MindPharm is partnering with a Baltimore City based Outpatient Mental Health Clinic to identify a skilled Psychiatrist to provide mental health services to children, adolescents and families.

Job Description
Outpatient Mental Health Clinic seeking a Child & Adolescent Psychiatrist to provide services at their Baltimore City and Harford County locations.

Requirements: Candidates must have experience working with Children and Adolescents. Also, must be knowledgeable with the regulations of the (COMAR).

Key Responsibilities include: Conduct Psychiatric Evaluations to new clients, Provide medication monitoring and possible therapy to clients as needed. Participate in weekly treatment team meetings every Tuesday at 10:00 am to discuss clients and provide recommendations on treatment. Oversee clinical and crisis management and assures service delivery and compliance with all regulatory, contractual, corporate and legal requirements.

Medical staff must be able to work in a high demanding atmosphere, be energetic, client friendly, reliable and well organized.

Skills/ Requirements

• Candidates must have a Degree in Psychiatry with a minimum of 3 years working with Children and Adolescents.
• Also, must be knowledgeable with the regulations of Outpatient Mental Health Program and must be knowledgeable with DSM-IV diagnosis.
• Candidates must have excellent communicative, written and leadership skills.
• Must have excellent computer skills, be familiar with Value Options and must be proficient in MS Word.
• Criminal background check required.
  
  For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

MindPharm is partnering with a large, Clinical Research Organization to identify candidates for an exciting opportunity to lead Medical Monitoring of global Phase I studies.

Location: Maryland

The successful candidate will develop clinical study protocols, review and interpret clinical study data; develop clinical study reports and other applicable documents; serve as Medical Monitor, ensure the accuracy and quality of sponsor deliverables, and of all relevant Clinical Research and Development (CRD) and IDS activities, and compliance with ethical, legal, scientific, regulatory and client standards.
Roles & Responsibilities:

• Serve as Scientific Team Leader and/or Clinical R&D team member on multidisciplinary project teams
• Provide expertise and leadership in early phase drug development and regulatory science on project specific issues, including study design and data interpretation
• Serve as the medical monitor for clinical studies
• Review and interpret data and analyses from clinical studies, including raw data files, summary tables, figures and listings
• Write, review, edit and QC applicable documents, including client proposals, synopses, protocols, amendments, case report forms, study reports, narratives, investigator brochures, informed consent forms, adverse event/concomitant medication coding, data validation specifications, manuscripts, clinical development plans and statistical analysis plans, that meet scientific and regulatory standards as applicable
• Oversee, participate or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review or other study-related meetings
• Prepare and participate in scientific and capability presentations for prospective clients (Business Development, Bid Defense) and for presenting at conferences and professional meetings. Collaborate with Business Development on client identification and development for new projects.
• Participate in and/or lead process improvement initiatives such as establishing and improving document standards, process mapping & documentation, SOP authoring, review and revision, gap analysis and resolution of department training plans & SOPs or other procedures
• Participate and assist management in defining and managing applicable cost models, project timelines and budgets, and improve efficiencies of processes with respect to quality, cost and time
• Contribute to the CRD resource library (eRoom), including relevant literature, example documents, style guides and templates
• Resolve issues and escalate problems as necessary
• Undertake other reasonably related duties as may be assigned from time to time.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (~10%) domestic and/or international

Experience & Qualifications:

• MD/DO, board certified in a primary medical specialty (internal medicine, pediatrics, family practice) is preferred. Clinical Pharmacology training a strong plus.
• A minimum of 2 years of relevant experience in clinical pharmacology, early (phase 1-2a) clinical drug development, early phase clinical research, regulatory science and preparing applicable clinical research documentation.
• Knowledge of scientific and regulatory requirements applicable to early phase clinical studies
• Excellent written and verbal communication skills, clinical data-interpretation skills, strong interpersonal and leadership skills, ability to plan/organize and multi-task.
• Excellent computer skills to include MS Word, Excel, PowerPoint

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

MindPharm is partnering with a large, diversified BioPharmaceutical company to identify candidates for an exciting opportunity to join the Process Engineering Team and to advance new oncology therapeutics into the clinic.

Location: MidWest
Department: Research Division Global Pharmaceutical R&D

Position Description:

Process Engineers in the company's Global Pharmaceutical R&D work in multi-functional teams to develop scalable processes and supply API for safety testing, clinical trials and formulation development.  The teams include Process Chemistry, Pilot Plant Operations, Analytical Chemistry and others.  Process Engineers support API projects through all phases of development (Phase I to Process Validation).  Early in development engineers concentrate on ensuring the process can be run safely, identifying and addressing major scale-up issues and developing the final (API) process step.  Later in development process engineers optimize all aspects of the entire API process.  Engineers lead process campaigns run in the R&D Pilot Plant.  In the final stage of development, engineers transfer the optimized process to manufacturing and support process validation.

Process Engineers should possess the following skills / experience;

• Strong lab skills focused on optimization of unit operations such as reactions, distillations, extractions, membrane separations, chromatography, crystallization, centrifugation, filtration, drying and milling.
• The incumbent would be expected to work with automated reactors (250ml to 20 liters), small-scale glassware and other scale-up test equipment
• A technical background in kinetics, thermodynamics, fluid mechanics, mass transfer, and heat transfer
• Ability to perform simulation/modeling using Aspen or comparable software
• Ability to perform analysis using standard techniques such as HPLC, GC, NMR, microscopy, and titration
• The incumbent would also be expected to work with on-line analytical techniques such as IR, Raman, laser reflectance or defraction particle sizing and MS
• Good verbal and written communication skills
• The ability to analyze extensive data sets and communicate a summary of their analysis effectively.
• The ability to interact well with diverse groups within R&D.
• Engineers will be expected to maintain strong working relationships with internal and external collaborators
• A basic understanding of government regulation such as FDA cGMPs, EPA hazardous waste regulations, local and federal environmental regulations, and OSHA chemical hygiene plans
• Experience transferring a scaled-up process to commercial facilities.

Minimum qualifcations - (BS/MS/PhD) in chemical engineering with 0 - 3 years experience and demonstrated records of strong accomplishment

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

MindPharm is partnering with a large, Clinical Research Organization to identify candidates for an exciting opportunity to lead Phase I Medical Writing and assist in Medical monitoring of  global Phase I studies.

Location: Maryland

The successful candidate will assist the Medical Monitor in communications between clinical study site and project staff regarding protocol questions;

• assist with the review and interpretation of clinical study data; writing, editing, compiling and QC of documents;
• ensuring the accuracy and quality of applicable written deliverables, and of scientific and clinical research, review, and medical monitoring activities, and compliance with ethical, legal, scientific, regulatory and client standards.
• assist in managing and executing the daily operational and strategic activities in Clinical Research and Development

Role & Responsibility:

• Assist the Medical Monitor in communications between study site, Client Company project staff, and sponsors regarding protocol or other study-related questions, including documenting, tracking, following-up on all issues
• Assist the Medical Monitor in the review, analysis and interpretation of data from clinical studies, including data files, tables, figures and listings
• Assist the Medical Monitor in the writing, review, editing and QC of applicable documents, including proposals, synopses, protocols, amendments, reports, narratives, investigator brochures, informed consent forms, case report forms, data validation specifications, manuscripts, clinical development plans and analysis plans, ensuring that they meet scientific and regulatory standards as applicable
• Insure proper version control of all applicable documents
• Oversee or assist in the planning and conduct of DSMB, Safety Review Committee, Cohort Review, Dose Escalation, Data Review or other study-related meetings
• Assist in preparing scientific, process and capability presentations for prospective clients (Business Development, Bid Defense) and for presenting at conferences and professional meetings
• Participate in and/or lead process improvement initiatives such as establishing and improving document standards, process mapping & documentation, SOP authoring, review and revision, gap analysis and resolution of department training plans & SOPs or other procedures
• Participate and assist management in defining and managing applicable cost models, project timelines and budgets, and improve efficiencies of processes with respect to quality, cost and time
• Define, collect, track and report on metrics and KPIs
• Assist in growing and managing the CRD resource library (eRoom), including relevant literature, example documents, style guides and templates
• Resolve issues and escalate problems as necessary
• Undertake other reasonably related duties as may be assigned from time to time.
• Recognize, exemplify and adhere to Client Company's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Travel (10%) domestic and/or international

Experience & Qualification:

• BS/BA in a biomedical science plus additional medical and/or relevant scientific education. Advanced degree (Masters, PhD, MD, or local equivalent) a strong plus
• Minimum of 4 years of relevant experience in early clinical drug development, clinical pharmacology, clinical research, regulatory science and preparing applicable clinical research documentation in a pharmaceutical company and/or CRO environment.
• Knowledge of scientific and regulatory requirements applicable to early phase clinical studies
• Excellent written and verbal communication skills, clinical data-interpretation skills, strong interpersonal and leadership skills, ability to independently plan, organize, prioritize and multi-task in a fast-paced environment.
• Excellent computer skills to include MS Word, Excel, PowerPoint, Visio; scientific graphing (e.g. SigmaPlot, Origin, Prism, Patient Profiles) a plus

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

MindPharm is partnering with a large, diversified Pharmaceutical company to identify candidates for an exciting opportunity to lead clinical research in Oncology.

Location: North East, CT
Department: Oncology

Scope of position:

• Directs the design, development and execution of clinical drug development plans, protocols and related activities.
• Assures that protocols will adhere to standard clinical practices and company SOPs.
• Designs protocols and secures the conditions essential for safety and efficacy evaluations of a new drug candidate.
• Recommends new approaches to data analysis in collaboration with functional experts in R&D such as Operation, Biostatistics, Pharmacovigilance and Regulatory Affairs.
• Organizes meetings to discuss critical issues, such as safety and efficacy.
• Develops staff of physicians, scientists, and coordinators by providing expertise and guidance. Participates in Project Development Teams.

Qualifications/ Education Requirements:

• MD with five years plus of drug development experience.
• Preferred board certification in oncology and/or hematology.
• Experience working in matrix teams, has demonstrated leadership and originality in problem solving as applied to drug development.
• Preferred experience in dealing with health authorities in the US and abroad.

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

MindPharm is partnering with a large, diversified BioPharmaceutical company to identify candidates for an exciting opportunity to join the Global Pharmaceutical R&D Quality Assurance team.

Location: MidWest
Department: Research Division Global Pharmaceutical R&D

Position Description:

• Partcipates in activities of PV Compliance function within GPRD Quality Assurance (QA) independently with minimal oversight
• Provides support and consultation to other business partners with regards to PV compliance issues
• Assures that company is in a continuous state of PV compliance with company policies and procedures and country specific and other applicable standards and worldwide regulations by continuously evaluating PV processes
• Plans, conducts and resolves PV audits worldwide as required
• Collaborates with business partners and other GxP functions to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings
• Participates in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements including management review and continuous improvement processe
• Actively participates in and supports PV inspections or remotely helps to make PV inspections a success and supports resolution of findings by working with PV business partners
• Promotes continuous education on PV regulations for self and other staff
• Ensures development / continuous improvement and implementation of necessary PV systems to ensure compliance to worldwide regulations and QR policies.
• Generates, analyzes and reports PV compliance metrics do demonstrate key aspects of the PV compliance status
• Demonstrates accountability and responsibility for Environmental Health and Safety (EHS) performance and compliance through active participation and support of company’s EHS Programme.

Experience Requirements

• Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner
• Detailed knowledge of auditing standards
• Extensive knowledge of worldwide PV regulatory requirements and industry best practices
• Flexibility to adapt to changing assignments and ability to effectively prioritize
• Project management, interpersonal, and communication skills and ability to work independently and as part of a team
• Willingness and ability to perform international travel up to 40%.

Education Requirements: Bachelors Degree or equivalent
Percent of Travel: 20 - 50 %

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

 

 

MindPharm is partnering with a large, diversified BioPharmaceutical company to identify candidates for an exciting opportunity to join the Tumor Biology Team and to advance new oncology therapeutics into the clinic.
 
Location: MidWest
Department: Research Division Global Pharmaceutical R&D

Position Description:
Seeking an individual to join the tumor biology team to conduct histopathological evaluation of IHC studies and general oversight of histotechnicians in the areas of tissue processing, sectioning and immunohistochemical staining procedures.
Candidate will;

• Guide the method development of antibodies for target expression and biomarker analysis in both FFPE and OCT whole sections and TMAs;
• Summarize IHC results and prepare presentations and interact with cross-functional teams to support IHC needs for different programs.
• Possess the ability to drive the strategy for translational biomarker development, coordinate and establish both internal and external collaborations, develop new methodologies to support multiple small molecule and biologics programs is essential.
• Have knowledge in the areas of cancer biology, adaption of IHC and development of translational IHC biomarker assays for use in the clinic is desired.

 
Qualifications:

• 5-8 years experience in oncology R&D experience within the pharmaceutical industry, academia or equivalent
• Must have 3+ years experience in IHC, antibody selection and optimization of IHC protocols (FFPE and OCT)
• Strong pathology background required and digital pathology experience with relevant cancer biology research background and clinical pathology experience is highly preferred
• Board certification is highly desired
• Candidate with proven leadership skills, strong research and industry experience, good interpersonal skills, ability to direct or lead technical studies, strong communication (excellent verbal and written skills) and teamwork skills are required.

Requirements:
PhD and/or MD or DVM in a relevant field + 2-3 years experience in IHC

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

 

 

MindPharm is partnering with an established BioPharmaceutical company to identify candidates for  the in vitro Biology Cancer Research group to augment  the discovery and development of innovative treatments to help patients in the fight against cancer.

We are currently seeking a highly motivated cell biologist to join our Cancer Biology group within the Cancer Research Division. The incumbent will be expected to identify and validate novel cancer targets as well as develop biochemical and cellular assays to support lead discovery and optimization. The individual must be able to prioritize and manage multiple research activities. Experience in DNA metabolism (repair/replication), apoptosis, cell cycle and/or other signal transduction pathways related to oncogenesis is essential.
The grade level will be commensurate of the individual's experience.

Major responsibilities:
Independently guide the development of novel target candidates; develop and maintain appropriate in vitro assays to guide SAR studies; interact with cross-functional teams to facilitate lead advancement; critically evaluate relevant scientific data and apply this knowledge to research efforts; contribute substantially to the overall research strategies; continually implement and validate novel research approaches to advance project goals; communicate results to multi-disciplinary teams; publish project-related research in peer-reviewed journals.Skills/Experience
 
RequirementsSkills/Experience:

• Ph.D. in Cell Biology or related discipline with 3 years post-graduate experience in the area of cancer is required.

• Demonstrated scientific achievements, i.e., strong publication and/or patent record.
• Proficiency in standard biochemical, cellular and molecular techniques are highly preferred.
• Strong communication and teamwork skills are essential.
•  

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

 MindPharm is partnering with a large, diversified BioPharmaceutical company to identify candidates for an exciting opportunity to join the Quality Assurance team and to lead vendor compliance fro Global R&D.

Location: MidWest
Department: QA

Job Description:

• Assure that GPRD remains in compliance with Corporate and Divisional policies and procedures and all applicable worldwide regulations
• Provide consultation and assistance to GPRD personnel on compliance issues.
• Provide GPRD personnel with training on applicable worldwide regulations.
  Lead cross-functional project teams to help identify potential issues and resolve current issues.
• Manage compliance issues in Global Project Team/Functional Area programs, escalating issues to GPRD QA management as appropriate
• Responsible for GCP vendor management activities including vendor qualification, performance and ongoing performance monitoring through onsite auditing, metrics and KPI assessments.
  

Major Responsibilities:

• Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures
• Plan, organize, and lead multiple audits of R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally
• Evaluate the potential risk of compliance deficiencies across protocols and/or compounds within assigned Therapeutic Area/Program, utilizing tools such as metrics and trending of audit findings, and communicate compliance risks to GPRD QA management
• Identify services, maintain audit schedule, plan, organize and lead audits of external contract facilities (specialty testing laboratories, central laboratories, clinical sites, central Institutions, Review Boards (IRBs), Contract Research Organizations (CRO) and distributors as applicable) both within the US and globally
• Communicate Contract Research Organization (CRO) status to GPRD QA management, follow up on ongoing Corrective Action Plans with Suppliers and participate in strategic initiatives involving CROs
• Maintain effective communication of program related information
• Review corrective action plans/audit responses for adequacy and approve if adequate
• Review policies and procedures and suggest improvements
• Create quality/compliance training programs for the GPRD organization
• Identify, initiate, manage, and/or participate in quality improvement projects
• Work independently as well as a team
• Mentor, coach and train QA auditing staff
• Prepare and present multiple project progress reports to update management and keep the team(s) informed
• Maintain project oversight to include assessments for the development program, allocation of QA resources and awareness of project timelines
• Supervise Quality team members for project specific activities as required.
  Directly coordinate GPRD GCP Compliance auditing programs
• Assist with the definition of GPRD Quality Goals.
  
  
  Accoutability and Scope:
  This position is accountable to the Director of GCP Compliance, GPRD QA. The decisions and recommendations made by the individual will directly impact compliance to applicable regulations, and thereby promote the continued success of GPRD. These activities such as auditing and associated functions can have a great impact on the quality of the data, which can, ultimately, lead to delay, or inability of company to market new products.

Skills/Experience Requirements:
The job requires knowledge of quality principles, research, and the development of pharmaceuticals and an understanding of the effect of his/her decisions on it.

The individual must be able to:

• Work independently, in a team environment, and with all levels of personnel within the organization
• Effectively handle multiple assignments simultaneously
• Anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall program
• Demonstrate a thorough knowledge of the applicable regulations and be able to apply them to a wide variety of situations
• Successfully interact with all levels of personnel within the division
• Show initiative to identify and implement new approaches to resolve problems (i.e., risk assessments, CAPA plans)
• Proactively identify issues across protocols and/or compounds;
  · Utilize innovation in solving problems.
  
  Must be able to make decisions with limited supervision, but decisions may be discussed with GPRD QA Management prior to implementation of action plan.

Education Requirements:
Bachelor’s Degree in a physical science, life science, nursing, pharmacy or equivalent experience required.

For consideration please contact;

Stephanie Miller

MindPharm, LLC

www.mindpharm.net

410-448-4522

stephanie.miller@mindpharm.net

A cure for the common cold may finally be achieved as a result of a remarkable discovery in a Cambridge laboratory

By Steve Connor, Science Editor

Tuesday, 2 November 2010

Finding ways to enhance the activity of specific bacteria in the colon is the tricky part of the puzzle, but the discovery is an interesting one.

Discovery May Help Scientists Boost Broccoli's Cancer-Fighting Power - FierceBiotech

ScienceDaily (Oct. 22, 2010) - A University of Illinois study has shown for the first time that sulforaphane, the powerful cancer-fighting agent in broccoli, can be released from its parent compound by bacteria in the lower gut and absorbed into the body.

"This discovery raises the possibility that we will be able to enhance the activity of these bacteria in the colon, increasing broccoli's cancer-preventive power," said Elizabeth Jeffery, a U of I professor of human nutrition.

Sea snail venom has been previously used to make an injection for pain, but this formulation has a much wider range of potential applications, including peripheral neuropathy.  

Sea snail saliva may become new treatment for most severe pain

Scientists have developed a new version of a medication, first isolated from the saliva of sea snails, that could be taken in pill form to relieve the most severe forms of pain as effectively as morphine but without risking addiction. An article on the topic appears in the current issue of Chemical & Engineering News

This article covers the advances being made in individualized (patient-specific) cancer vaccines as well as the science behind them.  Most of this generation of vaccines will be used following radiation and chemotherapy to clear residual cancer cells  from the body, but the potential exists for future vaccines that would replace chemo entirely.

New Cancer Vaccine Kills Lymphoma, Now in Phase III Clinical Trials | Singularity Hub

Accentia Biopharmaceuticals and Biovest International have developed a non-Hodgkin?s lymphoma (NHL) vaccine that teaches the body?s immune system to identify and destroy tumor cells while leaving healthy tissue intact. The vaccine, called BiovaxID, is already in Phase III clinical trials.

Autopsy results have confirmed that scans performed using the dye while the patient was still alive map the distribution of plaques in the brain.  The dye is currently in clinical trials by Pfizer, Eli Lilly, and Bristol-Myers


Squibb,

Brain dye can spot Alzheimer's - FierceBiomarkers

A study has found that researchers can detect Alzheimer's disease with a brain scan using radioactive dye called AV-45 or florbetapir, which was developed by Philadelphia-based Avid Radiopharmaceuticals.

No recommendations are being made until there is independent confirmation, but the results are encouraging.

Fish Oil May Reduce Risk of Breast Cancer

Researchers at the Fred Hutchinson Cancer Research Center in Seattle, Wash., led by Emily White, Ph.D., a member of the public health sciences division, asked 35,016 postmenopausal women who did not have a history of breast cancer to complete a 24-page questionnaire about their use of non-vitamin, non-mineral ?specialty? supplements in the Vitamins and Lifestyle (VITAL) cohort study.

After six years of follow-up, 880 cases of breast cancer were identified using the Surveillance, Epidemiology and End Results registry.

Regular use of fish oil supplements, which contain high levels of the omega-3 fatty acids, EPA and DHA, was linked with a 32 percent reduced risk of breast cancer. The reduction in risk appeared to be restricted to invasive ductal breast cancer, the most common type of the disease.