Medical Director, Oncology
Job Code: MD-O/CB
We are seeking an
independent, highly motivated individual who desires an opportunity to excel
in a team environment and make key contributions as a member of the medical
research department in a fast-paced biotechnology company focusing on
oncology.
Responsibilities
Responsibilities will
include working with the medical team to plan and conduct clinical trials of
novel anti-tumor agents, which involves meeting with prospective
investigators, providing medical expertise to protocol design, overseeing
trial start-up activities, evaluating trial progress, reviewing trial data and
maintaining contact with the investigators and trial sites. In addition,
responsibilities will include to: (1) serve as a key member of program
development teams by providing input to program plans, (2) present trial
results both inside and outside the company, (3) provide appropriate medical
monitoring of key efficacy/safety parameters, (4) assist and/or oversee the
preparation of interim and final clinical study reports as well as
investigator brochures, (5) prepare material for regulatory agencies and (6)
effectively collaborate with colleagues in related project team departments
such as Regulatory, Quality Assurance, Manufacturing, Bioanalytical and
Discovery. This position has responsibility for and oversight of the
activities involved in the successful implementation of medical projects.
Job Description
As a key member of
the medical research team, you will participate in the gamut of activities
involved in the preparation for and implementation of clinical trials as well
as provide medical input to cross-functional teams. You will plan, implement,
evaluate and interpret clinical research on investigational products. In
addition, you will be expected to provide medical expertise and clinical
judgment to all aspects of a drug development program.
You will have the
exciting opportunity to contribute substantially to the successful
implementation of Phase 1 and 2 clinical trials with the lead candidate at
ARIAD as well as additional programs as appropriate, and will report directly
to the Chief Medical Officer.
Requirements
The successful
candidate must be an MD or MD/PhD with full subspecialty training in
oncology/hematology, and have either a minimum of two years of
biotechnology/pharmaceutical work experience after completion of training, or
exceptional qualification for the position, such as relevant experience during
training. An exceptional individual with a PhD, extensive expertise in
oncology/hematology and greater number of years of experience may be
considered. Effective oral and written communication skills are required, as
are excellent interpersonal skills with demonstrated ability to work in a team
environment as well as independently, and thrive in a fast-paced environment.
Previous industry, pharmaceutical, or regulatory experience, or outstanding
academic achievement in a related field will be considered. Travel time is
approximately 20% including visits to investigative sites and attendance at
major oncology meetings.
Clinical Data Manager
Job Code: CDM-RL
Job description
As a key member of
the medical research team, the Clinical Data Manager is responsible for
providing data management expertise for assigned clinical trials. The CDM will
work closely with internal and external team members, including CROs, to
ensure quality, consistency and completeness of clinical data, as well as
timely and accurate reporting to regulatory authorities. The ideal candidate
will be able to assist in the development of an internal Data Management
department.
Responsibilities
The Clinical Data
Manager is responsible for overall data management activities of assigned
clinical trials, including:
-
Oversee data management
activities performed by CROs.
-
Review CRFs for completeness and
database considerations.
-
Review Database specifications.
-
Review and Management of Data
Quality Plans.
-
Perform data review periodically
for quality issues and general data trends.
-
Perform SAE review between CRF
data and safety database.
-
Oversee the management of non-CRF
data for file format and timelines.
-
Provide insight into the
creation of standard tables, standard field names, a library of standard
CRFs, and a core set of data quality checks.
-
Identify content to be included
in the design of CRFs
-
Develop trial specific CRF
completion guidelines.
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Prepare [or learn to prepare]
exploratory ad hoc reports for clinical group.
-
Assist in the development of
internal policies and procedures including SOPs, guidelines, data management
specific forms and documents.
-
Ensure adequate filing and
archiving of relevant data and documentation.
-
Assist in the planning and
preparation of performing data management tasks in-house.
-
Provide ongoing feedback on DM
workflows and technologies to increase efficiency.
-
Understand and follow SOPs.
-
Work effectively as a team
player with Biometrics and Clinical staff.
-
Obtain familiarity with relevant
clinical topics and issues.
Technical Skills
-
Proficient computer skills,
including use of MS office products.
-
Knowledge of data management
systems, database design and database concepts.
-
Experience with SAS, SQL,
PageMaker, FileMaker Pro, and Access are preferable but not required.
Requirements
Registered Nurse,
Pharmacist, or a Bachelor of Science degree in health related field or
equivalent. A minimum of four years experience in clinical data management in
the pharmaceutical/biotechnology industry is required, with knowledge of
medical terminology and coding dictionaries (MedDRA, WHO Drug). Past CRO
experience is preferred but not required. The successful candidate will have
strong communication and organizational skills, be detail oriented, and able
to handle multiple projects in a fast-paced work environment.
Clinical Trial Manager / Sr. Clinical Trial Manager - Oncology
Job Code: CTM-RL
Job Description
As a key member of
the medical research team, you will participate in the gamut of activities
involved in the preparation for and implementation of clinical trials. These
activities include: (1) contributions to the development and preparation of
clinical documents [e.g., protocols, informed consent, amendments, etc.], (2)
clinical site interactions [including site monitoring, enrollment tracking,
clinical trial material and clinical supply requests] in conjunction with the
CRO, (3) interactions with the CRO at team meetings and independently to
follow-up on observations, (4) interactions with other ARIAD departments
including Regulatory, Quality Assurance, Bioanalytical and Discovery, (5)
participation in development team meetings, (6) contribution to program plans,
(7) review and comment on clinical trial data, and (8) clinical trial and
regulatory document tracking.
This position
provides an opportunity to contribute substantially to the successful
implementation Oncology trials with the lead product candidates at ARIAD. In
addition, there is an opportunity to build skills in the science of clinical
research as well as oncology through day-to-day activities and close
interactions with the medical research group, formal training and
participation in oncology meetings where clinical trial data are presented.
There is an opportunity for growing responsibility and activities commensurate
with the individual's enthusiasm and eagerness to learn.
Responsibilities
The clinical trial
manager is responsible for the development and management of assigned clinical
trials, including:
-
Preparation and review of
protocols, amendments, consent forms, case report forms, and other trial
related documents.
-
Management of external vendors,
including CROs and specialty laboratories.
-
Review of site visit reports and
safety documents.
-
Co-monitoring activities at
clinical study sites and laboratories to assure adherence to good clinical
and laboratory practices, S.O.P.'s, protocols, and contractual
specifications.
-
Preparation and management of
study budgets.
-
Preparation of clinical portions
of regulatory documents as required
-
Participation in clinical trial
listing reviews.
-
Preparation and review of
clinical study reports
Additional
responsibility will be to track administrative and regulatory documents
pertaining to the investigative sites. The successful candidate also will
interact closely with the CRO providing site monitoring and management
services as well as the clinical sites participating in the clinical trials.
Technical Skills
Knowledge and
understanding of the clinical trial process and GCP/ICH is mandatory.
Proficiency with computer software such as Word, Powerpoint, Excel, and
Microsoft Project is desired, however training will be provided as needed.
Requirements
This position
requires at least a BS in Chemistry, Biology or a health-care-related field.
Job position and title will be commensurate with experience. A minimum of 2
years of clinical research experience required. The qualified candidate will
possess proficient oral and written communication skills, and be
detail-oriented with strong organizational abilities. Additional attributes
include an ability to multi-task, be flexible, and to thrive in a fast-paced
environment. Excellent interpersonal skills, with a demonstrated ability to
work in a team environment as well as independently, are required. Must be
able to travel (mostly domestic, 25 - 30%). This travel includes site visits
as well as participation in major Oncology meetings where clinical data are
presented.
Manager, Clinical Operations - Oncology
Job Code: MCO-RL
We are seeking an
independent, highly motivated individual with extensive clinical
operations/management experience who desires an opportunity to make key
contributions as a member of the medical research department in a fast-paced
biotechnology company focusing on oncology.
Job Description
As a key member of
the medical research team, you will participate in the gamut of activities
involved in the preparation for and implementation of clinical trials as well
as provide input to cross-functional teams. As outlined above, you will be
expected to manage and coordinate the operational aspects of a drug
development program. The successful candidate will effectively collaborate
with colleagues in related project team departments such as Regulatory,
Quality Assurance, Manufacturing, Bioanalytical and Discovery.
You will have the
exciting opportunity to contribute substantially to the successful
implementation of all phases of clinical trials with the lead candidate at
ARIAD as well as additional programs as appropriate.
Responsibilities
Responsibilities will
include working with the medical team to oversee the conduct of clinical
trials of novel anti-tumor agents for the clinical programs within the Medical
Research department. This individual will participate in program planning,
selection and evaluation of CROs and other external vendors, site selection
and site monitoring visits to assure adherence to good clinical practices,
S.O.P.'s and protocols, and manage CRO activities both in the US and Europe.
In addition, responsibilities will include to: (1) collaborate with the
medical team to identify and manage clinical task milestones, (2) prepare and
oversee program timelines, (3) prepare and review of protocols, amendments,
consent forms, case report forms, (4) prepare clinical portions of regulatory
documents as required, (5) review site visit reports, case report form and
safety documents, (6) review clinical trial data, and (7) prepare and review
clinical study reports. Additional responsibility will be to review
newly-created S.O.P.'s, as well as update and/or identify, draft and review
new S.O.P's in conjunction with Quality Assurance as they relate to Medical
Research.
Technical Skills
Extensive knowledge
and understanding of the clinical trial process and GCP/ICH mandatory.
Requirements
This position
requires an individual with at least a BS, with an MS and/or RN preferred, and
preferably expertise in oncology/hematology. In addition, the individual must
have a minimum 7 years biotechnology/pharmaceutical work experience, with at
least 5 years in industry, including Clinical Research Associate experience,
or exceptional qualification for the position, such as relevant experience
during training. Effective oral and written communication skills are required,
as are excellent interpersonal skills with a demonstrated ability to work in a
team environment as well as independently, and thrive in a fast-paced setting.
In addition, the qualified candidate will have prior team leadership
experience in the clinical operations setting. Travel time is approximately
20% including visits to investigative sites and attendance at major clinical
meetings.
Senior Research Scientist: External Collaborations
Job Code: SRS/EC-VR
We are seeking a
highly motivated scientist to fill a new position in our Research group. In
this key role, the successful candidate will coordinate all levels of
interactions with external contract and academic labs that are performing
clinical and preclinical studies with AP23573, our mTOR inhibitor for cancer.
Responsibilities will include evaluating proposals, coordinating the
preparation of legal documents and transmission of reagents, monitoring and
interpreting results and liaising with our Clinical, Regulatory and
Development groups. Excellent teamwork, organizational and communication
skills are essential. The candidate must have an PhD in the life sciences with
a minimum of 3 years of additional experience in a research environment.
Though laboratory work will not be involved, a background in cancer or signal
transduction research is desirable.
Senior
Research Scientist: Preclinical Pharmacology/Oncology
Job Code: SRS/PPO-JI
We are seeking a
Senior Research Scientist experienced in designing, implementing and
interpreting in vivo tumor model studies for use in the discovery and
development of novel anti-cancer drugs.
Specific
Responsibilities:
-
Design, implement and interpret
in vivo studies in tumor models to determine the potential activity of novel
drugs when administered either alone or in combination with other anti-tumor
agents.
-
Design, implement and interpret
in vivo anti-tumor studies aimed at determining drug mechanism of action.
-
Interact with the Medical
Department and the Biology Department to assure appropriate preclinical
efficacy studies are designed to answer specific questions and to support
clinical therapeutic goals.
-
Prepare technical reports on
study observations.
-
Assist in the preparation of
Preclinical IND/NDA sections for regulatory submissions.
-
Oversee and prepare reports on
other activities in the pharmacology group including exploratory toxicology,
pharmacokinetics and other in vivo models of efficacy as necessary.
Requirements:
-
Ph.D. degree in pharmacology or
other related biological science.
-
A minimum of 2 years experience
in oncology research within the pharmaceutical/biopharmaceutical industry or
within a cancer research center.
-
Excellent communication,
organization and interpersonal skills along with excellent writing skills.
Scientist: NMR Spectroscopy
Job Code: NMR-DD
We are seeking a
self-motivated individual with a scientific background in small-molecule NMR
spectroscopy as a NMR system administrator/operator to support our
pre-clinical and clinical Drug Discovery programs.
The successful
candidate will be expected to support the on-going activities of our Medicinal
Chemistry Drug Discovery group, including administration, routine maintenance
and trouble-shooting of our open-access 300 and dedicated 600 MHz NMR
instruments. Specific responsibilities include the use of multinuclear 1D and
2D NMR spectroscopy to characterize the structure of novel chemical entities,
including those derived from natural products, as well as characterization of
chemical impurities and metabolites in both Drug Discovery and Development
settings, and subsequent data reduction and reporting to our project teams and
for inclusion in regulatory filings.
Candidates should be
able to work independently, demonstrate good organizational and strong
interpersonal skills. Excellent written and presentation skills are essential.
Candidates should have an M.S. or equivalent degree in Chemistry or equivalent
discipline, as well as 3+ years of relevant work experience in NMR
spectroscopy and NMR system administration, preferably in a multi-user open
access setting. Experience with Bruker NMR systems is an advantage.
Clinical SAS Programmer / Senior Clinical SAS Programmer
Job Code: SAS-RL
Job Description
As a key member of
the medical research team, you will participate in the gamut of activities
involved in preparation, analysis and presentation of clinical trial data. The
successful candidate will lead programming efforts on various projects, and
write programs to generate listings and summaries to be included in clinical
trial reports. In addition, the SAS programmer will serve as a primary liaison
with external vendors, and develop specifications, guidances and applicable
SOPs. This is a unique opportunity to apply your experience and vision in a
fast-paced, growing Medical Research Department.
Responsibilities
The SAS Programmer
will be responsible for the overall application of SAS based programs for the
extraction and presentation of data from clinical trial databases, including:
-
Participate in the development
and review of case report forms.
-
Develop report specifications
(tables and listings).
-
Participate in the review and
preparation of statistical analysis plans.
-
Hands-on preparation of SAS
codes for the generation of summary tables, data listings, and graphical
plots of clinical trial data, including validation procedures for programs
developed.
-
Oversee all aspects of
programming related activities by external vendors to ensure that
deliverables meet specifications and study timelines, and that appropriate
quality assurance procedures are followed.
-
Prepare datasets for submission
to regulatory agencies.
-
Import and review data from
external vendors (e.g., clinical laboratories).
-
Perform adhoc analyses of
clinical trial data under the guidance of the lead statistician, Medical
Director and/or study team.
-
Develop programming guidelines
and SOPs.
-
Participate in the evaluation
and selection of software and hardware systems.
Technical Skills
Proficient in SAS
programming, including SAS/SQL, SAS/GRAPH, etc., as well as MS office
products.
Requirements
Minimum of a
Bachelor's degree in an applicable field and at least 3 years of SAS
programming experience, including at least 3 years of pharmaceutical or
biotechnology industry experience. Strong organizational, analytical, and
communication skills are required. Position and responsibilities will be
commensurate with past experience. Knowledge of statistical analyses applied
in the clinical research setting, particularly in Oncology clinical trials, is
a plus.
Desktop Support Engineer
Job Code: DSE-RB
Responsibilities/Duties
Provide Level 1 and
Level 2 support to Macintosh and PC users including HW, OS and office
applications.
Desktop
infrastructure includes:
Power Macintosh with
Mac OS version 8.X and 9.X
Windows based systems
with NT, 2000 and XP.
Installation and
upgrade of Macintosh and PC HW and SW
Troubleshooting and
resolution of system and application problems.
Required
Qualifications
2+ years Windows XP
support; 2+ years Macintosh Support; 2+ years supporting Exchange/Outlook on
MAC and PC; experience with MAC X; advanced knowledge of MS Office Products;
MS Project Support experience; Active Directory administration; excellent
communications skills and excellent Interpersonal Skills.
Research Associate: Analytical/Bioanalytical Chemistry
Job Code: ARA-DD
We are seeking highly
motivated scientists to join the analytical/bioanalytical group to develop and
apply analytical methodologies for the quantitation of small-molecule-molecule
compounds. The group is involved in a variety of arias: characterization of
pure compounds and intermediates; quantitation of dosing solutions; in vitro
analysis of the plasma and metabolic stability of compounds and quantitation
of compounds from blood and plasma matrices for pharmacokinetic analysis. The
successful candidate will be proficient in HPLC method development and
application (principally reverse phase) with various detection schemes (UV,
florescence, and/or mass spectrometry), and sample preparation techniques from
biological matrices (liquid-liquid extraction and/or solid phase extraction).
Experience with in vitro metabolic studies and pharmacokinetic profiling and
the preparation of dosing formulations is an advantage. Applicants should have
a B.S. or M.S. degree in chemistry or related field and at least 1+ years of
full-time industrial experience. Prior pharmaceutical experience in drug
discovery chemistry is desirable.
Research Associate: Cell and Molecular Biology
Job Code: RA/CMB-VR
We are seeking a
highly motivated biologist to perform research to further our clinical and
preclinical signal inhibitor programs. The successful candidate will perform
in vitro and in vivo-based assays to assess the efficacy of our clinical
candidate drugs. The candidate must have a strong background in cellular and
molecular biology and outstanding technical skills. Experience with mammalian
cell culture, Western and ELISA assays is essential. The candidate must have a
BS/BA in the life sciences with a minimum 3 years of relevant experience.
Excellent teamwork and communication skills are required.
Research Associate: GLP Operations
Job Code: RA/GLP-VR
We are seeking a
highly motivated scientist to join our clinical assays group as a member of
the GLP laboratory. Responsibilities will include validating and carrying out
immunoassays on clinical specimens, performed in compliance with FDA GLP
regulations. The successful candidate will play an important role in
conducting a number of assays being conducted for multiple clinical trials.
Excellent teamwork, organizational and technical skills are essential. The
candidate must have a BS/BA in the life sciences with a minimum 2 years of
experience working in a GLP environment. Experience with immunoassays such as
ELISAs and Westerns is required
Research Associate: Molecular Biology
Job Code: RA/MB-RP
We are seeking an
individual to join our biology team to assist in research supporting our
clinical and preclinical oncogenic signaling inhibitor programs.
Responsibilities will include gene cloning, mammalian cell culture, including
transient and stable transfection, and analysis of kinase inhibitor action in
various tumor and engineered cell lines. Strong molecular biology skills are
essential, and experience with western blotting, ELISA and other molecular
assays, retroviral vectors and/or FACS analysis would be an advantage. A BS or
MS degree with 2 or more years of experience is required.
Research Associate: Preclinical Pharmacology
Job Code: RA/PP-JI
We are seeking a
Research Associate to perform in vivo pharmacology and pharmacokinetic studies
on a new generation of small molecule drugs. Studies will be performed in
appropriate in vivo models to support drug discovery and drug development
programs on novel anti-cancer agents.
Responsibilities:
Responsibilities
include preparation of model systems, administration of drugs by various
routes of administration, data collection and preparation of study reports.
Requirements:
Applicants should
have a B.S. or M.S. degree in a biological science and 1-3 years of academic
or industrial experience in a pharmacology laboratory or a related in vivo
scientific laboratory.
Research Associate: Protein Purification/Crystallography
Job Code: PP/C-DD-XZ
We are seeking a
self-motivated individual with a scientific background in protein expression,
protein purification and in the crystallization of protein-ligand complexes to
support our pre-clinical Drug Discovery programs.
Specific
responsibilities of the position include expression in E. coli and baculovirus,
protein purification and characterization, protein and protein-ligand
crystallization studies as well as X-ray diffraction data aquisition.
Experience in protein expression and purification is required for this
position and experience in protein crystallization and familiarity with X-ray
diffraction systems is desirable.
Candidates should be
able to work independently, demonstrate good organizational and strong
interpersonal skills. Excellent written and presentation skills are essential.
Candidates should have a B.S. or M.S. or equivalent degree in Chemistry,
Biochemistry, or equivalent discipline, as well as 3+ years of relevant work
experience in protein purification, preferably in a structural chemistry
environment.
