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| Below you will find a list of immediate job openings. Updated May 6, 2008. |
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Regards,
Steven J Pruner
CyberDivan Recruiting
919-598-0110
877-298-1190
919-957-3301 fax
| Job ID |
Job Title |
Location |
Salary |
| DS-03268-1 |
Sr. Clinical Project Manager |
Memphis, TN |
OPEN |
| PCR-12207-1 |
Associate Clinical Project Manager |
Evansville, IN |
70-90k |
| DS-01108-3 |
Associate Director, Clinical Affairs |
Branchburg, NJ |
to 130k |
| TRS-02158-7 |
Associate Director, Postmarketing Regulatory Affairs |
Woodcliff Lake, NJ |
Open |
| TRS-02158-9 |
Associate Director, Regulatory Affairs - Sepsis/GI |
Ridgefield Park, NJ |
Open |
| TRS-02158-8 |
Associate Director, Regulatory Affairs, CNS |
Ridgefield Park, NJ |
Open |
| TRS-02158-6 |
Associate Director, Regulatory Affairs, Nonclinical |
Ridgefield Park, NJ |
Open |
| TB-07277-2 |
Associate Director/ Director Clinical Affairs |
Rye Brook, NY |
120-145K |
| CLM-01078-1 |
Associate Director/Director Biostatistics |
Atlanta. GA |
OPEN |
| CLM-02018-2 |
Associate Director/Director Biostatistics |
San Jose, CA |
OPEN |
| PCR-10027-1 |
Associate Director/Director of Clinical Research |
Upper Gwynedd, PA |
OPEN |
| CLM-09277-5 |
Associate Director/Director, Project Management |
Atlanta, GA |
90110k |
| TRS-02158-15 |
Associate Director/Director, Sepsis and Anti-Infectives |
Ridgefield Park, NJ |
Open |
| TRS-02158-4 |
Associate Director/Senior Manager, Drug Regulatory Affairs C |
Ridgefield Park, NJ or RTP, NC |
Open |
| RC-03058-1 |
Associate Medical Director |
Redwood City, CA |
to 175K + Bonus |
| DS-09247-2 |
Associate Research Scientist |
Tarrytown, NY |
52-65K |
| TRS-02158-16 |
Associate Vice President - Global Therapeutic Area Head, On |
Ridgefield Park, NJ |
Open |
COR-04298-1 |
Business Development Director |
Cincinnati, OH |
OPEN |
| CLM-01248-1 |
Clinical Data Associates |
San Diego, CA & Mississauga, ON |
OPEN |
RG-11267-7 |
Clinical Logistics Manager |
Tarrytown, NY |
to 110k |
| CLM-01038-1 |
Clinical Project and Program Managers |
East Coast |
Open |
| CLM-01038-2 |
Clinical Project and Program Managers |
Atlanta, GA |
Open |
| CLM-09287-3 |
Clinical Project Manager |
Atlanta. GA |
to 98k + Bonus |
| CM-02278-1 |
Clinical Project Manager |
Norristown, PA |
to 110k |
[FEATURED JOB]
LP-05028-2 |
Clinical Project Manager |
Philadelphia Area |
100-110k |
| TB-01158-6 |
Clinical Project Manager |
Southborough, MA |
90-95K |
| CLM-09187-1 |
Clinical Project Manager - Oncology |
All US Locations |
to 98k + Bonus |
| DS-01318-2 |
Clinical Project Manager-Cardiovascular |
Mid West & East Coast |
70-90k |
| PC-05167-1 |
Clinical Protocol Manager |
Wallingford, CT |
Open |
| PC-05167-2 |
Clinical Protocol Manager |
Lawrenceville, NJ |
Open |
| TI-07117-1 |
Clinical Scientist |
Chadds Ford, PA |
100-120K |
PCR-05068-8 |
Clinical Study Manager |
Stamford, CT |
90-105K |
[FEATURED JOB]
GT-03318-2 |
Clinical Trial Manager III |
San Francisco, CA |
OPEN |
| TI-07117-4 |
CNS Clinician (Associate Director/Director level) |
Groton, CT |
OPEN |
[FEATURED JOB]
LP-05028-1 |
CRA |
Philadelphia Area |
OPEN |
| PC-07186-1 |
CRA I/II |
Princeton, NJ, Blue Bell,RTP,San Diego, Boston |
40-65K |
[FEATURED JOB]
PN-11307-1 |
CRA I/II |
Westcoast |
Open |
| TB-01158-4 |
CRA II/Lead CRA |
Southborough, MA |
70-80k |
| OS-08307-1 |
CRA III -Device |
Sf Bay Area |
80-90k |
| RG-11267-2 |
CRA in-house Low Travel |
Tarrytown, NY |
65-95K |
| TB-01158-10 |
Dir. of Clinical Research and Development |
San Francisco, CA |
|
RC-04288-1 |
Director Clinical Research, Infectious Diseases |
San Francisco, CA |
to 230K |
| TB-03208-1 |
Director of Clinical Operations |
Chicago, IL |
OPEN |
[FEATURED JOB]
HDS-11207-1 |
Director of Research and Development (DRD) |
Miramar, FL |
OPEN |
| PS-07076-7 |
Director, Biostatistics (CNS) (EGC) |
Ridgefield Park, NJ |
Open |
| DS-01108-6 |
Director, Clinical Data Management |
Branchberg, NJ |
140-160k |
| PC-05026-2 |
Director, Clinical Research |
Princeton, NJ |
110-130k |
| TRS-02158-13 |
Director, CNS |
Ridgefield Park, NJ |
Open |
| TB-03038-1 |
Director, Project Management |
San Diego, CA |
130K + 15% |
| RC-03058-2 |
DIRECTOR/SENIOR DIRECTOR, MEDICAL AFFAIRS HIV |
San Francisco, CA |
200-250k |
| TRS-02158-17 |
Director/Senior Director, Gastroenterology |
Ridgefield Park, NJ |
Open |
| TRS-02158-5 |
Director/Senior Director, Imaging |
Ridgefield Park, NJ |
Open |
| TRS-02158-14 |
Director/Senior Director, Oncology |
Ridgefield Park, NJ |
Open |
| RC-03058-3 |
DIRECTOR/SR DIRECTOR, MEDICAL AFFAIRS HEPATITIS PROGRAM |
San Francisco, CA |
200-250k |
PCR-05068-9 |
Drug Safety Analyst |
Stamford, CT |
75-95K |
| TB-01158-9 |
Drug Safety Physician |
Waltham, MA or Durham, NC |
160-200k |
PCR-05068-10 |
Drug
Safety Specialist II |
Paramus, NJ |
to
80K |
| [FEATURED JOB]
TB-08287-1 |
Global Head Pharmacovigilance Operations
|
Boston, MA |
225K |
| CLM-01078-2 |
Manager Biostatistics |
Atlanta. GA |
OPEN |
| CLM-01248-2 |
Manager, Clinical Data Associates |
Atlanta, GA |
OPEN |
| CLM-09287-1 |
Manager, Clinical Data Management Operations
|
Atlanta, San Jose, San Diego, Mississauga,
On. |
OPEN |
| DS-01108-2 |
Manager, Clinical Projects |
Branchburg, NJ |
100k |
| DS-01108-4 |
Manager, Clinical Projects |
Branchburg, NJ |
100k |
| PC-07186-3 |
Manager, Clinical Research |
Princeton, NJ; Blue Bell PA |
80-100k |
| TRS-02158-10 |
Manager, Regulatory Affairs -
Oncology |
Ridgefield Park, NJ |
Open |
| PS-07076-1 |
Manager/ Sr Manager, Clinical Operations,
CNS |
Ridgefield Park, NJ |
$95k-$125K |
| TB-07117-6 |
Medical Director |
Boston, NY, NJ, San Francisco, San
Diego |
200-250K |
| CLM-01248-3 |
Medical Writer |
Atlanta, GA & Missassauga, ON |
OPEN |
[FEATURED JOB]
IN-09127-1 |
Medical Writer |
Clinton, NJ |
60-65k |
RG-11267-4 |
Medical Writer |
Tarrytown, NY |
to
85k |
| PS-07076-4 |
Medical/Sr Medical Writer |
Ridgefield Park, NJ |
$80s |
| PC-11157-5 |
Principal Biostatistician |
Hopewell, NJ or Wallingford, MA |
110-110K |
| PS-07076-8 |
Process Validation Scientist |
Davie, Fl |
$60K-$70k |
| PC-07186-15 |
Project Associate I/II |
Princeton, NJ, Blue Bell,RTP,San Diego,
Boston |
Open |
| CLM-09187-2 |
Project Associate Supervisor |
San
Jose, San Diego |
to 98k +
Bonus |
| PS-07076-3 |
Quality Manager, Medical Writing |
Ridgefield Park, NJ |
$95k-$110k |
[FEATURED JOB]
HR-09217-1 |
RA/QA Advanced Engineer |
RTP,
NC |
Open |
| TB-01158-5 |
Regional CRA I |
Westcoast or CA |
80-90k |
| CLM-02068-1 |
Regional Clinical Project Manager -
Oncology |
East
of The Rockies |
Open |
[FEATURED JOB]
CIR-01168-1 |
Regional CRA |
Most
USA locations |
OPEN |
| CLM-09277-1 |
Regional CRA |
Canada |
OPEN |
| CLM-09277-3 |
Regional CRA |
All
US Locations |
OPEN |
| DS-01318-1 |
Regional CRA |
Mid
West & East Coast |
70-90k |
PCR-05068-1 |
Regional CRA |
Texas |
to
85K |
PCR-05068-11 |
Regional CRA |
NYC |
95-100K |
PCR-05068-12 |
Regional CRA |
Boston Near Logan Airport |
95-100K |
PCR-05068-2 |
Regional CRA |
California |
to
85K |
PCR-05068-3 |
Regional CRA |
Flordia |
to
85K |
PCR-05068-4 |
Regional CRA |
Northeast - NY/NJ/PA |
to
85K |
| TB-07277-1 |
REGIONAL CRA I |
Northeast & West Coast |
60-90K |
| CLM-03078-1 |
Regional CRA Midwest |
Midwest |
OPEN |
| PC-07186-7 |
Regional CRA/Regional CRA II |
USA
Wide |
Open |
[FEATURED JOB]
RG-11267-1 |
Regulatory Associate IV |
Tarrytown, NY |
to
95k |
| DS-01108-1 |
Regulatory Manager |
Branchburg, NJ |
Open |
| PC-11157-3 |
SAS
Principal Analyst II |
Hopewell, NJ |
90-95k |
| PC-11157-4 |
SAS
Principal Analyst II |
Wallingford, CT |
90-95k |
| CLM-02018-1 |
SAS
Senior Statistical Programmer/Analyst |
San
Diego & Mississuaga, ON |
Open |
| PC-11157-1 |
SAS
Technical Manager |
Wallingford, CT |
100-110k |
| PC-11157-2 |
SAS
Technical Manager |
Hopewell, NJ |
100-110k |
| CLM-09228-1 |
Senior Business Development Manager |
Mississuaga, ON |
Open |
| CLM-09277-6 |
Senior Business Development Manager |
Boston, MA & San Jose, CA |
Open |
| TRS-02158-12 |
Senior Clinical Research Scientist,
CNS |
Ridgefield Park, NJ |
Open |
| TRS-02158-11 |
Senior Clinical Research Scientist,
Oncology |
Ridgefield Park, NJ |
Open |
PCR-05068-7 |
Senior Clinical Study Manager |
Stamford, CT |
100-115k |
| DS-01118-1 |
Senior CRA |
Mountian View, CA |
95-105K |
| IN-07177-1 |
Senior CRA |
Clinton, NJ |
OPEN |
| TRS-02158-3 |
Senior Director/Director, Clinical
Pharmacology |
Ridgefield Park, NJ |
Open |
| PS-07076-2 |
Senior Manager, Clinical Operations,
Sepsis |
Ridgefield Park, NJ |
$110k-$125K |
| TRS-02158-1 |
Senior Manager, Clinical Pharmacology
|
Ridgefield Park, NJ |
Open |
| TRS-02158-2 |
Senior Manager, Clinical Pharmacology |
Ridgefield Park, NJ |
Open |
RG-11267-5 |
Senior Medical Safety Associate |
Tarrytown, NY |
to
110k |
| PS-07076-10 |
Senior Quality Engineer |
Davie, FL |
$65 -
$80K |
| PS-07076-9 |
Senior Scientist |
Davie, Fl |
60-80k |
[FEATURED JOB]
PN-11307-2 |
Sr
CRA West Coast Regional |
Westcoast |
Open |
PCR-05068-5 |
Sr.
Clinical Project Manager |
Bedminster, NJ |
to
120K |
PCR-05068-6 |
Sr.
Clinical Project Manager |
Tustin, CA |
to
120K |
| PCR-09207-4 |
SR.
CLINICAL RESEARCH SCIENTIST |
Summit, NJ |
130-145K
+ Bonus |
| PC-07186-2 |
Sr.
CRA |
Blue
Bell, PA, Princeton, NJ, Chicago, IL,San Diego, CA |
Open |
| PCR-10276-1 |
Sr.
CRA |
Piscataway, NJ and Bridgewater, NJ |
70-80K +
10% bonus |
[FEATURED JOB]
RG-11267-3 |
Sr.
CRA/Clinical Trial Manager |
Tarrytown, NY |
to
100k |
| CM-02157-1 |
Sr.
Director Clinical and Regulatory Affairs |
Princeton, NJ |
to 160k
+ 20% |
PCR-04148-1 |
Sr.
In-House CRA |
Stamford, CT |
$60-65
per hour |
| DS-08307-1 |
Sr.
QC Specialist |
Tarrytown, NY |
50-60k |
| DS-09247-1 |
Sr.
Scientist, QC/Analytical Development |
Tarrytown, NY |
80-100k |
RG-11267-6 |
Tactical Project Leader - Oncology |
Tarrytown, NY |
to
150K |
| TB-07117-4 |
Vice
President of Clinical Research |
Boulder, CO |
280-300K+ |
| TB-01158-1 |
VP
of Clinical Development |
Emeryville, CA |
250-300K+ |
| TRS-02158-18 |
VP/Assoc VP/Sr. Director Global Therapeutic
Area Head - CNS |
Ridgefield Park, NJ |
Open |
Scroll down or click
on the Job ID for further details.
Please feel free to contact me if you need more
information.
|
| Job List |
| Job ID: |
DS-03268-1 - Sr. Clinical Project Manager |
| Description: |
This Company develops and markets advanced
medical devices that help healthcare professionals treat patients
more effectively. For the last 150 years, this Company has developed
advanced medical devices for healthcare professionals around the
world.
This
company is currently looking for a Sr. Clinical Project Manager
Job Description
You will be
responsible for the management of regulated and scientific clinical
trials and will be expected to:
(a) Develop
clear measurable project timelines with milestones,
(b) Manage contract negotiations with sites and
other study business partners, (c) Develop and manage study budgets
(d) Review/prepare FDA trial submissions,
(e) Develop protocols,
(f) Interact with site Investigators and staff,
and
(g) Implement and oversee all aspects
of study management.
You must have the ability to form and motivate
cross functional groups in order to accomplish project related
objectives. You will work with management and staff in all areas.
Medical device experience a plus.
Travel both domestic and international required
30% of the time.
Candidate Must Have :
-
Bachelors degree with a major in life sciences, nursing, medical
technology or related area. (Masters preferred)
- Minimum of five (5) years clinical affairs or
related experience plus two (2) years of prior healthcare. Four (4)
years of experience required with a Masters degree
- Extensive knowledge of FDA and IDE
Relocation is allowed
and will be discussed during the interview process
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Memphis, TN |
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| Job ID: |
PCR-12207-1 - Associate Clinical Project Manager |
| Description: |
Position Description and Responsibilities:
The Clinical Project Manager is responsible for
independently managing and overseeing all operational aspects of
nutritional clinical trials. The incumbent will ensure that clinical
trial data in support of regulatory submission and product messaging
are of high quality and valid. Responsibilities will include, but
will not be limited to:
Participating in
the design and development of clinical study protocols and Case
Report Forms (CRFs).
Conducting
investigator identification, selection, evaluation, initiation, and
training.
Managing protocol approval
process, including IRB/Ethics Board submission and approvals.
Managing contract clinical monitors to ensure
monitoring efforts meet established timelines and deliverables.
Developing and negotiating site budgets.
Serving as the lead Sponsor contact for
resolving site related issues.
Managing
projects by coordinating activities and organizational entities to
keep projects on established timelines.
Generating project documentation (including but not limited to)
project specifications, project reports, communication records
(logs), meeting agendas and minutes, and status reports.
Position Requirements
and Necessary Skills:
Thorough knowledge
of ICH and GCP guidelines for clinical research.
Ability to identify deviations from project
plan and to work with project team and management to develop
corrective action plans.
Ability to work
in a team environment.
Ability to
understand and review detailed clinical reports.
Knowledge of project management tools and
practices.
Ability to manage multiple
projects at varying stages of completion.
Effective in setting and meeting personal short- and long-term goals
to complete assignments.
Ability to
anticipate problems relating to projects and to develop and
implement solutions.
Excellent
communication and organizational skills.
Solid leadership skills.
Strong MS Office
skills.
Qualifications and Experience:
BA/BS, preferably in a scientific field, or
equivalent knowledge gained through experience working in a
scientific area.
At least 4 years of
clinical research experience including field monitoring of clinical
trials.
Thorough understanding of
traditional CRA skills (site identification, monitoring, tracking,
data collection and cleaning)
Practical
experience of clinical trial methodology (study design).
|
| |
Salary: 70-90k, Job Type: Permanent, Total Exp: 3 Yrs ,
Start Date: ASAP,
Location: Evansville, IN |
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|
| Job ID: |
DS-01108-3 - Associate Director, Clinical
Affairs |
| Description: |
This is a biopharmaceutical company dedicated
to developing breakthrough biologic medicines in the area of
oncology. The Company has utilized the many advances made in the
fields of molecular biology, oncology, genomics, and antibody
engineering to build a novel pipeline of product candidates designed
to address specific genetic mechanisms involved in cancer growth and
development.
Their goal is to become a
fully-integrated biopharmaceutical company that has the capability
and resources to take its novel pipeline compounds and develop them
from the research and development stage through to commercial
manufacture, marketing and sales. With their first innovative cancer
drug on the market and late stage clinical candidates soon to be,
they have cooperative agreements with several big pharmaceutical
companies to help market their drugs. A solid, fast growing midsized
company which incorporates the best of both worlds, security with
room to grow.
Currently looking for an:
Associate Director, Clinical Affairs
GENERAL SUMMARY
Directs the conduct of assigned clinical
investigations and activities associated with it. Performs assigned
responsibilities to ensure timely completion of departmental goals
and objectives. Prepares and distributes ad hoc reports, summaries,
analyses. Participates in the periodic review and revision of
departmental policies and SOPs to ensure compliance with corporate
policies, GCPs, or regulations involving governmental agencies. Has
direct involvement with the selection of new hires. Trains, develops
and supervises clinical staff.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Directs the conduct
of assigned clinical investigations and activities associated with
it.
Supervises training programs to assure
consistency and compliance in monitoring of clinical
investigations.
Prepares and distributes
ad hoc reports, summaries, or analyses as required. Prepares status
reports for assigned clinical investigations.
Prepares drug usage projections and tracking
for assigned clinical investigations as requested.
Participates in the periodic review and
revision of departmental policies and SOPs to ensure compliance
with corporate policies, good clinical practice procedures (GCPs),
or regulations of governmental agencies.
Has direct involvement in the selection process of new hires,
including reviewing candidates credentials, interviewing candidates,
and making hiring recommendations.
May
assist with preparation and execution of Investigator meetings.
Prepares department budgets, timelines, and
project plans.
Maintains professional
skills by keeping abreast of literature, attending conferences,
courses and meetings.
Maintains knowledge
of U.S. and foreign regulations, guidelines, policies and practices
for conducting clinical investigations.
Follows departmental policies, procedures and SOPs .
Trains, develops and supervises clinical
staff.
Negotiates contracts and budgets
for assigned clinical investigations..
Develops and reviews study protocols and CRFs.
Participates in internal/external audits.
Responsible for producing final study
reports.
Participates in dissemination of
clinical information to the clinical team members, as
appropriate.
Provides leadership and
assists as appropriate in managing the clinical research department
in an effective manner.
Serves on cross
teams for evaluation of new clinical research strategies.
May act as a company spokesperson regarding
publication and presentations of clinical research findings.
Coordinates cross functional efforts to
improve clinical development. Identifies issues that may impact the
overall project plans and initiates contingency plans as
appropriate.
Directs departmental resource
planning, budgeting, and timeline setting to meet the companies
needs.
Provides clinical support in
working with the FDA, including the 510(k), and pre-market approval
submissions and responses to FDA questions.
ESSENTIAL KNOWLEDGE,
SKILLS AND EXPERIENCE
7-10 years experience of progressively
increasing clinical research experience within the pharmaceutical
industry.
Experience in drug development,
especially Food and Drug Administrations regulations and Good
Clinical Practices or Associates of Clinical Pharmacology CRA
certification.
Experience in IND/NDA/BLA
submissions.
An advanced degree (M.S. or
PharmD) is preferred. A minimum academic degree in Nursing (R.N. or
B.S.N.), Life Sciences (B.A. or B.S.), Pharmacy or Medicine.
Experience requirements may be less with advanced degrees.
Excellent problem solving and team building
skills.
Ability to resolve and make
judgements regarding administrative, scientific and/or clinical
problems with minimal supervision.
Ability
to deliver oral presentations and write in a clear, focused, and
concise manner.
|
| |
Salary: to 130k, Job Type: Permanent, Total Exp: 7-10 Yrs,
Start Date: ASAP,
Location: Branchburg, NJ |
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| Job ID: |
TRS-02158-7 - Associate Director, Postmarketing Regulatory
Affairs |
| Description: |
Description:
The
incumbent will be responsible for, but not limited to the following:
Providing regulatory input into strategic
marketing initiatives and ESI policies regarding advertising and
promotional activities
Reviewing and
approval of all advertising and promotional materials for assigned
products to insure that they comply with FDA regulations
Developmenting, implementating and the
maintaining of regulatory procedures regarding review of advertising
and promotional materials for marketed products
Acting as regulatory liaison with co-promote
partners regarding promotional review
Acting as DDMAC liaison for assigned marketed products to facilitate
FDA review
Overseeing overall regulatory
labeling function for marketed products
o
Supervising of Regulatory Coordinator for Labeling
o Coordinating with package engineering group
for labeling review and approval
o Creating
and maintaining all labeling files, including labeling history,
current labeling, and change control.
o
Assuring utilization of most current labeling in marketing materials
Qualifications:
Minimum BS degree or higher in life
science
Five years pharmaceutical
regulatory experience
At least 2 years
experience reviewing advertising and promotional materials for
prescription drugs or biologics
2 to 5
years of US prescription drug labeling experience, including FDA
labeling negotiations and Core Data Sheets (as they translate to
local labeling)
Knowledge of FDA
regulations and guidance documents regarding advertising/ promotion
and labeling requirements
Good knowledge
of MS Office applications (MS Word, Excel, PowerPoint)
Must be very detail oriented
Must be able to work in a team environment
Must be able to function under tight
timelines |
| |
Salary: Open, Job Type: Permanent, Total Exp: 2-5 Yrs,
Start Date: ASAP,
Location: Woodcliff Lake, NJ |
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| Job ID: |
TRS-02158-9 - Associate Director, Regulatory Affairs -
Sepsis/GI |
| Description: |
Description:
Develop, implement & execute regulatory strategic plans &
best practice departmental procedures for the GI and Sepsis group
Provide regulatory guidance for top-level
project development/core teams
Responsible for managing complex regulatory submissions &
communicating regulatory issues to functional areas &
transmitting regulatory concerns from functional areas to Sr.
Management
Actively liaise with FDA &
regulatory authorities to provide/solicit guidance & support for
complex submissions
Research &
develop regulatory intelligence concerning competitor products
Staff training/management &
self-development: supervise Regulatory Managers & Associates
providing guidance, training & development to staff
members/teams
Qualifications:
BS
in scientific discipline required (Life Sciences, Chemistry,
Toxicology or Pharmacology) required, Advanced degree preferred
5-8 years pharmaceutical experience, at least
4 of which in the regulatory environment
Experience managing mulitple complex submissions & leading FDA
or regulatory agency meetings preferred
Comprehensive knowledge of FDA rules, regulations & guidelines
& their application in clinical research & development is
essential
Experience in managing
relationships and interfacing with regulatory bodies as an
articulate communicator with strong negotiation skills a plus
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 5-8 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-8 - Associate Director, Regulatory Affairs,
CNS |
| Description: |
Description:
The
incumbent is responsible for but not limited to the following:
Develop, implement and execute regulatory
strategic plans and best practice departmental procedures for the
therapeutic area group.
Provide
regulatory guidance for top-level project development/core teams.
Actively liaise with FDA and regulatory
authorities to provide/solicit guidance and support for complex
submissions.
Research and develop
regulatory intelligence concerning competitor products and
disseminate competitive intelligence to project and core teams.
Staff training/management and
self-development.
Qualifications:
Bachelors degree in scientific discipline
required (Life Sciences, Chemistry, Toxicology or Pharmacology).
Doctorate degree highly desired (e.g., MD, JD, Pharm D, or PhD in
life sciences).
3-8 years FDA experience
as Project Manager or Clinical Reviewer.
Expert understanding of pharmaceutical operations and regulatory
compliance requirements together with broad understanding and
experience of the clinical development process a plus.
Expertise in managing relationships and
interfacing with regulatory bodies as an articulate communicator
with strong negotiation skills a plus. |
| |
Salary: Open, Job Type: Permanent, Total Exp: 3-8 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-6 - Associate Director, Regulatory Affairs,
Nonclinical |
| Description: |
Description:
The
incumbent is responsible for but not limited to the following:
- Regulatory expertise within at least 1
related area including clinical trial management, manufacturing,
non-clinical testing and marketed products together with broad
understanding & experience in the clinical development process
- 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.
- Contribute
to development results by providing regulatory leadership &
assume a supervisory and/or "subject matter expert" role with regard
to regulatory issues.
Qualifications:
Associate Director: MD, JD, PharmD or Ph.D. in the life sciences
highly desired. BS degree required in associated functional
discipline (Life Sciences, Chemistry, Toxicology or Pharmacology)
Associate Director: Minimum 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
Most posess
in-depth knowledge of appropriate Code of Federal Regulations &
Regulatory Guidance Documents
History of
working in complex team environments with numerous/diverse
stakeholders
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 10-12 Yrs, Start Date: ASAP,
Location: Ridgefield
Park, NJ |
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| Job ID: |
TB-07277-2 - Associate Director/ Director Clinical Affairs
|
| Description: |
Summary
Provide
leadership and supervision to the Clinical Affairs group in NY
office. Responsibilities include client interaction; defining
project requirements, deliverables, schedules and budgets; managing
project schedules and budgets; promoting SOP and policy compliance;
monitor resource needs; staff management, promoting the use of tools
and metrics.
Essential Duties and Responsibilities include
the following. Other duties may be assigned.
Develop and manage the project management
department including, but not limited to the following
areas.
Manage:
-Consistency
of project management and clinical monitoring regarding project
requirements, deliverables, schedules and budgets.
-Communication with clients and Client Project
Managers to promote project schedule adherence, ensure that projects
are adequately staffed with personnel and resources, and meet high
quality standards.
-Development and
maintenance of operations and procedure manuals, work guidelines,
department metrics and project tools.
Coordinate training and education programs to
ensure staff is trained as needed, including but not limited to
relevant therapeutic areas, ICH guidelines, and regulatory
requirements
Assist
with managing and monitoring the departmental budget. Monitor
department billable percentages.
Work closely with clinical project managers to
promote operational efficiency, teamwork, and high morale.
Interact with clients
in a customer service role and to ensure solid team relations.
Collaborate with staff
inter and intra-departmentally on the proposal development
process.
Assist in
Operations meetings and directives to improve department and
corporate policies and procedures.
Supervise projects involving monitoring,
database management, data management/entry, programming, statistics,
report writing, and agency presentations.
Make presentations and
represent company at professional meetings and to prospective and
existing clients.
Manage personnel activities, and provide
guidance for professional development of staff (coordinate resource
distribution across projects, interviews, makes hiring
recommendations, leads disciplinary actions, delivers performance
reviews.)
Additional Duties and Responsibilities:
Act as back-up for project managers.
Qualification
Requirements: To perform this job successfully, an individual must
be able to perform each essential duty satisfactorily. The
requirements listed below are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be
made to individuals with disabilities to perform the essential
functions.
Education and/or Experience:
BS/BA. 5 years industry experience including
and at least 5 years clinical trial experience; minimum 5 years
project and /or team management experience.
Other Skills and
Abilities:
Must have strong leadership and
management skills. Must have the ability to handle multiple projects
simultaneously and manage multi-functional teams; must have creative
problem solving skills; excellent verbal / written communication
skills. Must have strong computer skills. Must have strong time
management and organizational skills. Must have excellent knowledge
of at least two departmental processes and functions within the
Pharmaceutical Industry and drug development process.
Preferred
Qualifications
Advanced degree; 5+ years
project management experience within a CRO; 5+-years management
experience.
Physical Demands: The physical demands
described here are representative of those that must be met by an
employee to successfully perform the essential functions of this
job. Reasonable accommodations may be made to enable individuals
with disabilities to perform the essential functions.
Some stress may occur.
Some travel may be required. No special physical demands required.
Work Environment:
The work environment characteristics described here are
representative of those an employee encounters while performing the
essential functions of this job. Reasonable accommodations may be
made to enable individuals with disabilities to perform the
essential functions. This is an in-house position.
|
| |
Salary: 120-145K, Job Type: Permanent, Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: Rye Brook, NY |
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| Job ID: |
CLM-01078-1 - Associate Director/Director
Biostatistics |
| Description: |
JOB STATEMENT: The primary focus of this
position is to analyze, interpret and summarize safety and efficacy
data associated with Phase 1, 2, 3 and 4 clinical trials for
multiple new drug and biological products, as well as medical
devices.
ESSENTIAL JOB FUNCTIONS:
Consult with Sponsor clientele on clinical
study design, statistical analysis plans and interpretation of
results
Co-develop protocols, especially
statistical considerations section, e.g., sample size calculation
Mentor junior statisticians in the writing of
analysis plans, statistical reports and program specifications
Stay current in the field by networking and
making presentations
Allocate departmental
resources to maximize utilization and increase profitability
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Ph.D. in Biostatistics, preferably with one
or more publications related to clinical research
5 to 10 years related experience in clinical
trials in biopharmaceutical industry preferred
Excellent interpersonal, verbal and written
communication skills a pre-requisite for advancement
Proficient with SAS and other statistical
programming languages, e.g., S-PLUS
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 5-10 Yrs,
Start Date: ASAP,
Location: Atlanta. GA |
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| Job ID: |
CLM-02018-2 - Associate Director/Director
Biostatistics |
| Description: |
JOB STATEMENT: The primary focus of this
position is to analyze, interpret and summarize safety and efficacy
data associated with Phase 1, 2, 3 and 4 clinical trials for
multiple new drug and biological products, as well as medical
devices.
ESSENTIAL JOB FUNCTIONS:
Consult with Sponsor clientele on clinical
study design, statistical analysis plans and interpretation of
results
Co-develop protocols, especially
statistical considerations section, e.g., sample size calculation
Mentor junior statisticians in the writing of
analysis plans, statistical reports and program specifications
Stay current in the field by networking and
making presentations
Allocate departmental
resources to maximize utilization and increase profitability
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Ph.D. in Biostatistics, preferably with one
or more publications related to clinical research
5 to 10 years related experience in clinical
trials in biopharmaceutical industry preferred
Excellent interpersonal, verbal and written
communication skills a pre-requisite for advancement
Proficient with SAS and other statistical
programming languages, e.g., S-PLUS
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 5-10 Yrs,
Start Date: ASAP,
Location: San Jose, CA |
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| Job ID: |
PCR-10027-1 - Associate Director/Director of Clinical
Research |
| Description: |
The successful candidate will join an exciting
fast-paced department with active clinical development programs
within the Oncology area.
This includes all phases of clinical
development, including study design, study placement, study
monitoring and concern for the protection of human subjects
participating in clinical trials. Additionally, this person will be
responsible for the analysis and summary of clinical findings from
studies for the purpose of decisions regarding safety and efficacy
to support new drug submissions, new drug applications or clinical
experience reports, as well as serving as a member of appropriate
research project teams.
The company's Oncology effort has a particular
focus on the use of molecular profiling to identify specific
populations of patients most likely to benefit from our novel
therapies. Translational research molecular profiling projects are
performed in close collaborations with scientists.
The qualified
candidate will possess an M.D. or M.D./PhD, plus Board Certification
or eligibility. Those with a PhD and substantial post-doctoral
experience will also be considered. Experience in industry or
academia, a demonstrated record of scientific scholarship and
achievement, a proven track record in clinical medicine and a
background in biomedical research are essential.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 6 Yrs,
Start Date: ASAP,
Location: Upper Gwynedd, PA |
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| Job ID: |
CLM-09277-5 - Associate Director/Director, Project
Management |
| Description: |
ESSENTIAL JOB FUNCTIONS: Manage Program
Managers and Regional Project Managers
Management and prioritization of client resourcing in conjunction
with Directors of US, Canadian, and European Operations
Collaboration with Business Development staff
to ensure client proposals are consistent with Clinimetrics
capabilities
Participation on corporate
Project Management Team to standardize global, full-service project
management procedures and systems
JOB
REQUIREMENTS / EDUCATION / EXPERIENCE:
Masters level degree (e.g. MBA, MHA, MSN) preferred
Minimum 10 years clinical research experience
or equivalent, including three years prior project management
experience
Demonstrated management
skills
Excellent communications skills
Solid collaboration and negotiation skills
Ability to multi-task and problem solve
Excellent interpersonal skills
Strong leadership skills
Thorough knowledge of medical and
pharmaceutical industry, terminology, and practices
|
| |
Salary: 90110k, Job Type: Permanent, Total Exp: 10+ Yrs,
Start Date: ASAP,
Location: Atlanta, GA |
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| Job ID: |
TRS-02158-15 - Associate Director/Director, Sepsis
and Anti-Infectives |
| Description: |
Description:
The
incumbent is responsible for, but not limited to the following:
Primarily focusing on Infectious disease
Supporting the Sepsis/AI area function and
strategy
Leading problem solving across the
Sepsis/AI area with an enterprise-wide perspective: facilitating
team(s) to identify issues and propose solutions
Contributing to development results by
providing Sepsis/AI area leadership to assume a supervisory and/or
"subject matter expert" role with regard to therapeutic area issues.
Bringing external market perspectives,
sharing insight, and knowledge regarding therapeutic areas with
groups within own department and across Eisai, as appropriate
Providing technical insight to ensure progress
towards goals
Lead IPT or Study Teams, as
appropriate
Qualifications:
MD,
PhD or equivalent degree required
At least
3-5 years additional related experience for an MD or 7-10 years for
a PhD (including academic research)
Experience in a field relating to Sepsis/AI
Medical expertise and development experience
within an area relevant to Sepsis/AI especially as related to
infectious diseases
Significant experience
leading clinical trials
Working knowledge
of other functional areas (e.g., Clinical Operations, Regulatory
Affairs, Pre-clinical and Marketing)
Experience in translational research, working
with pre-clinical scientists, leading study/project teams
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 3-5,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-4 - Associate Director/Senior Manager, Drug
Regulatory Affairs C |
| Description: |
Description:
The
incumbent os responsible for, but not limited to the following:
Support commercial and corporate marketed
products initiatives
Development of CMC
dossiers and registration strategies in support of commercial
objectives
Assessment of change proposals
for marketed products and serve as the US Regulatory Representative
on Commercial Change Control Committee
Liaise and negotiate with FDA Review and Compliance divisions as
necessary
Provide Regulatory support
during FDA pre-approval inspections
Qualifications:
B.S.
degree in pharmacy, chemistry or a related discipline required,
advanced degree (MS, PhD) strongly preferred
5 or more years of Regulatory CMC experience
specifically supporting commercial operations
Experience interacting directly with the FDA
Experience in biologics is highly
derirable. |
| |
Salary: Open, Job Type: Permanent, Total Exp: 5-7 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ or RTP, NC |
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| Job ID: |
RC-03058-1 - Associate Medical Director |
| Description: |
Company:
The company is
a privately-held company that specializes in the development of
topical drug/dermatology products for biotechnology and
pharmaceutical clients. It provides a full range of product
development services including formulation, clinical development,
regulatory consulting, analytical support, cGMP clinical
manufacturing and clinical labeling. Located in Northern
California
Description:
The
Associate Medical Director is responsible for medical affairs
activities to support commercial brand strategies, and for providing
medical support to clinical affairs for dermatology clinical
programs in development
Specific responsibilities include:
Provide clinical expertise and approval of
clinical protocols, clinical study-related documents, clinical study
reports
Provide medical leadership of
brand-related medical information and detail aids, clinical
communications, publications, medical information
Lead the development and execution of the
post-approval clinical program in response to regulatory commitments
and brand strategy supporting key medical marketing messages in
partnership with commercial, regulatory, and clinical affairs
Medical/scientific training of all relevant
internal (e.g., marketing, sales, medical information) and external
parties (e.g. speaker training) regarding the brand
Works closely with the commercial team to
help build awareness of products in the medical community
Cultivate key opinion leader relationships
and provide clinical leadership in interactions with key opinion
leaders, advisory boards, patient advocacy groups
Support the communication of scientific and
medical information, specifically the presentation of key data to
the medical community via advisory boards, national and
international meetings, and other scientific venues.
Provide support for the publication strategy
and active involvement in the development of publications
Provide clinical leadership in the evaluation
and management of investigator initiated proposals and development
of a process
Requisite Skills:
Specific skills needed include:
MD or DO required with board
certification/eligibility or equivalent in Dermatology
Medical marketing experience is a plus
Excellent written and verbal communication
skills
At least 2 years experience in a
clinical/medical or industry setting
Good
understanding of strategic marketing acquired by experience or
formal training
Capabilities:
Needed
capabilities include:
Strong computer
literacy skills (including Word, Powerpoint)
Attention to detail
Effective planning (time and project management) skills
Strong interpersonal, negotiation,
communication, and problem solving skills
Proven ability to work well in cross-functional teams
Proven ability to form credible relationships
with national opinion leaders, especially in the field of clinical
dermatology |
| |
Salary: to 175K + Bonus, Job Type: Permanent, Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Redwood City, CA |
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| Job ID: |
DS-09247-2 - Associate Research Scientist |
| Description: |
This Company, located in Tarrytown, NY, is a
biopharmaceutical company focusing on the development and
commercialization of innovative therapeutic products to treat the
unmet medical needs of patients with debilitating conditions and
life-threatening diseases. Principal programs are directed toward
gastroenterology as well as the treatment of HIV infection and
cancer.
They offer a
wide-range of opportunities for highly motivated employees, who set
their goals high, will find that the rewards may exceed their
expectations. Their vision for a bright and prosperous future sets
the stage for energetic, creative professionals to join us and
contribute to our success. They currently employ individuals with a
variety of backgrounds including scientific, clinical research,
manufacturing and regulatory. Their growth depends on developing and
energizing the talents of new and current employees.
Responsibilities:
Perform mammalian cell culture
Perform cell-based assays such as ADCC and CMC
Conduct characterization of monoclonal
antibodies via a wide range of biochemical assays such as ELISA,
SDS-PAGE, Western Blot, FACS, Biacore, SEC-HPLC
Play a lead hands-on role in evaluation and
selection of preclinical candidates of monoclonal antibodies for
product development
Conduct in vivo
xenograft animal studies
Precise and
accurate experimental record keeping
Write
investigations and charge reports when required.
Requirements:
Requires an MS/MA degree with 1-3 years
hands-on experience within a biopharmaceutical R& D
organization, and industry experience.
Experience in mammalian cell culture, antibody
evaluation and characterization including cell-based assays such as
ADCC and CMC.
Demonstrates technical
expertise in performing a variety of experimental techniques, and
designating routing experiments while troubleshooting basic
problems.
Requires strong interpersonal,
oral and written communication skills. Highly motivated, organized
and eager to learn.
Technical
Requirements:
Candidates must have hands-on experience in
cell culture and protein/antibody characterization (ADCC, CMC, FACS,
ELISA, SDS-PAGE) and industry experience
|
| |
Salary: 52-65K, Job Type: Permanent, Total Exp: 1-3 Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
TRS-02158-16 - Associate Vice President - Global
Therapeutic Area Head, On |
| Description: |
Description:
The
chosen incumbent shall be responsible for but not limited to:
- Building an effective Oncology area to
achieve business objectives.
- Providing
input and support Oncology business strategy with an enterprise-wide
perspective and contribute to its outcome.
- Responsible for organization and successful
operating of advisory boards as necessary.
- Making Oncology area decisions with an
organization-wide perspective.
- Act as a
role model teamwork/collaboration in decision making process with
respect to Oncology area decisions and process.
- Aligning business and Oncology area
objectives across multiple project teams, departments, functions,
and Eisai business units.
- Building a
national/international reputation for excellence within the Oncology
field.
- Oversight of the Oncology
Therapeutic Area Globally.
- Working
closely with marketing, business development and pre clinical
research groups.
Qualifications:
- MD
with training in Oncology.
- Minimum 10
years experience (including academic and industry).
- Minimum 2-3 years experience running a
Therapeutic area or equivalent group with responsibility for
multiple drug trials preferred.
- Proven
ability to effectively interact with pre-clinical groups on complex
scientific issues relating to the Oncology area required.
- Experience in entire clinical drug
development process, including FDA/EMEA filing and product launches
preferred.
|
| |
Salary: Open, Job Type: Permanent, Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
COR-04298-1 - Business Development Director |
| Description: |
Summary Market the companys research services
to the pharmaceutical industries.
Essential Duties and Responsibilities include
the following. Other duties may be assigned.
· Develop strategies for establishing
partnerships and business relationships to market services.
· Collaborate with internal departments (and
possibly external partners) in the development
and implementation of strategies, plans, and
business models.
· Seek out and researches
prospective projects through making phone calls, traveling,
attending conferences, and utilizing the
Internet.
· Manage relationships with
various prospects, clients, and partners in the pharmaceutical
industry.
· Provide
support to upper management in deal negotiations, contract
development, due
diligence, and other
business development projects.
· Provide
input to the management team on new product or service features to
be developed to
meet current and future
business needs.
· Provide guidance and
support to junior business development staff, if applicable.
· Research and learn all new emerging
technologies and trends.
· Comply with Good
Clinical Practices (GCPs).
· Behave in a
cooperative and constructive manner; follow all company policies,
state, local,
federal and other applicable
laws and guidelines; comply with any and all job-specific
requirements.
· Perform
other duties as assigned or needed.
Qualifications To perform this job
successfully, an individual must be able to perform each
essential duty satisfactorily. The requirements
listed below are representative of the knowledge, skill, and/or
ability required. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
Education and/or Experience Four year college
degree; or four years related experience and/or training; or
equivalent combination of education and experience.
Language Skills
Ability to read, analyze, and interpret general
business periodicals, professional journals,
technical procedures, or governmental
regulations. Ability to write reports, business
correspondence, and procedure manuals. Ability
to effectively present information and respond to questions from
groups of managers, clients, customers, and the general public.
Mathematical Skills
Ability to add, subtract, multiply, and divide
in all units of measure, using whole numbers,
common fractions, and decimals. Ability to
compute rate, ratio, and percent, and to draw and interpret bar
graphs.
Reasoning
Ability
Ability to solve practical problems
and deal with a variety of concrete variables in situations
where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written,
oral, diagram, or schedule form.
Computer Skills
To
perform this job successfully, an individual should have proficiency
with MSOffice products including Word, Outlook, and Excel.
Other Requirements
Less than 10% travel, usually within North
America.
Physical Demands The physical
demands described here are representative of those that must be met
by an employee to successfully perform the essential functions of
this job. Reasonable accommodations may be made to enable
individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regul | |