Gaithersburg
MD
Position: * Serves as the expert in Clinical Data Management to provide support and advice to the clinical project team regarding the DM activities and deliverables to ensure effective delivery of the DM Center service. * Project related DM activities, technology and standards: o Ensure quality and consistency of DM components across therapeutic areas/programs. o Provide DM input to the development of clinical project standards and processes, including new concepts and techniques. o Ensure DM deliverables align with standards. o Provide DM and data collection expertise to study teams and development therapeutic area standards. o Provide DM business expertise and consultancy in the selection and use of software systems as appropriate. o Review project DM documentation and specifications as needed to ensure consistency with MedImmune strategies and standards. * Review, assess and manage DM Center delivery against KPIs and overall DM Center performance for studies. * Work with the DM Center, input to the production of the DM Service Order and study costs for studies being processed at the DM Center. * Ensure DM Center billing is accurate and manage invoicing process. * Initiate contract process for the database vendor and provide study team with estimated costs for hosting services. * Ensure study teams utilize standards by: o Working with study teams to understand and explain standards and escalates change requests to standards to the Standards Committee * Lead, coordinate and ensure transparency and consistency of MedImmune clinical study team and DM center activities including: o Provide the DM Center with MedImmune project planning information (scheduling of the studies, volumes, timelines etc.) o Facilitate DM related requests and issue escalation/resolution between MedImmune clinical study teams and the DM Center to meet study timeline and quality expectation o Monitor, manage and resolve escalated issues related to delays to DM Center deliverables by developing solutions to complex problems to ensure consistency across organization o Provide input to the DM related activities associated with regulatory inspections/audits * Assess MedImmune DM needs and improvement potential and recommend changes to the operating model * May be asked to provide strategic DM expertise to global Clinical Initiatives * May be asked to take on a global standards role as a member of the Standards Committee Education: * Education: University degree or equivalent experience * Minimum 6-8 years experience of working in Data Management in the Biotech/Pharma/CRO industry. * Demonstrated comprehensive knowledge and experience of most aspects of Data Management * Strong project management skills, communication skills, and interpersonal skills * Demonstrated leadership skills * Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP * Comprehensive knowledge or regulatory requirements as they relate to DM activities * Comprehensive knowledge of data standards, database structures and of capturing and storing clinical information * EDC experience strongly preferred
* Education: University degree or equivalent experience * Minimum 6-8 years experience of working in Data Management in the Biotech/Pharma/CRO industry. * Demonstrated comprehensive knowledge and experience of most aspects of Data Management * Strong project management skills, communication skills, and interpersonal skills * Demonstrated leadership skills * Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP * Comprehensive knowledge or regulatory requirements as they relate to DM activities * Comprehensive knowledge of data standards, database structures and of capturing and storing clinical information * EDC experience strongly preferred
Posted On -
5/17/2013 7:17:25 AM
Gaithersburg
MD
Position:
* Serves as the expert in Clinical Data Management to provide support and advice to the clinical project team regarding the DM activities and deliverables to ensure effective delivery of the DM Center service.
* Project related DM activities, technology and standards:
o Ensure quality and consistency of DM components across therapeutic areas/programs.
o Provide DM input to the development of clinical project standards and processes, including new concepts and techniques.
o Ensure DM deliverables align with standards.
o Provide DM and data collection expertise to study teams and development therapeutic area standards.
o Provide DM business expertise and consultancy in the selection and use of software systems as appropriate.
o Review project DM documentation and specifications as needed to ensure consistency with MedImmune strategies and standards.
* Review, assess and manage DM Center delivery against KPIs and overall DM Center performance for studies.
* Work with the DM Center, input to the production of the DM Service Order and study costs for studies being processed at the DM Center.
* Ensure DM Center billing is accurate and manage invoicing process.
* Initiate contract process for the database vendor and provide study team with estimated costs for hosting services.
* Ensure study teams utilize standards by:
o Working with study teams to understand and explain standards and escalates change requests to standards to the Standards Committee
* Lead, coordinate and ensure transparency and consistency of MedImmune clinical study team and DM center activities including:
o Provide the DM Center with MedImmune project planning information (scheduling of the studies, volumes, timelines etc.)
o Facilitate DM related requests and issue escalation/resolution between MedImmune clinical study teams and the DM Center to meet study timeline and quality expectation
o Monitor, manage and resolve escalated issues related to delays to DM Center deliverables by developing solutions to complex problems to ensure consistency across organization
o Provide input to the DM related activities associated with regulatory inspections/audits
* Assess MedImmune DM needs and improvement potential and recommend changes to the operating model
* May be asked to provide strategic DM expertise to global Clinical Initiatives
* May be asked to take on a global standards role as a member of the Standards Committee
Education:
* Education: University degree or equivalent experience
* Minimum 6-8 years experience of working in Data Management in the Biotech/Pharma/CRO industry.
* Demonstrated comprehensive knowledge and experience of most aspects of Data Management
* Strong project management skills, communication skills, and interpersonal skills
* Demonstrated leadership skills
* Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP
* Comprehensive knowledge or regulatory requirements as they relate to DM activities
* Comprehensive knowledge of data standards, database structures and of capturing and storing clinical information
* EDC experience strongly preferred
Posted On -
5/17/2013 7:17:25 AM
Gaithersburg
MD
Position:
Hands?on laboratory experience working with proteins is required. Demonstrated competency using several methods such as: HPLC, SEC, DSC, FTIR, UV?Vis, CD, fluorescence, particle counting, diafiltration
and dialysis is desired. Experience working in the biotechnology industry supporting commercialization of biopharmaceuticals is strongly desired. Candidate should be able to proactively perform work, determine technical objectives, and be an independent thinker.
Education:
MS in biochemistry, biophysical chemistry, pharmaceutical chemistry, physical chemistry, chemical engineering or a related field and 0 to 2 years of relevant experience or BS with 2 to 5 years of experience.
Posted On -
5/17/2013 7:17:25 AM
Gaithersburg
MD
Position:
Position Requirements:
* Prefer a combination of at least 3 years experience in Sales Operations supporting efforts in territory alignments, call reporting, CRM and overall analytics.
* Exceptional understanding of Microsoft Office products (Word, Excel, Outlook, Project, PowerPoint and Access) and Adobe Acrobat.
* Strong knowledge of relevant healthcare industry data/information resources.
* Strong organizational and time management skills; ability to manage diverse range of simultaneous projects.
* Strong interpersonal skills, demonstrated ability to work collaboratively with peers and customers.
* Strong proactive communication (oral/written) skills and ability to present analytics to management team.
Successful performance in this position requires an individual who is proactive, analytical, inquisitive, and can manage projects/vendors while thriving in a fast paced, team-oriented environment. The analyst should have strong verbal and written communication skills, require little supervision, and should have a solid understanding of available data sources in the bio-pharmaceutical industry. Finally, this person should know how to form relationships and ultimately have the interpersonal skills necessary to influence others without authority.
Education:
* Bachelor's Degree required
* Related experience working in Sales Operations
* Preferred Background:
o MBA or Master's degree preferred in Business Administration, Statistics, Science or other healthcare relevant disciplines
Posted On -
5/17/2013 7:17:25 AM
Gaithersburg
MD
Please note that this position may be filled at either the Senior Project Manager level or the Project Manager level. This position may be located in either our Gaithersburg, MD office or our Cambridge, UK office.
For the Senior Project manager level, we require a minimum of 8 years of Project Management experience in a BioPharma Product Development environment. For the Project Manager level, we require a minimum of 5 years of Project Management experience in a BioPharma Product Development environment.
Required Skills:
Product Development Process
? Understands overall biologic/pharmaceutical product development process, including stages of development and role of different functional areas.
? Working knowledge of the biological sciences with technical, scientific or medical expertise in one or more functional areas involved in pharmaceutical/biologic product development.
? Early and late phase clinical development stages and processes and decision criteria for moving programs through the development pipeline, and the considerations relevant to post-marketed development and life cycle management.
? Core cross-functional concepts (e.g., preclinical, translational, CMC) and major requirements at different development stages.
? Basic knowledge of worldwide regulatory requirements, processes and regulatory authority interactions, as well as patent protection and records management.
? Commercial valuation, product life cycle planning, pricing and health economics.
Project Management
? Ability to create, coordinate, and maintain an integrated product plan and to control or respond to changes in strategy and scope.
? Expertise in use of project management software solutions, including skills in critical path analysis. MS Project and/or Planisware experience is a plus.
? Understanding financial and resource planning systems and processes and ability to coordinate project-level budget/resource estimates and manage actuals vs. plan.
? Ability to manage teams and individuals in a matrix environment, ability to track team performance against objectives, use of effective meeting management tools and techniques, and knowledge of decision-making and conflict resolution techniques.
? Ability to maintain sources of project information, and to integrate and distribute appropriate information to senior management and team members.
? Able to negotiate with team members to resolve project/team issues.
Education:
? BA/BS in a biological science or equivalent work experience is required. An advanced degree (e.g., MBA, MS) is preferred.
Posted On -
5/17/2013 7:17:25 AM
Philadelphia North
PA
Position:
Judgment Requirements:
This position requires substantial individual judgment given the frequency and significance of interactions with MedImmune customers, and the seriousness associated with indications for MedImmune products. The BSS is expected to have the degree of judgment and diplomacy necessary to maintain cross-functional support. The BSS must know and always adhere to MedImmune policies and commit to doing business the right way.
Decision-making Requirements:
In this position, BSSs are expected to make broad day-to-day decisions and must, therefore, be able to make decisions that reflect and support the overall strategies of the area, region, and company. BSSs are expected to have the capacity to quickly and effectively respond to questions and unusual situations. Quality decisions, which may be made in the presence of customers, need to be based on appropriate training and personal judgment. Other key decision activities may include, but are not limited to, establishing hospital account and BSS territory objectives and tactics, prioritizing and selling to targeted customers, managing the BSS territory budget, and coordinating appropriate MedImmune and corporate partner personnel to accomplish objectives.
Initiative Requirements:
BSSs are expected to function effectively without close supervision. Therefore, it is imperative that each BSS possess a strong initiative, work ethic and be goal-oriented. BSSs should have a high degree of self-discipline and personal drive in order to focus on activities and communications that will support achievement of stated area, region, and company goals while continuing to build individual capabilities. BSSs must be self-motivated to seek out, recognize, and act upon local market opportunities central to the short-term and long-term success of the area, region, and company.
Outside:
Professional and diplomatic interaction with many levels of health and business professionals will be required.
Experience:
* A minimum of 2-3 years proven, successful sales experience in the Pharmaceutical, Biotechnology or Medical Products industry.
* Work experience in a medical setting (i.e. NICU, PICU or private physician office pediatric nursing, medical technology, respiratory therapy, physician's assistant, etc.) is beneficial but not required.
Supervision of Others:
None.
Travel Requirements:
Travel will vary by business territory. Overnight, multi-night, and/or weekend travel may be required to accomplish desired objectives. The BSS will be expected to be able to attend company meetings and use the company-mandated forms of transportation to and from those meetings.
Education:
Education and Special Skills:
* A four-year college degree, preferably in a scientific / medical or business discipline or relevant experience is required.
* Background in Managed Care, Marketing or Sales is beneficial.
Posted On -
5/17/2013 7:17:24 AM
Gaithersburg
MD
Minimum Requirement-Education and Experience
* Education: University degree in science related field; medical credentials preferred or equivalent experience.
* Minimum of 5 years coding using MedDRA and WHO Drug Dictionary and/or Clinical Data Management experience in the Biotech/Pharma/CRO industry.
* Demonstrated comprehensive knowledge and experience of most aspects of Data Management
* Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP.
* Comprehensive knowledge or regulatory requirements as they relate to Data Management and Clinical Coding activities.
* EDC experience strongly preferred.
Posted On -
5/17/2013 7:17:24 AM
Gaithersburg
MD
This requisition can be filled at either the Senior Director or the Director level. For both levels, a proven track record of industry experience in Translational and Clinical Research in drug development. For the Senior Director level we require a minimum of 13 or more years of experience including industry experience in research and development of novel therapeutics for the treatment of respiratory, inflammation and autoimmunity, or clinical immunology disease. For the Director level, we require a minimum of 10 or more years of experience including industry experience in research and development of novel therapeutics for the treatment of respiratory, inflammation and autoimmunity, or clinical immunology disease.
Special Skills/Abilities:
? Firm understanding of the mechanistic basis of human diseases in the RIA space to drive target evaluation, biomarker selection and PHC strategies
? In depth knowledge of research and clinical development of biologic therapeutics.
? Familiarity with predictive biomarkers and personalized healthcare approaches as they pertain to research and early clinical development is highly desired.
? Hands-on experience in development of in vitro and in vivo assays for clinical and research use, with the aim of assessing biomarkers for indication selection.
? Understanding and ability to develop biomarker strategies and diagnostics to evaluate successful response to treatment with monoclonal antibody.
? Familiarity with clinical protocols and regulatory processes.
? Organizational skills with attention to detail and demonstrated ability to write technical reports, biomarker protocols, perform quantitative analyses, and graph and present data.
? Outstanding verbal and written communication skills.
? Strong leadership and interpersonal skills to work and lead in a matrix team environment.
? Problem solving and organizational skills
Education:
M.D., Ph.D., M.D./Ph.D. or equivalent with at least 10 - 15 years of experience including industry experience in research and development of novel therapeutics for the treatment of respiratory, inflammation and autoimmunity, or clinical immunology disease.
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Position:
* 15 + years of bio-pharmaceutical industry experience
* 5 + years in bio-pharmaceutical Operations involving complex project delivery
* Successful professional record of collaboratively delivering complex projects
* Outstanding communicator with excellent executive level presentation skills
* Working knowledge of the units of operations of a pharmaceutical supply chain
* Understanding of CMC, bio-pharm development, and Regulatory processes
* Knowledge and understanding of supply chain design and planning concepts
* Experience in financial budgeting (CapEx, OpEx, COGM)
Education:
* Required: Bachelors degree. Sciences or Engineering preferred.
* Advanced degree: MBA or Sciences preferred.
Posted On -
5/16/2013 6:29:16 AM
Philadelphia (Non Sales)
PA
Requirements:
Has some knowledge of HR disciplines with expertise in few to none.
Executes plans to resolve moderate to complex problems.
Capable of resolving sensitive concerns that present moderate risk to the business.
Develops solutions to low to moderately complex problems.
Works under ongoing supervision. Work is reviewed for soundness of judgment and overall quality and efficiency.
Participates in the execution of objectives and goals for HR and the HR related goals of shared client groups.
Inquires, develops, interfaces and delivers relevant site HR and people management metrics.
Serves as consultant to management and employees on HR policies, programs, capabilities, and objectives.
The ideal candidate will have 4+ years of HR experience in business partner, shared services and/or will have been progressively promoted within HR to supervisory or similar independent contributor levels of leadership.
2+ years HRIS experience preferred, SAP-HR desired
2+ years of manufacturing facility experience desired
Experience working with Microsoft office products
Education:
4 year degree preferred
SHRM certification helpful
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Position:
Experience
Minimum of 5 years work experience in the biopharmaceutical industry
* Pipeline marketing experience preferred
* Experience marketing in-line brands a plus
* Experience in Respiratory, Rheumatology, Dermatology and/or related inflammatory disease areas a plus
* Scientific background a plus
* Experience with global drug development: 2+ years of pipeline marketing and/or in-line marketing experience for prescription products
* Strong understanding of drug development processes, and of the global market access and reimbursement environment
* Experience in pharmaceutical markets outside the U.S. a plus
Education:
BS or BA required; MBA preferred; additional scientific degree a plus.
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Position:
Minimum of 10 years work experience in market research in the Pharmaceutical/Biotech Industry.
Education:
4 year University degree in Business, or Biology/Chemistry/Statistics with some core business courses. MBA or equivalent business experience required
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Position:
* Minimum 5 years of biotechnology, immunology and/or biopharmaceutical industry experience, including substantial experience supporting market access initiatives to gain appropriate coverage and payment.
* Experience working with payers and decision-makers
* Experience demonstrating product value, including preparing AMCP dossiers and/or submissions to HTA agencies
? Experience making substantial contributions to commercial assessment, licensing & development, portfolio management, and lifecycle planning
? Proven analytical, strategic, negotiation, financial modeling, and relationship building skills.
Education:
? BA/BS degree in relevant health-related field required.
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Position:
Position Requirements:
* Prefer a combination of at least 5 years experience in Field Sales in Bio-Pharmaceutical Industry.
* Excellent communication skills both verbal and written which are customer focused and provide clear direction.
* Excellent presentation skills and the ability to address many different audiences.
* Excellent organizational skills and time management; ability to manage diverse range of simultaneous projects.
* Strong analytical and field insight skills
* Customer focused -- customer service with a focus on the impact that Sales and Marketing Operations processes and analytics have on our internal customers.
* Very strong proficiency of Microsoft Office products (Word, Excel, Outlook, Project, PowerPoint) and Adobe Acrobat.
* Strong knowledge of relevant healthcare industry data/information resources.
* Strong interpersonal skills, demonstrated ability to work collaboratively with peers and customers.
Successful performance in this position requires an individual who is proactive, inquisitive, and can manage projects/vendors while thriving in a fast paced, team-oriented environment. The Manager/Sr. Manager should have exemplary verbal and written communication skills, require little supervision, and should have a solid understanding of the available data sources in the Bio-Pharmaceutical Industry. Provide field perspective to the analytics and insight SFE delivers to the field. Develop clear concise communications that provide clear understanding and aligned with the SFE vision. Finally, this person should know how to form relationships and ultimately have the interpersonal skills necessary to influence others without authority.
Education:
* Bachelor's Degree required
* Field Sales experience (Field Sales Leadership experience preferred)
* Preferred Background:
o MBA or Master's degree preferred in Business Administration, Science or other healthcare relevant disciplines
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
This position can be filled at either the Senior Patent Agent level or the Counsel level. For the Senior Patent Agent level, we require that candidates are currently a U.S. Registered Patent Agent with a minimum of 5 years of patent related experience including experience writing and prosecuting patent applications. Law firm or a combination of Law Firm and Corporate experience is strongly preferred. In addition, for the Counsel role, we require candidates to have a J.D. from an accredited law school and membership in the bar of at least one U.S. state or the District of Columbia.
Education:
Ph.D. or equivalent is preferred in the areas of Molecular Biology, Immunology, Biochemistry, Biology, Virology or equivalent, but will consider an M.S. with significant research experience.
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Position:
Knowledge: The candidate should have in-depth understanding and multiple years of experience with a wide application of technical principles, theories, and current concepts in investigative and toxicologic pathology. General knowledge of other related disciplines such as toxicology and laboratory animal medicine is also required.
The Senior Pathologist / Principal Pathologist will be recognized by the greater pharmaceutical and pathology arenas as a leader in his/her area of specialization (investigational, IHC, toxicologic pathology) via book chapter authorship, published, peer reviewed, research or position papers, and/or editorship of recognized journals in pathology. Invited speaker to national/international meetings is also considered a form of recognition by the greater pathology world. Significant experience in image analysis would be considered an advantage.
Experience: Senior Pathologist / Principal Pathologist will have the depth of knowledge from 5 to 15 years of experience in conducting investigative and/or toxicology studies with minimal scientific/technical support from other pathologists.
Education:
Education: A D.V.M. degree from an accredited veterinary/ school and certification in pathology by a world-recognized examination board. A Ph.D. or investigative pathology experience is highly desirable.
Posted On -
5/16/2013 6:29:16 AM
Frederick
MD
Position:
At least 7 years of experience with electrical systems.
This person must have a working knowledge for operation and maintenance of medium voltage switch gear, power distribution panels, and circuit breaker panels. This person must be able to troubleshoot electrical motors of various types, troubleshoot and configure VFDs. Knowledge of PLCs is required for the control and monitoring of the electrical system. This person must be able to operate the BMS (Building Management system) to monitor power usage in the building.
Education:
Minimum of a BS degree in Engineering (preferred Electrical Engineering).
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Please note this position can be filled at either the Senior Principal Statistician level or the Principal Statistician level.
For the Senior Principal Statistician level, we require a minimum 4 years of industry experience in a clinical study environment as a lead study statistician. Experience as a lead statistician at compound level (preferred). Experience in oncology clinical trial (preferred).
For the Principal Statistician level, we require a minimum of 2 years of industry experience in a clinical study environment as a lead study statistician. Experience in oncology clinical trial (preferred).
Education:
MS or PhD in statistics or other related field with high statistical content
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Please note this position can be filled at either the Senior Principal Statistician level or the Principal Statistician level.
For the Senior Principal Statistician level, we require a minimum 4 years of industry experience in a clinical study environment as a lead study statistician. Experience as a lead statistician at compound level (preferred). Experience in oncology clinical trial (preferred).
For the Principal Statistician level, we require a minimum of 2 years of industry experience in a clinical study environment as a lead study statistician. Experience in oncology clinical trial (preferred).
Education:
MS or PhD in statistics or other related field with high statistical content
Education:
Education: MS or PhD in statistics or other related field with high statistical content
Posted On -
5/16/2013 6:29:16 AM
Gaithersburg
MD
Education: Ph.D. in Chemistry, Biochemistry, or equivalent required.
Experience: Must have 7 or more years of experience in a biopharmaceutical company with relevant experience in Biophysical characterization which includes structure-stability assessments using a variety of methods (e.g., spectroscopic, chromatographic, mass spectrometric, etc.). Led method development, optimization, troubleshooting & tech transfer activities. Experience managing multiple direct reports is required.
Posted On -
5/16/2013 6:29:16 AM
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