Senior Clinical Research Scientist - Pharmacology
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for Oncology, CNS,and Infectious Disease with facilities in Bergen Co., New Jersey. The following position is a unique role supporting the Clinical Research Department with expertise in Clinical Pharmacology.
Location: North Central New Jersey, Bergen, Co.
Reports to: Director Clinical Pharmacology
Department: Clinical Pharmacology
Job Description:
The Senior Clinical Pharmacology Research Scientist (SrCPRS) will independently plan, design, direct, execute and summarize assigned clinical pharmacology department clinical studies, with minimal oversight from senior Clinical Pharmacology Department (CPD) staff. The SrCPRS will work closely with, and direct the operations staff on studies for which the SrCPRS is responsible. The SrCPRS will be responsible for the development of long range plans and budgets for studies they are assigned, and they will develop new methodologies to explore clinical pharmacology aspects of select compounds. The SrCPRS will be a member of relevant Clinical Teams. The SrCPRS will be involved in the preparation of regulatory documents (e.g. NDA documents, investigators brochures, etc.). The SrCPRS will develop working practice documents and will independently develop relevant formal training programs.
Plan, design and direct clinical pharmacology department studies in various therapeutic categories, under the oversight of senior CPD staff.
Function as a study director for assigned studies.
Direct the activities of monitors assigned to clinical studies with regard to: (1) protocol and CRF design; (2) identify qualified clinical investigators; (3) negotiate clinical study budgets; (4) regular monitoring activities; (5) verifying data; (6) handling clinical supplies and (7) interacting with BCDM and PKDM.
Independently develop long range plans and budgets for assigned studies, under the oversight of senior CPD staff.
Ensure that all assigned studies are conducted according to GCPs, relevant SOPs, and Department WPDs.
Job Qualifications:
5 years of experience in clinical research in the pharmaceutical industry
Requires a Doctoral (PharmD or PhD) level degree (or in some cases a Masters Degree)
A thorough understanding of clinical research methodology including study design, protocol writing and CRF preparation is required as is a knowledge of GCP and local regulatory requirements.
Working knowledge of the IND/NDA process acquired through direct industrial experience is required.
Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area.
For consideration please contact;
Stephanie Miller,
MindPharm, LLC,
www.mindpharm.net,
410-448-4522,
stephanie.miller@mindpharm.net
Researchers at North Carolina State University have discovered that
adding tiny bits of gold to a failed HIV drug rekindle the drug's
ability to stop the virus from invading the body?s immune system.
Failed HIV drug gets second chance with addition of gold nanoparticlesThe drug, a compound known as TAK-779, was originally found to bind to a specific location on human T-cells, which blocks the HIV virus? entry to the body?s immune system. Unfortunately, the portion of the drug?s molecule that made binding possible had unpleasant side effects.
Posted by Stephanie at 01:53 PM. Filed under: Science
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Senior Research Scientist / Research Scientist Formulations Development
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for chronic pain. With facilities in Central New Jersey the following position will have the opportunity to develop novel modified release formulations and participate in new product development.
Department: Pharmaceutical Formulation Development
Reporting to:
Group Leader Formulation Development
Position Responsibilities:
The candidate will be responsible for developing modified release formulations for NDA filings. This development will be conducted under tight timelines through different phases of clinical development and the candidate will be required to interact with multiple functions.
Develop robust and stable formulations for new products. Utilize experimental design for formulation optimization
Conduct pre-formulation activities. Characterize physical and chemical properties of formulated products
Work with technical operations to develop, optimize and scale up manufacturing processes.
Perform clinical batch manufacturing of new products in compliance with cGMP requirements
Document experiments in notebooks, maintain samples and records, author scientific reports and present to management
Prepare CMC documentation for NDA filings
Follow and write SOP?s
Review of latest scientific and patent literature
Requirements:
Masters degree in Pharmaceutical Sciences (Ph.D. preferred)
Significant solid oral formulation expertise with knowledge of scale-up, specifically in multiparticulate technologies
Hands on experience in equipment operation, especially Wurster fluid bed
Demonstrate effective time management to meet aggressive timelines
Excellent written and oral communication skills
Work independently with minimal supervision
Strong team player and ability to interact with multiple disciplines
For consideration please contact; Stephanie Miller
MindPharm, LLC
www.mindpharm.net
410-448-4522
stephanie.miller@mindpharm.net
Senior Director/Director Clinical Pharmacology(Translational Medicine)
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for Gastrointestinal, Oncology and Cardiac care. The following position will lead the Proof of Concept Decision making for early stage development programs.
Location: North Central New Jersey, Bergen, Co.
Reports to: Executive Vice President
Department: Clinical Development/ Research
Position Description:
Contributing to the drug development process by serving a leadership role on IPT's in:
Job Qualifications:
For consideration please contact;
Stephanie Miller,
MindPharm, LLC,
www.mindpharm.net,
410-448-4522,
stephanie.miller@mindpharm.net
Group Leader/Principal Scientist/ Associate Director
MindPharm is partnering with a leader in pre-clinical behavioral neurobiology and a provider of customized and innovative solutions for central nervous system (CNS) drug discovery. Our client works with pharmaceutical and biotechnology companies, academic institutions and not-for-profit research foundations to address such major neurological disorders as: ALS, Huntington?s Disease, anxiety, cognitive impairment, depression, psychosis/schizophrenia and SMA.
We are seeking a highly motivated, enthusiastic and focused individual to join the Cognitive Neuroscience Group.
Location: Tarrytown, NY
Reports to: Head of Cognitive Neuroscience
Department: Cognitive Neuroscience
Position Description:
This team of highly motivate and talented PhD?s and Research scientists currently consists of three teams; Contract Cognitive Research, Experimental Cognition and the Neurodegeneration Cognition Group.
The successful candidate would lead the Neurodegeneration Cognition Group. Supervising a highly motivated and growing team consisting of PhD and Research scientists. The candidate would lead a group focused on murine based models of neurodegeneration with emphasis on identifying the emergence of disease phenotype of motor and cognition deficits, disease progression, attenuation and survival. This position will interface directly with clients, supervising the Target Validation of novel compounds and targets aimed at bringing novel and much needed symptomatic and disease modifying therapies for Huntingdon?s and Alzheimer?s disease.
Required Skills and Experience:
The candidate would possess knowledge and/or experience with animal models of neurodegenereation (e.g Huntingdon?s and Alzheimer?s disease) with emphasis on cortical - striatal interactions and medial temporal lobe function.
The candidate would be required to demonstrate a strong work ethic and promote scientific curiosity and innovation within the department. To keep on top of recent advances within the literature and champion new and improved procedures into the department in order to broaden understanding of discipline relevant to the group's goals.
A large emphasis is placed on excellent communication and interpersonal skills.
Educational Background:
The minimum requirement of this position is a PhD in Cognitive/Behavioral Neuroscience, Behavioral Pharmacology or a similar discipline.
Experience:
Minimum of 2-3 years post-doctoral research experience, management experience preferred
For consideration please contact;
Stephanie Miller
MindPharm, LLC
www.mindpharm.net
410-448-4522
stephanie.miller@mindpharm.net
Director, Regulatory Affairs Non-Clinical
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for Oncology, CNS,and Infectious Disease with facilities in Bergen Co., New Jersey. The following position is a unique role supporting the Regulatory Affairs Group with expertise in Pre-clinical Development.
Location: North Central New Jersey, Bergen, Co.
Reports to: VP Regulatory Affairs
Department: Regulatory Affairs
Job Description:
Contribute to development results by providing regulatory leadership & assume a supervisory and/or "subject matter expert" role with regard to regulatory issues.
Support regulatory strategy & contribute to its outcome within the Nonclinical area
Advise management & recommend departmental operating procedures/policies to accomplish work more efficiently & with better quality control
Define regulatory vision & strategy for achieving that vision and engages and motivates team to buy into vision and execute strategy
Job Qualifications:
DVM/ PhD with strong Pharmacology/ Toxicology experience
Regulatory expertise within non-clinical testing and pre-clinical development together with a broad understanding & experience in DMPK/ ADME evaluation as well as a thorough understanding of the drug development process
Experience with direct interaction with the appropriate regulatory bodies
Must possess in-depth knowledge of appropriate Code of Federal Regulations & Regulatory Guidance Documents
History of working in complex team environments with numerous/diverse stakeholders
For consideration please contact;
Stephanie Miller,
MindPharm, LLC,
www.mindpharm.net,
410-448-4522,
stephanie.miller@mindpharm.net
Clinical Pharmacy Unit Manager
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for chronic pain. With facilities in Central New Jersey the following position will have the opportunity to build and lead the Clinical Pharmacy and supply chain activities.
Department:
Formulation Development
Location:
Piscataway, NJ
Reporting to:
Director Formulation Development
Description:
Manages and coordinates activities relating to the clinical trial supply-chain (including GMP material storage, inventory and distribution processes, label generation, packaging and labeling operations, and the use of GMP packaging areas) to support technical and clinical development programs, assuring that all activities are completed at high level of quality in conformance with Federal regulations.
Experience:
BS/MS in Sci. or Engineering
5 to 10 years of experience in pharmaceutical development or pharmaceutical supply-chain management
In depth knowledge and training in cGMPs
Demonstrated knowledge in Clinical Trial Supply packaging, labeling and distribution
Excellent oral and written communication skills in combination with strong interpersonal skills
Ability to work with other functional groups internally and at contractors
Experience managing third party contract organizations
Position Responsibilities:
CLINICAL TRIAL SUPPLIES (CTS) INVENTORY AND SUPPLY CHAIN MANAGEMENT
Manage the clinical GMP inventory system and retain sample inventory system.
Manage the CTS supply-chain in close coordination with Formulation Development (FD) and Clinical Development (CD) including the development and implementation of distribution plans.
Manage sampling and sample distribution of supplies from clinical GMP inventory. Coordinate with clinical sites for return of CTS. Manage reconciliation and disposal of returned goods and components.
CLINICAL PACKAGING DESIGN
Work with CD to determine the optimal packaging configuration for CTS.
Determine and develop optimal shipping configuration to maintain product label storage conditions during shipment. May work with CMOs to develop packaging configurations.
CLINICAL LABEL DESIGN
Manage clinical label design and approval in close collaboration with CD, Regulatory Affairs (RA) and Compliance and Quality Assurance (C&QA).
Procure or produce labels for clinical product shipments and ensures C&QA release of labels where appropriate.
PACKAGING AND LABELING MANAGEMENT
Manage external contractors for the packaging, labeling and distribution of CTS for projects in all phases of clinical development.
Identify and participate in the selection process of CMOs and develop strong working relationships with those CMOs for CTS packaging, labeling and distribution.
Manage CMOs for the packaging, labeling, distribution and returning of CTS.
PACKAGING AND LABELING OPERATION
Maintain and schedule the usage of the clinical GMP packaging and labeling rooms. Coordinate with FD, CD, facilities and C&QA to prioritize preventive maintenance, calibration and project activities.
Manage internal GMP packaging and labeling procedures at the Piscataway facility.
Purchase and maintain inventory of raw materials, components, supplies, and equipment to support ongoing activities in the clinical GMP packaging and labeling areas.
Contribute to the creation of quality system documents including development reports, SOP?s, and batch records, validation protocols and other GMP documents.
OTHERS
For consideration please contact;
Stephanie Miller
MindPharm, LLC
www.mindpharm.net
410-448-4522
stephanie.miller@mindpharm.net
Associate Director, Regulatory Affairs Oncology
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for Oncology, CNS,and Infectious Disease with facilities in Bergen Co., New Jersey.
Location: North Central New Jersey, Bergen, Co.
Reports to: Sr. Director Regulatory Affairs
Department: Regulatory Affairs
Job Description:
Support regulatory strategy & contribute to its outcome within the Oncology area
Advise management & recommend departmental operating procedures/policies to accomplish work more efficiently & with better quality control
Define regulatory vision & strategy for achieving that vision and engages and motivates team to buy into vision and execute strategy
Contribute to development results by providing regulatory leadership & assume a supervisory and/or "subject matter expert" role with regard to regulatory issues
Job Qualifications:
Regulatory expertise within clinical trial management, manufacturing, non-clinical testing and/or marketed products together with broad understanding & experience in the clinical development process within in an Oncology development program
MD, JD, Pharm. D. or Ph.D. in the life sciences highly desired, BS degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology or Pharmacology)
10-12 years of regulatory experience plus 2-3 years of additional related experience (i.e., manufacturing, clinical marketed products, etc.) preferably including some broader industry experience.
Must have experience in interacting with the appropriate regulatory bodies
Must possess in-depth knowledge of appropriate Code of Federal Regulations & Regulatory Guidance Documents
History of working in complex team environments with numerous/diverse stakeholders
For consideration please contact;
Stephanie Miller,
MindPharm, LLC,
www.mindpharm.net,
410-448-4522,
stephanie.miller@mindpharm.net
Associate Director/Director, Global Outsourcing
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for Gastrointestinal, Oncology and Cardiac care. The following position will lead the Global Outsourcing decision making for Clinical Development.
Department: Clinical Development/Research
Location: Ridgefield Park, NJ
Job Description:
In collaboration with the functional departmental heads, the incumbent will prepare a comprehensive listing of the research outsourcing marketplace & an evaluation of these service providers for each area and/or phase of operations (e.g., biostatistics, data management, Phase I-III studies, regulatory expertise, etc.)
Other responsibilities include:
Developing relationships with preferred providers (technical service providers, CRO's, clinical site consultants, etc.)
Leveraging company outsourcing requirements for superior service, quality & pricing
Supporting optimal sourcing decision-making through timely & appropriate identification of issues & documentation of joint decisions
Leading relationship management efforts to facilitate communication, drive dispute resolution with mutually beneficial outcomes & deliver continuous provider improvement results for EGC & provide internal communication of key alliance issues to Senior Management
Developing standard systems & protocols to monitor, manage & assess the quality of outsourcing relationships & maintain
Providing assistance for outsourcing process improvement, including the RFP process, change order process, start-up process, and Lessons-Learned processes.
Job Qualifications:
BA/BS in scientific discipline or a BA/BS in business with international experience required. Advanced degree preferred
Minimum 10-12 years relevant experience in the pharmaceutical industry/CRO environment is essential
Sound knowledge of entire drug development process
Expert understanding of the pharmaceutical industry/outsourcing marketplace
Extensive knowledge of vendor qualification process and vendor performance metrics
History of working in complex team environments with numerous / diverse stakeholders
Expertise in managing relationships and interfacing with outsourcers as an articulate communicator with strong negotiation skills
Must be highly organized and extremely detail oriented, great team player that works well in fast-paced, collaborative situations
For consideration please contact;
Stephanie Miller,
MindPharm, LLC,
www.mindpharm.net,
410-448-4522,
stephanie.miller@mindpharm.net
UK cancer researchers describe a unique protein tag on dendritic cells that can be used in a vaccine therapy in the Journal of Clinical Investigation.
Scientists find new cancer vaccine target - London News"We have now found a tag on dendritic cells ? called DNGR-1 ? which can be targeted by vaccines.
"Vaccines will carry a sample of the offending molecule and deliver it to DNGR-1 on the dendritic cells. The dendritic cell in turn will present the molecule to the armies of T cells and instruct them to attack."
Posted by Stephanie at 11:54 AM. Filed under: Science
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Associate Director, Clinical Regulatory Affairs
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for chronic pain. With facilities in Central New Jersey the following position will have the opportunity to build and lead a team of dedicated Regulatory Associates to support the company's clinical issues and regulatory strategy.
Location: Central New Jersey
Reports to: Director Regulatory Affairs
BASIC FUNCTION
The Associate Director acts as the initial regulatory resource for clinical development activities on assigned projects, providing functional area leadership to the team and managing the project activities of other regulatory staff assigned to projects under their authority.
JOB RESPONSIBILITIES
Responsible for organizing regulatory submission teams and coordinating the editing and preparation of clinical module or clinical content of regulatory submissions, (e.g., INDs, NDAs, annual reports, IND amendments, NDA supplements, routine correspondence)
REQUIRED SKILLS
Experienced in support of teams responsible for the preparation, and submission of INDs, CTAs and amendments, annual reports, and clinical and periodic safety reports
For consideration please contact;
Stephanie Miller
MindPharm, LLC
www.mindpharm.net
410-448-4522
stephanie.miller@mindpharm.net
Alligator blood may put the bite on antibiotic-resistant infections 
In collaboration with Kermit Murray and Lancia Darville, both of Louisiana State University in Baton Rouge, Merchant and colleagues collected blood samples from American alligators. They then isolated disease-fighting white blood cells (leucocytes) and extracted the active proteins from those cells. In laboratory tests, tiny amounts of these protein extracts killed a wide range of bacteria, including MRSA (methicillin-resistant Staphylococcus aureus), the deadly bacteria that are moving out of health care settings and into the community. These ?superbugs? are increasingly resistant to multiple antibiotics and cause thousands of deaths each year. The proteins also killed six out of eight different strains of Candida albicans, the researchers say. Their previous research also suggests that blood proteins may help fight HIV, the virus that causes AIDS.
Posted by Stephanie at 09:14 AM. Filed under: Science
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Senior Pharmacovigilance Associate
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for chronic pain. With facilities in Central New Jersey the following position will have the opportunity contribute to the Medical Affairs Team and to learn and grow cross-functionally in tightly-knit medical affairs group.
Location: Central New Jersey
Reports to: Director, Medical Affairs
Position Description:
Provide experienced support to mandatory safety reporting requirements and other functions of the Pharmacovigilance Group.
Included in these functions: adverse event case quality verification; creation of ad-hoc periodic reports; submission of reports to regulatory authorities; compilation of aggregated reports and adjunct support of medical information needs
Primarily working with outsourcing firm in facilitating the management of adverse events, product complaints, and medical inquiries.
Responsibilities:
Work with outsourcing firm on reconciliation and management of drug safety and medical information databases
Independently evaluate adverse event reports for content and completeness and assess for regulatory reportability, identify safety signals and provide data analyses and summaries
Independently make decisions and provide guidance to project teams and work on complex problems where analysis of situations or data requires an in-depth evaluation of various factors, including CRF review and assisting in establishing rules for clarity of standard SAE reporting procedures, and will assist in responding to queries from health authorities or outside sources.
Manage and facilitate medical information modules
Prepare NDA Safety Reports, management of outsourced safety handling processes.
Ensure an accurate and comprehensive safety profile of all company products and investigational compounds
Manage and process adverse events to the required FDA and ICH standards and submit them to the regulatory agencies within the agreed/stated timelines
Familiarity with ARISg safety and medical information databases
Knowledge of standard case processing methods, including authoring patient narratives and adverse event coding in MedDRA Dictionary
Review of safety reports for completeness, accuracy and appropriateness for expedited and periodic reporting
Set-up and maintenance of project files and central safety files
Initiate query generation in ARISg and staging databases
Provide independent QC of AE reports for other members of the group or external safety vendors
Attend and present on adverse event reporting to management meetings if needed
Participate in project teams and assist in their training about adverse event reporting
Assist in the training of new employees concerning adverse event reporting
Preparation of instructions and SOPs for the completion of adverse event forms
Any other duties as assigned by management
Requirements, Skills and Abilities:
Minimum 3 to 5 years in pharmacovigilance and/or medical information management.
Experience with preparation of investigational and post-marketing regulatory safety reports.
Knowledge of FDA and ICH ADE safety reporting regulations per guidelines and the ability to interpret and apply applicable regulations to resolve issues.
Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with applicable regulations.
Proficiency with standard office skills, standard desktop computing programs, basic customer service principles, medical terminology and relational databases.
Excellent oral and written communication skills with a pleasant phone personality for communications.
Excellent interpersonal skills and willingness to work in a team environment.
Demonstrates consistent attention to detail.
Highly organized and demonstrates understanding of workflow prioritization.
For consideration please contact;
Stephanie Miller
MindPharm, LLC
www.mindpharm.net
410-448-4522
stephanie.miller@mindpharm.net
Director, Medical Affairs
MindPharm is partnering with a rapidly growing Pharmaceutical company focused on drug development for urological health and oncology. The following position will have the opportunity to build and lead a team of dedicated Regional Medical Scientists and associates.
Reports to: CMO
Position Summary:
This individual will oversee and lead in developing effective business relationships, sharing vital clinical concepts and discussing new and innovative data with key thoughts leaders, investigators, potential speakers and KOL?s. The Director, Medical Affairs will oversee and manage patient recruitment, enrollment and retention in all current and future clinical studies through effective scientific and clinical presentations. The Director of Medical Affairs will participate in the development and submission of regulatory documents including summary reports, IND?s, and NDA?s. The Director, Medical Affairs is responsible for managing and will oversee the functions of the Regional Medical Scientist?s (RMS).
Core Responsibilities:
Manager and coordinate with Clinical Trial Managers in the identification of new potential healthcare professionals
Responsible for communications between clinical sites, CTM and monitors
Organize expert panel meetings and input on selected topics
Oversee in the selection of key thought leaders, advocates and potential speaker
Attend major State and National Urology and Oncology meetings to meet with key thought leaders, advocates, investigators and potential speakers
Initiate, plan and develop projects and lead teams of scientists to address relevant scientific questions
Oversee dissemination of scientific information and coordinate all educational / CME activities
Preferred Qualifications:
Ability to interpret, summarize, and convey information from clinical studies
Effective communicator and public speaker; excellent written and verbal presentation skills
Ability to work as part of a team, in both a leadership role and as a contributing member of the company
Strong interpersonal skills and the ability to work with both peers and subordinates
Compensation:
The salary and benefit package will be very attractive and highly competitive with prevailing market standards.
For consideration please contact;
Stephanie Miller
MindPharm, LLC
www.mindpharm.net
410-448-4522
stephanie.miller@mindpharm.net
ASQ's BioMedical Division will be presenting a
two-day conference entitled "
Regulators and Regulations - Who's being protected and how?" from March 27 to March 28, 2008 at the
Hilton Old Town Alexandria, Alexandria, VA. For more information follow this link to the ASQ website,
http://tinyurl.com/ystpvy
Posted by Stephanie at 07:26 AM. Filed under: Science
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