Click here for details on how to get further information, or how to apply for any of the positions listed. List updated on 6/22/04.

Director, Clinical Research, Cardiovascular #04-007
Manager, Regulatory Affairs #03-053
Associate Director, Clinical Research #04-006
Clinical Hospital Specialist
#04-038 NY, NY (south of Manhattan)
#04-039 Mobile, AL (Pensacola, Montgomery)
#04-040 Portland, OR
#04-041 San Antonio, TX
#04-042 Evanston, IN (Southern Illinois)
#04-046 Columbus, OH
GCP Quality Systems Specialist #04-024
Senior Scientist- Toxicology #04-025
Manager of Drug Safety #04-032
Medical Science Liaison- Great Lakes #04-034
GMP Auditor #04-043
Research Associate- Organic Synthesis #04-044
Part Time Mailroom Clerk #04-052
Scientist, Formulations #04-056


Director, Clinical Research, Cardiovascular
Reference number: 04-007

Mission:
Provides strategic direction and management for the evolution of the Cardiovascular area in a growing pharmaceutical development organization. This individual will provide medical leadership and management of clinical research and drug development programs. The successful candidate will possess extraordinary leadership competencies and the strategic business perspective needed to bring products forward and to maximize their commercial value.

Scope of Responsibility:
Responsible for developing strategies and solving problems across diverse functional areas of the business, e.g. clinical medicine, clinical operations, biostatistics, data management, regulatory affairs, and marketing. Precision and timeliness of decisions will have a long-term impact on the company's success. Designs global clinical development plans to achieve optimal speed, quality, and results; collaborates with academic thought leaders and maintains excellent working relationships with technical consultants; manages the interactions with regulatory authorities; and oversees the interpretation and reporting of clinical study results. Additionally, they will negotiate important and difficult policy-making matters with internal and external executive-level management.

This position reports to the SVP of Development.

Qualifications:
Requires MD degree with board certification in Cardiology and a minimum of 2 years pharmaceutical industry experience in clinical drug development (Phase 3 and 4).

The successful candidate must have a fundamental knowledge of GCP, FDA Regulations and ICH guidelines, possess excellent communication and negotiation skills, and have the ability to work effectively with individuals in all levels and functions.

A demonstrated willingness to take initiative and become directly involved in planning, problem solving and execution of work in a team environment is critical. Knowledge of drug development in hospital based products or in the field of Oncology is desirable.

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Manager, Regulatory Affairs
Reference number: 03-053

Department: Regulatory Affairs

Qualifications/Experience:
Education: A Bachelors/Masters degree in a scientific discipline or equivalent is highly desirable.

Experience: Exercise independent judgement within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. A minimum of 3 to 8 years related experience, including the preparation, review and filing of INDs/NDAs and other regulatory submissions. Experience with clinical issues and GCPs required. Experience with pharmacology/toxicology and/or CMC, desirable. NDA experience, a plus. May determine methods and procedures on new assignments and may provide guidance or supervision to other lower-level personnel. Will be responsible for at least one product in clinical development and will work in a team approach with contributing functions.

Brief Description:
  • Coordinate the preparation, review and submission of regulatory documents that are complete, properly formatted and in compliance with local regulations.
  • Review documentation from departments outside regulatory affairs to ensure quality and completeness for submission to regulatory agencies.
  • Implement regulatory strategies to address global product development, CMC, labeling or promotional issues; recommend regulatory strategies to RA Team Leader, Team Members and/or supervisor, as appropriate.
  • Interact on a limited basis with regulatory personnel (EMEA, FDA, HPFB, etc.) as appropriate, and with the knowledge and close supervision of the supervisor, for assigned projects.
  • Prepare interpretive analyses of key regulatory guidance documents, regulations, or directives that impact Guilford products and operations.
  • Participates on RA teams or committees, as needed.

Types of submissions worked on primarily include: Preparing, reviewing portions of an IND and NDA, protocol amendments (Phases I, II, & III), information amendments, IND annual reports, 7- and 15-day safety alerts, and product labeling.

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Associate Director, Clinical Research
Reference number: 04-006

Department:
Clinical Affairs

Brief Description:
Independently design and report clinical trials (Phases I, II, and III) within a clinical program. Work closely with DM/PK and biostatistics to ensure proper design and endpoints, such that the clinical trials are well executed and study objectives are attained. As a team leader you will provide strategic leadership for your team such that the team completes corporate objectives on time and within budget.

Qualifications/Experience:
Education: Advanced degree (MD, PhD/MD) and a minimum of 2 years experience in clinical development at a biotech or pharmaceutical company involving Phase II and Phase III clinical trials.

Experience:
  • Background in clinical science and pharmacokinetics.
  • Background in CNS product development is a plus.
  • Proficient with MS Office computer software.
  • Excellent written and verbal communication skills.
  • Experience in writing clinical documents such as protocols, IBs, and clinical study reports.
  • Ability to function well in a team environment.
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Clinical Hospital Specialist
Reference number: 04-038 NY, NY (south of Manhattan)
Reference number: 04-039 Mobile, AL (Pensacola, Montgomery)
Reference number: 04-040 Portland, OR
Reference number: 04-041 San Antonio, TX
Reference number: 04-042 Evanston, IN (Southern Illinois)
Reference number: 04-046 Columbus, OH


Department:
Sales & Marketing

Qualifications/Experience:
Education: BS in life sciences preferred.

Experience: Minimum 3 to 5 years pharmaceutical sales experience with a hospital specialty product. Overall experience will therefore, typically be 6 to 8 years minimum in the pharmaceutical industry.

The ideal candidate will possess:
  • Sales experience in the operating room/surgical setting calling on Neurosurgeons and/or Interventional Cardiologists in the cardiac cath. lab.
  • Demonstrated success in utilizing clinical reprints/studies in the selling process.
  • Willingness to travel extensively in the respective territory and calling on hospitals, neurosurgeons, neuro oncologists and cardiologists.
  • Proven track record of success in all previous sales positions
Brief Description:
As a Clinical Hospital Specialist you will have the opportunity to present clinical information and education to leading physicians in the cardiology, neurosurgery and neuro-oncology specialty. You will be responsible for achieving sales budgets and marketing Guilford Pharmaceuticals products through credible and dependable education of healthcare professionals, clinical support staff and pharmacists. In addition to a competitive compensation program we will provide an outstanding corporate support network through our Medical Affairs and Marketing Teams.

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GCP Quality Systems Specialist

Reference number: 04-024

Department:

Clinical/ Preclinical Compliance

Qualifications/Experience:
Technical
  • Good Clinical Practice (GCP) regulation knowledge
  • Proven Quality Systems Documentation knowledge
Management
  • Strong organizational skills and attention to detail
  • Strong interpersonal and communication skills
  • Demonstrated experience working with study director(s)/ principle investigations and contractor personnel to ensure adherence to protocols, SOPs and regulations/guidelines
  • Ability to promote a positive team-oriented interaction between departments.
Must be able to travel for company business regularly, up to 50% time

Education:
B.S. in relevant area with between two and five years of experience in a regulated pharmaceutical setting with a minimum of two years of that time spent doing GCP quality auditing.
Brief Description: The GCP Quality Systems Specialist is responsible for maintaining the quality assurance programs that ensure regulatory compliance. This includes conducting internal and external audits, including audits of Contract Research Organizations, Investigator Sites, Clinical Study Reports, and Trial Master Files to ensure clinical trials are conducted in compliance with current Good Clinical Practices. Additional responsibilities for maintenance of the Quality Assurance and Quality Control systems for GCP, will require;
  • Review and approval, as necessary, for protocols, amendments, standard operating procedures and additional documentation
  • Providing regulatory guidance and on-going GCP training to Clinical Operations staff
  • Review of current changes in GCP regulations and incorporation of these changes into the GPI quality system
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Senior Scientist- Toxicology

Reference number: 04-025

Department: Toxicology

Brief Description:

To assess the safety profile of biopharmaceutical products for the purpose of bringing these therapies forward to proof of principle in clinical evaluation and to provide support for the further clinical development of these products.

Primary Duties and Responsibilities:

  • Initiating, designing and implementing safety protocols
  • Writing and editing safety profiles for submission
  • Initiate, contract and maintain relationships with CROs and vendors
Qualifications/Experience:

Technical
  • Ph.D. in toxicology or related field and/or DVM and GLP experience
  • Expertise in general toxicology is a plus
  • American Board of Toxicology certification is desirable
Management
  • Interactions with CROs
  • Superior written and verbal communication skills are essential
  • Requires ability to organize data, conduct accurate and detailed examination of written materials, and to work as part of a multi-disiplinary team
  • Expert familiarity with current GLP regulations
Educational Requirements:

  • Ph.D. and/or DVM with 5-10 years of toxicology minimum experience
  • 2 to 5 years experience in the pharmaceutical industry, providing support for drug development
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Manager of Drug Safety

Reference number: 04-032

Brief Description: Guilford Pharmaceuticals is seeking an experienced professional in drug safety to direct and be responsible for the function of a clinical safety/ pharmacovigilance group for both marketed drugs and drugs in development; to work closely with the Regulatory function to collect, interpret and generate clinical safety segment of world-wide regulatory reports relating to the safety of marketed drugs and drugs in development.
This individual will report to the Director of Clinical Operations and interact with Clinical Research, Medical Affairs and Regulatory Affairs teams.
Primary Duties and Responsibilities:
  • Monitors all safety reports and responds accordingly.
  • Maintains the safety database.
  • Communicates medical/safety information responses via prepared written summaries and/or verbal communication.
  • Serves as a resource that provides timely medical, scientific, and technical information to inquiries regarding all investigational drug products.
  • Ensures completeness of responses and that information is communicated professionally.

Qualifications/Experience:

Education: Advanced degree in Medical Science or related area with a minimum of 3 years of pharmacovigilance experience.

Experience:
  • Experience in pharmacovigilance, writing SOPs, managing safety databases.
  • Experience in providing leadership, finding creative solutions, and understanding of Code of Federal Regulations pertaining to Drug Safety.
  • Ability to interact with other departments to achieve goals in demanding environments
  • Excellent computer skills and familiarity with ARISg databases are required.
  • Excellent written and interpersonal communication skills at a professional medical level, as well as the ability to manage outside contractors/ consultants.
  • Excellent customer service management skills and the ability to complete tasks in a timely fashion in a fast-paced, high-pressure/stress environment.
  • Ability to work independently and possesses strong organizational skills.
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Medical Science Liaison- Great Lakes

Reference number: 04-034

Department:
Medical Affairs

Brief Description:
Guilford Pharmaceuticals is seeking an experienced professional in medical affairs to provide medical information and education to our field sales team and to assist their efforts by disseminating timely and accurate product knowledge through presentations and lectures.

This individual will report to the Senior Director of Medical Affairs and will interact as a member of the regional business unit. He/She will work closely with and will be supported by the directors of medical affairs to meet the needs of the field sales force.

Primary Duties and Responsibilities:
  • The MSL will coordinate and facilitate the Grant-in-Aid program (investigator-initiated phase IV trials) for the assigned region. This will be accomplished by evaluating and making funding recommendations for study proposals, as well as working with investigators to facilitate completion of data analysis and publication of study reports.
  • Responsible for maintaining clinical and technical expertise regarding Guilford’s marketed products. This will allow the MSL to review marketing/exhibition material, to identify/cultivate thought leaders and potential product advocates, and to engage in discussions at scientific meetings and professional forums.
Experience:
  • Excellent interpersonal skills.
  • Ability to interact with physicians/healthcare professionals, as well as the field sales force, in an effective and professional manner
Education:
  • Pharm D, RN or PA with a minimum of 2 years industry experience in a liaison role.
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Senior Clinical Research Associate

Reference number: 04-035

Department:
Clinical Research

Brief Description:
To ensure that developing products are properly tested in clinical trials according to good clinical practices and international conference of harmonization regulations using sound scientific principles. To further ensure that data obtained from these studies is obtained in a timely manner and is of a quality to meet global regulatory approval requirements for product approval.

Primary Duties and Responsibilities:
This position requires a willingness and ability to travel up to 40%. The person fulfilling this role should be able to perform with minimal supervision while demonstrating interpersonal and problem solving skills. Additionally, the CRA role requires the skill to provide clear and diplomatic direction and guidance to GPI colleagues, vendors and all site personnel and investigators.

Qualifications

Education:
B.S. or higher in a science related field or equivalent.

Experience:
  • Three to five years of experience as a CRA, monitoring and training for clinical trials in support of drug development.
  • Must have knowledge of GCP/ICH guidelines and the scientific background necessary to review and interpret data.
  • Must be computer literate with a proficiency in word processing.
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GMP Auditor

Reference number: # 04-043

Department:
Quality Assurance

Job description:
This position will manage and execute the commercial GMP audit program. Internal and external audits will be the primary responsibility of this position, along with the management of the Product Complaint and Returned Goods handling systems.

Essential Functions of the Position:
Manage the commercial GMP Audit System to ensure compliance with Guilford Pharmaceuticals SOP’s. Identify compliance issues and ensure quick and appropriate resolution. Schedule, plan, and perform internal and external GMP audits Manage the product complaint handling system to ensure thorough review of all complaints and ensure quick closeout. Manage the returned goods system to ensure full accountability for all products returned and destroyed. Write audit reports and audit summaries for senior management, applying and providing guidance on quality-related regulations and guidelines, and SOPs Assist in the development of internal quality systems

Qualifications:
BS in a biological science with a minimum of 8 to 10 years experience in Quality Assurance for pharmaceutical industry, which includes a minimum of 4 years performing GMP audits. Must possess high-level of professionalism and demonstrate the use of sound judgment and diplomacy when communicating sensitive information

Strong communication skills (both oral and written) in order to effectively conduct audits and communicate results to both internal and external customers.

Approximately 50% travel

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Research Associate- Organic Synthesis

Reference number: # 04-044

Department:
Research Chemistry

Brief Description:
This individual will be responsible for the design, synthesis, purification, and characterization of small organic molecules for our drug discovery programs under the direction of a senior team member.

Primary Duties and Responsibilities:
  • Synthesizing, purifying and characterizing small organic molecules
  • Assisting new drug design and SAR studies
Qualifications/Experience:
Technical

Must be proficient in design, synthesis, purification, and characterization of small organic molecules for drug discovery programs. Familiar with purification methods (Flash chromatography and recrystallization) and use of analytical instrumentation such as NMR, HPLC, UV, MS, etc for characterization.
  • strong problem?solving aptitude
  • excellent interpersonal and communication skills
  • demonstrated ability to work constructively as a member of a multiple disciplinary project team are essential
Educational Requirements:
Minimum of three years industrial experience with BS/BA or no experience with MS/MA

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Part Time Mailroom Clerk

Reference number: # 04-052

Department:
Executive/ Mailroom

Qualifications/Experience:

Position requires a cooperative attitude, reliability and attention to detail.

Education: H.S. diploma

Brief Description:

The expedition of the delivery and pick up of the US postal mail and interoffice mail
  • Organize all elements in preparation to do an efficient job.
  • Maintain log book for certified/registered mail
  • Sort all mail by department and individual in preparation for delivery.
  • Provide full coverage for mailroom during absences of full time mail clerk
  • Distributes sorted mail to its perspective receiver
  • Maintain pleasant, helpful attitude
  • Provide information on the most efficient way of mailing international, priority, express, certified return receipt mail
  • Ensures proper postage is affixed to outgoing mail


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Scientist, Formulations

Reference number: 04-056

Department:
Pharmaceutics

Brief Description:
This individual will conceptualize, design, direct and execute pharmaceutical product development strategies and activities both internally and externally. They will apply formulation and process development skills to the development of viable dosage forms of new chemical entities for clinical studies and participate in pre-formulation development. Additionally, they will apply characterization expertise to support the selection of potential clinical candidates, advance quality drug formulations into clinical development and commercialization in a timely manner.

Primary Duties and Responsibilities:
  • Recommends and manages strategic outsourcing options for formulation developmental activities to accelerate pharmaceutics development timeline
  • Recommends, develops and prepares prototype dosage forms to be used as clinical trial supply for NCEs
  • Recommends, evaluates and demonstrates feasibility of manufacturing processes for selected prototypes.
  • Ensures the compliance with Regulatory, cGMP and GLP regulations as well as lab safety practices
  • Participates in the drug characterization program for clinical development of NCEs and outsourcing activities related to preformulation.
  • Identifies and supports opportunities for invention disclosure and patent applications on scientific work
  • Solicits and facilitates efforts of cross-functional groups to ensure timely completion of pharmaceutical development objectives.
  • Ensures that GPI is using state of the art technologies by exploring alternative dosage forms, manufacturing technologies and maintains competitive product knowledge.
  • Ensures critical scientific data for LPS is available in timely fashion
  • Determines physicochemical properties, stability, solubility estimation, preliminary drug characterization and toxicological formulation at LPS stage
  • Contributes to the preparation of the pharmaceutics activity outline, timeline and the report for LPS
  • Develops formulations for animals studies at discovery stage

Experience (skills/knowledge/ability):
  • Strong technical knowledge in the field of pharmaceutical pre-formulation, formulation and production of solid dosage forms
  • Significant prior experience contracting/outsourcing formulations development, clinical trials supply manufacture and process development activities and/or work experience with a contract manufacturing organization
  • Independent, self-motivated performer with significant research project management skills
  • Thorough knowledge of cGMP and manufacture of Clinical Trial Supplies
  • Strong verbal, written and listening skills
  • Strategic thinking and planning skills
  • Works well across functional areas and be a team player
  • Licensed practicing Pharmacist will be an added advantage

Education:
BS/MS – in Pharmacy, Chemical Engineering or Physical and Chemical Sciences with 7-10 years experience and a solid record of scientific achievement and performance in all previous levels

Ph.D. with 7+ years industry experience in Pharmaceutical formulations

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How to Apply for a Position at Guilford
To apply for any of the positions listed, please send your resume and a letter including the position reference number to:

E-mail - hr@guilfordpharm.com
Please Note: Due to virus issues, we are not currently accepting zip files as e-mail attachments.

Manager, Staffing
Reference Number
Guilford Pharmaceuticals Inc.
6611 Tributary Street
Baltimore, MD 21224


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Guilford Pharmaceuticals Inc. is an Equal Employment Opportunity Employer, and invites applications for employment from all qualified persons without regard to race, color, religion, sex, national origin, disability, status as a special disabled veteran or veteran of the Vietnam Era, marital status, or any other factor prohibited by law.


This page was last updated on Tuesday, June 22, 2004

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