics Engineer

Daktari Diagnostics, Inc. is a Boston-based company developing innovative diagnostic tests for global health conditions. Our initial product, a point-of-care CD4 testing system for use in HIV disease staging worldwide, will provide a CD4 cell count result in less than 10 minutes from a finger stick of blood, anywhere in the world. This handheld system includes a low-cost electromechanical instrument and a disposable assay cartridge comprised of molded plastics, microfluidics, integrated sensors, and chemistry. Daktari is looking for a Data Analytics Engineer to function as part of our R&D team to process a variety of data creating information that can be used to analyze the effectiveness of various sub-systems in our in-vitro diagnostics systems. The data sources include fluorescence microscopy images, real-time impedance measurements, general-purpose test & measurement equipment, and processed spreadsheet data. Information to be supported by the Data Analytics Engineer includes development of metrics for the analysis of output data, counts of biological objects represented in images, and comparison of experimental processes with control processes. Responsibilities include, but are not limited to: • Developing tools to analyze image and numeric data, using a variety of platforms including ImageJ, python, excel, minitab, and similar systems • Working with the science and engineering staff to interpret analysis, and to help guide process optimization for the CD4 platform • Extracting and condensing data for presentation to a technical audience Requirements: • BS in a computationally rigorous field including applied mathematics or physics • Demonstrated ability with the analytic application of mathematical principles to extract information in raw data • Curiosity, attention to detail, rigorousness, and self-motivation. • Ability to work independently in a start-up environment

Daktari Diagnostics is a dynamic, start-up environment committed to bringing the highest quality medical diagnostics to everyone, everywhere. Please contact work@daktaridx.com for more information. Please reference code RD22.

We have an immediate opening for a Scientist / Sr. Scientist in biochemical assay development and optimization.

The Scientist / Sr. Scientist will participate in interaction with QA/QC and Manufacturing to generate relevant SOPs, DHRs and other control documents as projects are transferred to Manufacturing. The Scientist / Sr. Scientist will also participate in design of QC assays and generate appropriate QA documents for product manufacture, playing a significant role in the Design Control process throughout product development, presenting at Design Control meetings, generating Design Inputs, Design Outputs, Risk Analysis documents and Failure Modes Analysis documents.The Scientist / Sr. Scientist will assist in clinical trial protocol development and assist senior management with FDA regulatory compliance issues. 

Position Requirements:

Requires PhD in biology or chemistry with 2-4 years industrial experience with in vitro Diagnostic Assay Development.Knowledge of GLP, GMP and QA/QC protocols and regulatory compliance is required.Strong background in biology and biochemistry is essential.Research backgrounds with blood proteins and/or in bacteriology are strongly preferred.Hands-on experience with automated liquid handling instrumentation highly desired.

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represent ground breaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.

Job Summary and Responsibilities:

•         Develop and implement lifecycle management processes

•         Lead cross-functional product development teams from inception through completion on complex, substantial projects that are strategic to the business

•         Independently develop and implement project plan, timeline, budget, and performance metrics

•         Track project progress, evaluate project risks, develop risk mitigation and contingency plans

•         Organize and maintain records of team meetings

•         Maintain proper documentation per product development process

•         Serve as internal focal point for critical project information and communicate project status updates to immediate supervisor, senior management and other stakeholders

•         Facilitate discussions on project issues and implement resolutions

Knowledge and Skills:

•         Direct responsibility in leading global cross-functional product development team for medical devices (project budget >$2M) with minimal supervision

•         Demonstrated ability to adhere to project timeline and stay within budget

•         Demonstrated ability to establish and maintain effective working relationships across functions with key stakeholders

•         Demonstrated ability to anticipate and facilitate discussions on complex issues

•         Experience in design control process

•         Demonstrated proficiency in project management tools - create project plan, develop budget, track performance metrics

•         Working knowledge of US and international regulatory requirements as well as  good clinical and manufacturing practices

Basic Qualifications:

BS in life science, physical science or engineering with 10+ years of product development experience in medical device or biotech industry; 7+ years of direct project management experience in a medium- to large-size company (200+ employees) OR MS in life science, physical science or engineering with 7+ years of product development experience in medical device industry; 5+ years of direct project management experience in a medium- to large-size company (200+ employees); Experience in managing and leading global cross-functional product development teams; Experience in managing product development projects involving human clinical studies

Preferred Qualifications:

MBA degree and Experience in direct management of a human clinical study, relevant experience may include protocol generation, study preparation, study monitoring, data management and publication of clinical study report

 Please apply online at: www.Genzyme.com/careers job number 31696

Establishes financial status by developing, implementing and managing systems for collecting, analyzing, verifying, and reporting financial information; managing staff at Intelligent Medical Devices (IMDx).

 Primary Responsibilities

 Operations

• Responsibility for the establishment and adherence to IMDx Accounting policies and procedures
• Maintains Accounting controls by updating the chart of accounts; defining Accounting policies and procedures
• Manage the company’s banking and legal requirements
• Maintains financial security by establishing internal controls
• Furnish internal reports and furnish external reports as necessary
• Direct the annual financial statement audit and prepare Accounting memos as necessary
• Responsible for corporate governance issues, including  tax filings and planning, and compliance with all federal, state, and local corporate, payroll, and other applicable taxes
• Confirms financial status by monitoring revenue and expenses; coordinating the collection, consolidation, and evaluation of financial data; preparing special reports

 Accounting

• Maintain the general accounting system
• Manage the Accounts Payable and Receivable functions (i.e. enter invoices, perform vendor account reconciliations, process payments, collections, cash deposits, wires, etc.)
• Own the physical inventory process to ensure the proper flow of daily operations and accuracy
• Manage month-end and year-end closing processes including preparing and reviewing journal entries to properly reflect financial activity, account reconciliations, financial statements for accuracy, account analysis, accruals, etc.
• Analyze general ledger accounts for month-to-month income statement and balance sheet variances, research accounts and recommend solutions
• Prepare monthly financial report package and ad hoc reports as requested
• Supervise Accounting staff including developing performance goals and measurements and providing necessary training, coaching and counseling to ensure corporate objectives are met
• Participate in internal control reviews and audits and apply GAAP principles to maintain financial credibility
• Assist the Controller with various projects as assigned

 JOB QUALIFICATIONS & EDUCATION:

•  5-10 years in an emerging growth company, preferably in the life sciences industry.
• BA/BS in Accounting
• CPA
• Cost accounting experience a plus
• Able to prioritize, direct and manage a large number of activities.
• Familiarity in contract drafting, review, and management.
• Ability to draft Accounting memos in order to support the company’s accounting      policies (i.e. revenue recognition, inventory, stock compensation, etc.)
• Familiarity in negotiating licensing, royalty, and co-development deals with life sciences partners
• Knowledge of Dynamics GP (Great Plains) is essential.
• Have an entrepreneurial spirit, prepared to take calculated risks in pursuit of goals.
• Be comfortable in a fast paced growth environment with an appropriate balance of urgency and quality.

 Interested candidates should submit cover letter and resume to careers@intelligentmdx.com and reference Job Code: AM-130

Reporting to a Disease-Area Safety Head, GPS Director (Physician) will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS

GPS Director (Physician) will perform both individual and aggregate case review, as well as support and/or lead periodic safety signaling reviews and meetings. GPS Director (Physician) may also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.

KEY RESPONSIBILITIES:     
- Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
-Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources.
- Conduct medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed.
- Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
- Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
- Contribute to preparation and review of periodic reports (IND, Annual Safety, PSUR)
- Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
- Participate in departmental development activities including SOP and Work Instructions development.
- Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
- Provide a contributory role in Partner /Affiliate agreements and interactions, as needed.
- As directed by a Disease-area Safety Head, assume primary responsibility/chair for the conduct of one or more Disease-area Safety Team(s) for assigned products.
- Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with Vertex signal detection practices.
- Other activities, as needed or as requested by GPS management.

Minimum Qualifications
- Solid knowledge of General Medicine, including a doctorate in Medicine (M.D.)
- Adequate knowledge of GCP, ICH and Global regulations.
- At least 3 years Pharmacovigilance experience
- Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents.

Preferred Qualifications
- Sound ability to communicate effectively in a matrix environment.
- Experienced in the evaluation and interpretation of data
- Sound knowledge of current Benefit-Risk principles
- Ability to multi-task
- Solid written and oral communication skills.
- Solid judgment and decision-making skills, including the identification and communication of relevant safety-related issues or concerns to GPS Management in an appropriate and timely manner.
- Close attention to detail.

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

The Medical Writer prepares clinical regulatory documents.  This individual interprets and summarizes data for regulatory submissions.

Responsibilities
- Prepare clinical study protocols, clinical study reports, Investigator’s Brochures, and clinical sections of regulatory submissions such as annual reports
- Write, review, and edit documents to ensure clarity, consistency, and adherence to Vertex standards
- Manage timelines for clinical sections of regulatory submissions
- Participate in the development and maintenance of SOPs, work instructions, standards, and templates

Minimum Requirements
- Advanced scientific degree (PhD)
- At least two publications

Preferred Qualifications
- At least 6 months of clinical regulatory medical writing experience
- Outstanding written and oral communication skills
- Proficiency in teamwork, organization, and project management
- Ability to understand the basics of pharmaceutical industry processes and requirements of study design, analysis, conduct, drug development, and reporting for regulatory submissions
- Hands-on experience in writing clinical study protocols and clinical study reports

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

Predictive Biosciences is seeking a detail-oriented individual with significant laboratory billing/collection experience, ideally in the molecular diagnostics area, to fill the position of Reimbursement Manager.

The reimbursement manager’s primary role is to support effective and efficient billing, contracting, accounts receivable and collection functions.  In this role, the reimbursement specialist works with PBS employees, and external parties including billing vendor, and customers.

Responsibilities:

Work with external billing company to maximize collection from assigned insurance companies to ensure timely payment and maximum reimbursement

• Proactively identify payer issues and work with both internal and external resources to resolve the issues.
• Obtain other data elements such as physician NPI number, ICD-9 coding
• Organize and forward billing information to outside billing vendor, including assignment of charges for the claim
• Perform client verification on OIG
• Maintain a reference  document for negotiated fee arrangements Maintain a charge entry log for  allcases completed, indicating billable vs. non-billable, outside vs. direct billed, etc.
• Work closely with laboratory personnel and IT personnel in connection with data maintained in our LIS system -- Orchard
• Coordinate activities with Laboratory management
• Prepare deposits for all remittances
• Assist the Finance Department in the overall valuation of net realizable value of accounts receivable
• Manage outside billing vendor  relative to transactions processed, management reports, and information needs
• Assist with credentialing packages and create and manage tracking system for enrollment applications

 Qualifications:

Must have a minimum of 5 years’ experience working in reimbursement, medical billing and/or collections.

• Strong customer service and verbal communication skills are a must.
• Knowledge of CPT, HCPCS and ICD-9 coding.
• Excellent organizational, communication, multitasking and teamwork skills.
• Applicable experience
• Familiarity with billing and medical (laboratory preferred) terminology
• Very detail oriented
• Appropriate IT skills
• Ability to interact with internal staff, vendors, patients and customers – excellent people phone skills
• Understanding of reimbursement issues and policies, and ability to communicate them effectively

As the Associate Director of preclinical development you will be a key member of the Product Development team reporting to the VP of Preclinical development and CMC. In this hands-on position, you will plan, develop and implement preclinical development strategies, which include establishing overall project goals and objectives that lead to timely product IND/CTA filings.

The candidate will work closely with project teams to design studies that support team goals. The successful candidate will work well independently, anticipate and solve technical problems, possess good interpersonal skills and work well in a team, will be objective-driven, and will understand and meet project timelines

Responsibilities include:

• Design, implement, validate and manage a range of in vivo pharmacology and DMPK studies to support early stage development programs and progression of development candidates.
• Plan and execute in vitro and in vivo metabolism studies in preclinical species (including in vitro metabolic stability, P450 inhibition, reaction phenotyping, and metabolite identification/isolation, transporter assays)
• Manage  bioanalytical programs of methods development and validation, with CRO’s, adhering to pertinent GLPrequirements.
• Modeling and Prediction of human dose, pharmacokinetics and therapeutic window to support development decision
• Designing pharmacokinetic components in various clinical studies including first-in-human and drug-drug interaction studies. In addition, the individual will contribute to pharmacokinetic analysis, interpretation and reporting of pharmacokinetic results from clinical trials
• Support food effects, drug-drug interaction, bioequivalence and population PK/PD studies.
• Prepare protocols, timelines and budgets for preclinical studies, monitoring studies and critically reviewing study results and reports.
• Prepare verbal and written summaries for internal discussions and for regulatory submissions, anticipating and resolving preclinical issues that arise during product development.
• Interact with the research team to identify new indications and/or sensitive subpopulation for current indications using translational in-vivo models in oncological diseases
• Maintain currency in regulatory agency nonclinical/clinical pharmacology and toxicology regulations/guidelines
             

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:

(Experience and qualifications will determine position level)

PhD in pharmacology, toxicology, DMPK or related pharmaceutical sciences.

• 6-10 years of experience in pharmacology disease models, pharmacokinetics, toxicology, drug metabolism and/or clinical pharmacology within the pharmaceutical industry required.
• Excellent problem-solving skills and the ability to work independently and in a cross-functional team.
• Familiarity with Win-nonlin/Phoenix, and/or NONMEM, GastroPlus      etc. is a plus
• Possess excellent communication skills, including the ability to speak, write and understand English to comply with written procedures, instructions, SOPs and other documents.
• Demonstrated problem-solving, organizational and communication skills.
• Proven success record in developing preclinical programs and supporting submission of regulatory documents in a biotech company.
•  A specific background in oncology is preferred.

Company Overview

Based in Cambridge, Good Start Genetics, Inc. conducts genetic diagnostic carrier testing for the reproductive market.  Our clinical molecular diagnostics laboratory is CLIA and CAP certified. Good Start Genetics is building a great team with experienced professionals. Please visit www.goodstartgenetics.com for more company information.

We seek a highly motivated individual who can utilize their superior organizational skills to support the functions of our clinical laboratory operations. 

Hours:  Monday-Friday 10:00 AM to 6:30 PM.  Potential Saturday coverage needed.

Responsibilities:

Operation Support

• Enters patient results
• Provides assistance reviewing, printing and faxing patient reports
• Emails client notifications
• Communicates with Customer Care regarding test delays, and client requests
• File, manage and prepare paperwork for storage

Laboratory Support

• Receives patient samples and performs patient test order entry and data verification
• Liaises between Lab and Customer Care for resolution of patient specimen related issues
• Prepares paperwork and samples for send out
• Manages shipment resolution and shipping kit inventory and recycling
• Scans, and organizes sample paperwork

Requirements

• Requires a high school diploma; preferred Associates or Bachelor’s degree in a science related field
• Experience working in a clinical laboratory setting preferred
• Familiarity with medical or laboratory terminology a plus
• Previous data entry experience and/or ability to type 35 wpm
• Ability to work both independently and in a team environment
• High attention to detail
• Excellent organizational and time-management skills
• Superior oral and written communication skills
• Ability to work in a fast-paced environment

Compensation: 

• Competitive salary, commensurate with experience
• Benefits package available includes: Medical, dental, vision insurance, Life and disability insurance, 401(k) plan, bonus plan, paid vacation and holidays

To Apply

To apply please reply to this post with a resume and cover letter which specifically addresses why you are interested in this positions, why you are qualified, specific examples of success in similar positions, your work style, and when you are available to begin working

The Technical Marketing Manager, Hospital Products develops and presents technical product sales training to international subsidiaries and dealers. The product lines include blood gas/critical care analyzers and point of care glucose testing systems. The Technical Marketing Manager will also give product education seminars to hospital customers of POC glucose testing systems and will be the liaison to certain private label customers, (distributors), to oversee product performance. Requirements: PhD in Clinical Chemistry, Analytical Chemistry, or related field, work experience with Medical Products, customer oriented attitude. 

-Serves customers by identifying their needs; engineering adaptations of products, equipment, and services.
Engineering Sales Job Duties:
• Identifies current and future customer service requirements by establishing personal rapport with potential and actual customers and other persons in a position to understand service requirements. Provides product, service, or equipment technical and engineering information by answering questions and requests.
• Establishes new accounts and services accounts by identifying potential customers; planning and organizing sales call schedule.
• Prepares cost estimates by studying blueprints, plans, and related customer documents; consulting with engineers, and other professional and technical personnel.
• Gains customer acceptance by explaining or demonstrating cost reductions and operations improvements.
• Develops customer's order by providing technical information and proposals.
• Prepares sales reports by collecting, analyzing, and summarizing sales information and engineering and application trends.
• Maintains professional and technical knowledge by reviewing professional publications and resources
• Contributes to sales engineering effectiveness by identifying short-term and long-range issues that must be addressed; providing information and commentary pertinent to deliberations; recommending options and courses of action; implementing directives.
Skills/Qualifications:
Bachelor degree preferred, if not, entrepreneurship experiences can be a substitute
Problem Solving,
Selling to Customer Needs,
Familiarity to Office Software, especially WORD, EXCEL and POWERPOINT
2+ years Business Development or sales experiences,
Presentation Skills,
Technical Understanding,
Verbal Communication,
Requirements Analysis,
Innovation  

Position Summary

Tesaro is a growing oncology-focused biopharmaceutical company whose passionate associates are dedicated to improving the lives of cancer patients by developing and providing safer and more effective therapeutics and supportive care products. This position will report to the Vice-President, R&D Operations and will provide tactical and operational management of program development activities for the company’s development programs. The candidate is responsible for integrating high level program deliverables into detailed operational plans for efficient execution, and is expected to work closely with internal and external resources to forecast and manage timelines, resource plans, critical path activities and risks. The Sr. Manager will partner with the VP R&D Operations to lead and manage development projects, report overall program status and issues, as well as engage in scenario planning.  The candidate will play an important role in building efficient and collaborative cross-functional planning with program stakeholders to achieve effective cross-functional planning and execution.

Responsibilities

• Manages the day-to-day operational and tactical aspects of one or more programs or projects in accordance with the development plan
• Ensures that appropriate progress is being made against defined strategies; proactively raises issues and recommendations for resolutions
• Builds operational plans for discrete projects in the plan, identifying all critical path activities and inter-linkages between activities; proactively works with consultants and others to effectively integrate the development activities cross-functionally
• As appropriate, works with program teams to build and analyze alternative and backup scenarios.
• Creates and manages detailed, integrated schedules; works with the program team to build and maintain development timelines current to evolving data and assumptions
• Regularly and proactively considers challenge points and opportunities for acceleration, and communicates to the VP R&D Operations
• Works with the VP R&D Operations to build an integrated program or project budget based on the development assumptions and timeline; supports the tracking of actuals to budget and communicates deviations to budget or prospectively identified variations
• Creates team agendas and documents meeting minutes; creates and manages content for other key PM documentation such as budget summaries, key drivers, decisions taken and program history

Education/Experience Requirements

• BS/MS in a scientific discipline
• 5+ years of experience in the biopharmaceutical industry
• 3+ years of experience leading multi-disciplinary development teams in the execution of operational plans ideally across multiple functional areas and various development phases
• Project management and leadership training (PMP certification is a plus)
• Confident, proactive individual capable of taking the initiative and driving to results; demonstrated experience managing programs to agreed timelines, within budget and within scope
• Strong understanding of overall drug development strategies, spanning across all critical product development disciplines (nonclinical, clinical, CMC, RA/QA, commercial strategy and development)
• Working knowledge of GXPs and other applicable compliance requirements
• Core competency for the application of traditional program management principles and practices
• Strong organizational skills in order to maintain a high level of productivity innovation, and setting priorities in order to complete assignments in a timely manner and within budget
• Demonstrated ability to work effectively in a team environment and foster team building and commitment to goals
• Competency in MS Office; expert in MS Project
• Some travel may be required

Seeking: Senior Software Engineer for a Synthetic Biology Start-Up

 BACKGROUND:
Gen9 is transforming synthetic biology by creating novel technologies to increase innovation within several industries including biopharmaceuticals, fine chemicals and bio-fuels.  Synthetic biology is poised to modernize trillion dollar industries by introducing genes that program microorganisms to produce pharmaceuticals, biofuels and chemicals. We are seeking a dynamic individual to contribute to the advancement of our cutting edge platform for gene synthesis.

JOB RESPONSIBILITIES:

• Design and development of platform and associated componentry for web-based applications including:
  • Design for data organization, navigation, and human interaction
  • Visualization and analysis of data
  • Collaboration with end users
• AWS cloud development
• Contribution to workflows and pipelines for production and data analysis
• Provide software tools support for research, manufacturing and production
• Code base maintenance (documentation, testing, revision control)

 REQUIRED QUALIFICATIONS:

• MS, or PhD in computer science, bioinformatics, physics, biology, or related degree
• 3+ years of industry experience preferably in a biology, genomic or biotechnology company
• 3+ years experience designing, using and developing within UNIX/Linux environments
• Demonstrated proficiency with Python
• Strong communication, documentation, and presentation skills
• Familiarity with biology is not required, but beneficial

Locale: Cambridge, MA

HOW TO APPLY:
Send resume & cover letter to:  resumes-informatics@gen9bio.com

Please briefly describe your knowledge and experience with the Required Qualifications in your cover letter/email.

 DEADLINE:
Resume review will begin February 8, 2013.

Contract Clinical Trial Manager:

Our client is a major international pharmaceutical company northwest of Boston.  Looking for solid Trial Managers / Project Managers.  Must have Oncology experience (specifically Phase I), with solid experience working in an environment where everything is outsourced to CRO's.  Great pay and initial contract length of 1 year.  

Our client, located northwest of Boston, MA is looking for an experienced CTC that can hit the ground running.  This is a contract position with an initial length of 1 year.  Oncology experience is preferred but not necessary.  Successful candidate will have solid experience coordinating large scale clinical trials.

Our client, located west of Boston is looking for an experienced SAS programmer.  Successful candidate will have 3-5 years experience with the biotech SAS programming arena.  Master's degree is preferred.  Reasonable relocation is possible for the right person.