Associate
Director/DirectorProject Management
A pharmaceutical company located in Connecticut is seeking
a Associate Director/Director Project Management to
provide coordinated management to assigned programs
in order to achieve agreed upon project goals. The Associate
Director/Director Project Management reports to the
Executive Director of Project Management and works at
their direction to establish a project plan and manage
project activities according to that plan.
PRINCIPAL RESPONSIBILITIES
Work with the Executive Director PM and Functional Area
Representatives to manage Project Team activities to
achieve project objectives. Establish and maintain transparency
of project activities and status through the creation
and maintenance of key project documentation, including
tracking of performance against plan for all project
development activities and deliverables. Author and
maintain key project documents and manage changes. Key
project documents include the Project Team Charter,
Target Product Profile (TPP), Strategic Development
Plan (SDP), an Integrated Timeline, monthly program
meeting minutes, monthly reports at the Clinical Tracking
Meeting as well as presentations to R&D Operating
Committee and written quarterly updates. Decisions,
Issues, and Risks: Contribute business analysis and
insight into project decisions, issues, and risks. Support
issue escalation as needed through the ED PM to functional
areas and R&D Operations. As a core Team member,
lead regular performance against plan analysis and updating
(both formally and informally) to the ED PM and Functional
Area Representatives, including monthly & quarterly
reports, of project, financial, and timekeeping data.
Facilitate meetings, generate agendas, document outcomes,
and track action items. Provide monthly evaluations
of program spending versus plan (i.e. budget and latest
estimate) and timekeeping data.
Communication is a critical component of this job.
The Associate Director/Director Project Management has
primary responsibility for evaluating and communicating
the status of the program relative to agreed upon goals
and deliverables. The Associate Director/Director Project
Management regularly interacts with the Project Leader,
Core Team Members, Functional Heads and updates R&D
Operations. The Associate Director/Director Project
Management communicates outside (e.g. co-developers,
partners, licensors, CROs and external experts) in coordination
with Alliance Management as appropriate.
Requirements
Bachelors required; Advanced degree preferred. Minimum
of 10 years of drug development experience. Science
background, project management skills and MBA preferred.
Knowledge
Understanding of multiple therapeutic areas, comprehensive
knowledge of the drug development and commercialization
process, and active participation in drug development
teams. In-depth knowledge of the Project Management
discipline including project integration management,
scope management, time management, cost management,
quality management, human resource management, risk
management, and procurement management. Demonstrated
academic and/or experiential scientific knowledge including
but not limited to medicine, nursing, biology, biotechnology,
chemistry, pharmacology, pharmacy, toxicology, and/or
the physical sciences. Demonstrated academic and/or
experiential business knowledge including accounting,
finance, information systems, management, marketing,
organizational behavior, operations and business policy,
and quantitative methods. Knowledge, as demonstrated
through active participation, of evaluating a program's
Strengths, Weaknesses, Opportunities, and Threats (i.e.
SWOT analysis) and Net Present Value (NPV). Knowledge
of the regulatory approval process as demonstrated through
active participation in the planning and executing submissions
to regulatory authorities. Computer literacy is expected
including knowledge of project management systems and
applications (e.g. MS Project).
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Director/Senior
Director Alliance Management
Pharmaceutical company located in Northern New Jersey
area is seeking a Director/ Senior Director Alliance
Management. The director of alliance management will
be responsible for the product life cycle management
including contract negotiations, coordination with BD
of new product introductions, changes to the manufacturing,
as well as product deletions.
-Responsible for defining of business strategy for
products manufactured at third party and internally.
The strategy should follow the product life cycle and
should focus on customer service and financial results.
-Work with BD on identifying vendors and suppliers.
Negotiate and manage contracts for all finished products.
-Leads cost reduction program and operational improvement
efforts resulting in improved product gross margins.
-Responsible for the vendor relationship programs as
well as dispute resolutions. Works with Purchasing in
vendor management process.
Requirements:
Senior person with minimum 15 years of Pharma experience
necessary.
Knowledge of contract management and product lifecycle
required.
MS or MBA preferred.
Strong interpersonal skill and project management skills
needed.
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Project
Manager
A pharmaceutical company located in New York is seeking
a Biotechnology Project Manager to coordinate efforts
within the Technical Operations Biotechnology organization
to meet significant cross functional project goals and
objectives for late stage biologics drug candidates.
The Project Manager will be responsible for translating
program needs into effective, detailed project plans
to meet business needs. The successful candidate will
lead major project teams to plan and execute projects
while interfacing with manufacturing, process development,
regulatory affairs, quality assurance, validation and
analytical staff.
The successful candidate will be responsible for development
of a detailed project plan including resource planning,
tracking project plan execution against established
targets, identifying and facilitating resolution of
issues, and communicating project status to team and
management. Additional responsibilities include defining
and executing risk management strategies, contingency
planning, and communicating solutions to management.
The candidate should exemplify behaviors that support
the development of a high performance team. The candidate
will develop an in depth understanding of biologics
manufacturing, CMC issues and the regulatory approval
process for late stage biologics drug candidates.
Position Requirements:
The successful candidate will have B.S., M.S., Ph.D.
in relevant science or engineering discipline or MBA.
A minimum of 6 years experience in a life science or
related discipline is required.
Must have a mastery of core and advanced project management
skills such as process flow analysis, facilitation,
coaching, financial analysis, change management, executive
alignment and results delivery.
Effective verbal and written communication skills are
essential. Experience in project management leadership
roles is desired. Knowledge of biologics regulatory
approval processes such as BLA, Pre license inspection
is a plus.
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Project
Management
A pharmaceutical company located in New Jersey is seeking
a Project Manager to prepare equipment and service quotations
including man hour estimates and purchased item costs
for all products and services. Process equipment orders,
develop and maintain project schedules, monitor project
budgets and review/approve all order design documents
for manufacturing. Travel up to 15% to customer sites
to perform project coordination. Act as main customer-project
liaison.
JOB RESPONSIBILITIES:
1. Overall responsibility for the budget, schedule,
problem resolution, and customer satisfaction for assigned
projects.
2. Assume lead customer interface for project from quote
to conclusion of warranty period.
3. Creation of project milestone schedules with tracking,
updating, and reporting.
4. Creating budgets, tracking and reporting final budget
versus actual costs
5. Expediting, obtaining change order approvals, and
tracking change orders
6. Obtain customer sign-off on project completion
7. Review performance of assigned project personnel
with regard to schedule, budget, and overall customer
service performance. This will be passed on to the individual
and their supervisor/manager to be part of their overall
performance review.
8.Organizing and maintaining project work files including
equipment specifications and purchase orders, faxes/quotes
from all vendors, pricing spreadsheets established for
U.S. and foreign supplied equipment, customer/vendor
correspondences, and all pertinent information.
9. Coordination of quotation development.
oPrepare project estimates and quotations including
manpower, purchased items, and purchased services. Prepare
project quote text. Personal responsibility for quotation
accuracy in all areas.
oSolicit the services of other departments during quote
preparation when the scope or technical complexity warrants.
oCoordinate with sales during quotation preparation
and when commercial issues arise during project execution.
10. New machine sale project responsibilities including
(but not limited to) the following responsibilities:
o Development of final specification packages.
o Instruct input of all TenRox job codes for project
labor tracking.
o Final specification package distribution and review
with Sales, Engineering Services, Process Automation,
Turnkey engineering and sub-vendors.
oDevelop final equipment specifications for all purchase
orders. Write up and place purchase orders with all
overseas and domestic vendors.
oDirect layout drawing development to overseas companies.
Submit drawing for customer approval.
oReceive vendor drawings/submittal packages in-house
for all purchased orders. Review for correct technical
and commercial accuracy. Oversee customer requested
changes on drawings are completed by the vendors. Track
approval process to stay on delivery schedule.
oMonitor manufacturing and delivery schedule for all
parts purchased. Alert Project Team of delivery problems.
oAct as main Technical contact for project mechanical
issues/items. Direct customer to Automation for controls.
oField customer requests for change orders. Issue change
order quotations with delivery and price impacts. Monitor
quote change order approval process. Issue Finalized
and Approved, Revision quotation to project team with
instructions. Issue internal purchase order change order
forms. Modify parts orders or place new orders for change
parts.
oReceive delivery, inspect, and oversee final shipment
of all parts brought in house for orders.
oCoordinate field start up schedules and manpower availability
with services manager.
oCoordinate all validation efforts/scheduling.
oComplete final start-up billing for accounting invoicing.
11. Lead kick-off and routine project meetings. Ensure
entire project team has current budget, schedule, and
scope clearly defined.
12. Review project costs (purchase orders, expense sheets,
time sheets, etc.) to assure that every effort is being
made to maintain a project's profitability.
13. Coordinate the various technical disciplines within
organization as applied to assigned projects.
14. Travel to customer and vendor sites for technical
meetings, quote reviews, and project coordination.
15. Issue accurate, timely and consistent documentation
related to all verbal conversations, submittals, project
meetings, etc.
16. Complete weekly TenRox time sheets for all projects
and workload.
17. Keep up-to-date on current product lines.
18. Perform other duties as assigned by management
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Project
Managerment/Scientific Affairs Coordinator
A growing mid-west CRO company is seeking a Scientific
Affairs Coordinator for coordinating and managing multiple
projects and tasks per established timelines and with
minimal supervision. Oversees teams to appropriately
assign project duties and continually monitor timelines,
workloads and project efficiencies. Provides hands on
technical expertise to supplement team functions when
needed. Works with the teams to analyze and evaluate
data. Responsible for ensuring compliance with overall
study objectives. Develops and actively manages the
scope of work, resource allocation (human and material),
objectives & timelines, and other project management
activities. Assume primary/lead responsibility for the
execution of assigned projects within operating budgets.
The coordinator serves as the communications liaison
with various internal departments and alliances.
Essential Duties and Responsibilities
- Provides strategic focus across projects to ensure
quality and timelines
- Facilitates communication within teams, across departments,
between sites, and with Sponsors as appropriate
- Provide weekly/monthly project progress to Scientific
Affairs management and executive management
- Lead the planning of projects, timelines, budgets,
and resource allocation. Create/maintain project plans
and timelines. Monitor progress to ensure timelines
are met. Oversee preparation of all project deliverables
and insure project documentation is maintained
- Collection and analysis of project milestone results
and timeline slippage to determine root causes; develop
and implement corrective action plans
- Assists team members in developing, maintaining, working
and updating project plans
- Contribute to the development of project staff through
mentoring, teaching and formal activities to achieve
project goals and lead individuals toward their development
goals
- Measure performance and track project progress
- Ensuring appropriate level of communication with managers
and team members
- Implements continual improvement through additional
training and development of processes. Initiate improvements
to enhance the efficiency and the quality of the work
- Define and manage project resource needs and establish
contingency plans for key resources; design, implement,
track, and revise project plans
- Promote effective teamwork; ensure that all staff
allocated to assigned projects. Adhere to professional
standards and SOPs established for clinical research.
Provide performance feedback to team members of respective
department heads; resolve conflicts as needed
- Lead projects/initiatives aimed at advancing capabilities
from study initiation through close
- Manage project budgets to meet financial and company
goals
- Evaluate the probability and impact of risks and develop
plans for minimizing their impact on the projects
- Offer input to proposals and budgets
- Review and approve required study documentation
- Manage client expectations, noting and respond to
out-of-scope work
- Interact with the client, programmers, data entry,
and statisticians to obtain corrections and ensure the
completeness and finalization studies
- Maintain knowledge of FDA guidelines, procedures and
SOP's. Adhere to all applicable company policies
- Write, revise and review SOP's and controlled forms
related to area of responsibility
- Maintain records of Key performance indicators
- Responsible for planning and implementing projects
delivering accurate, timely, consistent, and high quality
clinical data
- Identify and implement solutions to project management
issues and concerns including proactive prevention strategies
based on metrics and forecasts
- Serve as the project and client liaison including
provision of project specific status, cycle time, and
productivity metrics
- Maintain project management competencies via participation
in internal and external training seminars
- Identify and develop or implement new processes to
increase efficiency in all project activities
- Ensures communication with the study team/Sponsor
as needed regarding SA related project issues
- Performs all duties in accordance with SOPs, government
regulations and GXP's
- May perform other duties as assigned
Requirements
- Customer focused - Must be dedicated to meeting the
expectations and requirements of internal and external
customers; gets first-hand customer information and
uses it for improvements in products and services; acts
with customers in mind; establishes and maintains effective
relationships with customers and gains their trust and
respect.
- Directing Others - Is good at establishing clear directions;
sets stretching objectives; distributes the workload
appropriately; lays out work in a well-planned and organized
manner; maintains two-way dialogue with others on work
and results; brings out the best in people; is a clear
communicator.
- Planning - Must be able to accurately scope out length
and difficulty of tasks and projects; set objectives
and goals; breaks down work into the process steps;
develops schedules and task/people assignments; anticipate
and adjust for problems and roadblocks; measures performance
against goals; evaluates results.
- Peer Relationships - Can quickly find common ground
and solve problems for the good of all; can represent
his/her own interests and yet be fair to other groups;
can solve problems with peers with a minimum of noise;
is seen as a team player and is cooperative; easily
gains trust and support of peers; encourages collaboration;
can be candid with peers.
- Problem Solving - Uses rigorous logic and methods
to solve difficult problems with effective solutions;
probes all fruitful sources for answers; can see hidden
problems; is excellent at honest analysis; looks beyond
the obvious and doesn't stop at the first answers.
- Must be detail-oriented and possess strong organizational
skills and the ability to prioritize multiple tasks/projects.
Ability to handle multiple competing priorities and
to work independently.
- In-depth understanding and experience of project management
tools and processes
- Ability to facilitate conflict resolution
- Communication/presentation skills, oral & written,
with peers and with senior management
- Understanding of the global development process
- Bachelor's (life science preferred) degree or equivalent
in a related field of study or certification in a related
allied health profession from and appropriately accredited
institution (e.g., nursing certification, medical or
laboratory technology). Master's or advanced degree
preferred. Minimum of 5 years experience in the pharmaceutical
or CRO industry including project management experience.
- In-depth working knowledge regulatory, ethical requirements
and international guidelines for clinical research
- Computer literacy, proficient in MS Office, Project,
PowerPoint
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Senior
Project Management
Senior Project Manager
A pharmaceutical CRO in New Jersey is seeking a Project
Manager for the overall responsibility of the life cycle
of clinical research projects. The Senior Project Manager
will effectively lead the project team, ensuring on-time,
within budget, quality performance and delivery of projects.
Responsibilities:
Function as primary liaison between sponsor and staff
and as primary contact for project issues, including
the planning and execution of protocol-specific deliverables
and managing of budgets.
Establish objectives and strategies to direct activities,
evaluate capabilities, plus track, measure, and report
the status of project milestones.
Oversee day-to-day activities of team members; work
closely with sponsor team members to ensure timely and
accurate reporting of critical information.
Identify critical project tasks/issues and recommend/implement
courses of action to expedite project objectives.
Review and update revenue projections based upon project
plan and proposal fees; trigger invoicing processes;
initiate change-in-scope amendments.
Conduct regular Project Team Meetings including distributing
action items with assignments and due dates.
Review business development proposals.
Travel locally and nationwide as needed.
Qualifications:
- B.S. degree in nursing, pharmacy, or the life sciences;
advanced degree preferred.
- Minimum of 3-5 years related experience in the pharmaceutical
industry or a CRO including project management as well
as staff supervisory expertise.
- Thorough knowledge of the pharmaceutical clinical
drug development process and team-based matrix management
- Thorough knowledge of Good Clinical Practices (GCPs).
- Ability to effectively manage client relationships
and client expectations.
- Ability to effectively guide and lead teams to achieve
desired results within timelines and budget commitments
- Ability to manage multiple tasks concurrently
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Associate
Project Manager I
Pharmaceutical company located in Northern NJ is seeking
an Associate Project Manager I to be responsible for
leading project teams and managing cross-functional
activities for a portfolio of projects through the drug
development process including regulatory submission,
product approval and launch. Projects include but are
not limited to new product launches, scale-ups, alternate
API sources, site changes, external product integration
and business development opportunities. The project
manager tracks and reports progress, identifies risks
and provides expertise to resolve project difficulties
to meet project deadlines required to effectively deliver
products to market.
The project manager builds effective client and team
relationships. Competence is demonstrated by managing
the project plan, the assigned resources, reviewing
financial forecasts and the project activities. This
individual will serve as key contact person for internal
and partnered project-related issues and is accountable
for successful delivery of the project.
Essential Duties and Responsibilities:
Ensure that key development milestones are achieved
and that the project is progressed in a timely manner
for successful product launch.
Manage client relationship and ensure that good communications
are maintained
Evaluate the probability and impact of risks and develop
plans for minimizing their impact on the project.
Conduct team meetings/teleconferences provide agendas,
issue minutes with follow-up actions identified.
Maintain awareness of current market conditions and
competitive products.
Education and/or Experience:
Bachelors Degree with 3-5 years relevant industry/pharmaceutical
experience, or equivalent.
To perform this job successfully, an individual should
have:
Knowledge of drug development and experience with the
product launch process.
Must be proficient in communicating and interacting
with all levels of management as well as outside organizations.
Excellent, planning, organizational, written and verbal
communication skills required
Demonstrated ability to lead project teams cross-functionally,
manage multiple priorities in a challenging environment,
and demonstrated innovation/creativite
Experience within Sales, Sales Operations, Finance or
Marketing departments a plus
Proficiency in Microsoft Office Suite (MS Word, Excel,
Power Point) required
Knowledge of Microsoft Project required
Proficiency in Primavera Project Planner strongly preferred
Overnight travel as required
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Project Manager/Senior
Project Manager, Project Management
Pharmaceutical company located in Maryland seeks a
Project Manager/Senior Project Manager, Project Management.
The Corporate Project Manager/Senior Project Manager
will provide project management leadership to cross-functional
product development teams, function as a key interface
in global strategic alliances (alliance management),
and play an integral role in the strategic planning
process.
The position will integrate, facilitate, coordinate,
and manage all activities related to planning, executing,
and monitoring product development programs throughout
the entire product lifecycle. This will include the
creation and execution of integrated product development
plans and monitoring compliance with contract terms.
The incumbent will also assist in managing the product
portfolio by leading the development of business assessments
and project documentation that ensures alignment of
development programs with corporate objectives. The
candidate will be expected to play a key role in facilitating
strategic planning and risk assessments, and recommending
courses of action for business process improvements
and supporting infrastructure.
Demonstrated project management and integrated project
planning skills. Strong analytical skills with a working
knowledge of the biological sciences and pharmaceutical
product development (from concept to launch). Effective
matrix team building, facilitation, negotiation, and
management skills. Expertise in building business cases,
strategic planning, and aggregate portfolio planning
(including financial modeling, revenue projections,
etc.). Demonstrated successful experience working on
complex, cross-functional project teams. Cross-functional
drug development experience (i.e., in more than one
functional expertise) is beneficial. Computer skills,
including MS Office Suite and database and project management
software. Excellent communication (oral and written)
and interpersonal skills. Strong organizational skills
required; including good time management skills. Must
be highly organized and able to work independently on
multiple tasks in a fast-paced environment. Must be
professional, dedicated, and detail-oriented.
A B.S./B.A. in the Biological Sciences or equivalent
work experience is required. Advanced degree, at an
MBA or MS-level, preferred.
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Director,
Product Development
A pharmaceutical company in Massachusetts seeks a Director,
Product Development to be responsible for leading cross-functional
teams tasked with development of strategy, plan and
budget and execution of project plans. Leading the team
generally includes gathering input and facilitating
trade-off decisions with project management, sub-team
leaders for CMC, Pre-clinical, Clinical, Manufacturing,
and functional representatives from Quality, Regulatory,
Finance, IP, Business Development/Marketing.
The Candidate will ultimately be responsible for the
project plan assumptions and integrated development
plan. A key aspect of which is identifying and managing
pinch points in the plan and key areas of focus for
the cross-functional team.
The Candidate is responsible and accountable for the
project budget and communicating the budget and any
significant changes to the budget over the course of
the budget year to our management and our partners.
This includes final 'sign-off' on any invoices to alliance
partners.
The project team and Director are responsible for decisions
within the scope of the project plan. Must be able to
threshold certain decisions that have the potential
to more broadly impact the company and escalate to upper
management.
The ideal Candidate will be responsible for ensuring
good communication with partners for partnered programs
and for working closely with co-project leaders from
partner companies.
Minimum Education & Experience Requirements:
PhD and 5-10 years industry experience in product development
and cross-functional leadership (or a masters plus 10-15
years relevant industry experience)
Small Molecule, peptide, protein and other macromolecule
drug particles experience using sustained-release systems
required.
Knowledge/Skills Needed:
Excellent communication and negotiation skills, established
track-record as a Team player and the ability to assimilate
complex, multi-disciplinary inputs / data and come to
decisions with the ability to make strategic recommendations
to take to management
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Outsource Manager
A pharmaceutical company located in Connecticut is
seeking an Outsource Manager. The primary responsibilities
of the Outsource Manager will be to manage the overall
contracting and outsourcing strategy, at a project level,
for Research and Development. The main responsibilities
are to manage the selection of and contracting with
contract research organizations (CROs), and vendors
involved in clinical research activities. The incumbent
must communicate project issues and progress regularly
to the Project Teams and functional area management.
PRINCIPAL ACCOUNTABILITIES
1. Oversee various aspects of contracting and outsourcing
for the project teams and supporting departments. Coordinate
with functional departments to understand services and
deliverables required from outside vendors.
2. Coordinate with functional groups to develop Request
for Proposal specifications including operational assumptions,
quality measures, task lists and timelines.
3. Analyze service provider proposals and prepare recommendations
to facilitate development team's selection of appropriate
vendors. Evaluation includes cost analysis, capability
assessment, and overall alignment of services with project
goals.
4. Chair proposal defense meetings and coordinate all
follow-up activities with service providers during the
evaluation and selection process.
5. Forecast and report program and project level budget
estimates. Develop investigative site budgets and exhibits
based on project level budgets and final protocols.
6. Manage CRO deliverables, including but not limited
to: Clinical Trial Agreement approval and periodic audits,
grant budget review and approval and CRO budget reconciliation.
7. Provide structured, comprehensive, and timely reports
of the status of requests for proposals, vendor qualification
activities, budget negotiations, and contracting.
8. Address CRO and vendor invoice issues until resolved.
9. Create and maintain purchase orders for CROs and
vendors.
QUALIFICATIONS
Minimum Requirements
Bachelor's Degree in business or science, or equivalent
education.
A minimum of 4-6 years previous experience in clinical
drug development or equivalent experience/education
combination.
As part of the 4-6 years, experience, a minimum of 2
years of previous clinical contracting experience in
the pharmaceutical or related industry (e.g. Biotechnology,
Medical Device, Contract Research Organization) is necessary.
Strong negotiation skills.
Strategic planning and pro-active thought processing.
Ability to analyze drug development proposals.
Excellent organizational, interpersonal and oral/written
communication skills are required.
Ability to prioritize, multi-task and work as part of
a team.
Technical proficiency with the entire Microsoft Office
suite, as well as the ability to learn and utilize new
software (i.e. SAP).
Requires the ability to prepare contracts and RFPs
for programs in the most efficient and effective manner
within a constantly changing environment. This involves
planning, organization, communication, management and
leadership skills to coordinate program personnel, and
various service groups, and to understand the complexities
of clinical research processes, regulatory issues, resource
allocation, and scheduling issues in order to aid in
the selection of the most desirable provider.
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Director Oncology, Project Management
A pharmaceutical company in southern California is growing
its Project Management division and is currently seeking
a Director of Oncology Project Management. . This individual
will manage and direct the activities of the core project
groups associated with the company's oncology development
program including discovery, pre-clinical, toxicology,
manufacturing, R&D, QA, QC, clinical development,
etc. The Director will manage the overall project plan,
including all internal and external resources, and facilitate
and lead cross-functional teams, which includes accountability
for timeline management and adherence to schedules to
meet project objectives. The director will communicate
problems and issues as a result of technical and resource
constraints, and collaborate with team members to not
only provide solutions to those problems but also to
develop proactive preventative measures to avoid such
problems in the future. This is a highly visible position,
which will require regular interaction throughout the
organization
Qualified candidates must have prior experience directing
the lifecycle of oncology drug development projects,
along with demonstrated leadership in similar positions
managing cross-functional project teams. Must have the
ability to be a hands-on, self-starter, with results-oriented
style. Must be able to interact at all levels of the
organization with dynamic motivational skills to successfully
encourage teams to excel. Excellent communication skills.
Capable of managing multiple projects. Knowledge of
and experience in the pharmaceutical regulatory environment,
including GLP, GMP and GCP as outlined in ICH Guidelines
and the Code of Federal regulations. Requires a BS/MS
degree in scientific discipline, plus seven years of
drug development project management experience or a
Ph.D. with four years experience within the pharmaceutical
or biotechnology industry, in a similar role. MBA a
plus.
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Vice
President, Product Development
A pharmaceutical company in Massachusetts seeks a Vice
President, Product Development to be responsible for
leading cross-functional teams tasked with development
of strategy, plan and budget and execution of project
plans. Leading the team generally includes gathering
input and facilitating trade-off decisions with project
management, sub-team leaders for CMC, Pre-clinical,
Clinical, Manufacturing, and functional representatives
from Quality, Regulatory, Finance, IP, Business Development/Marketing.
The Candidate will ultimately be responsible for the
project plan assumptions and integrated development
plan. A key aspect of which is identifying and managing
pinch points in the plan and key areas of focus for
the cross-functional team.
The Candidate is responsible and accountable for the
project budget and communicating the budget and any
significant changes to the budget over the course of
the budget year to our management and our partners.
This includes final 'sign-off' on any invoices to alliance
partners.
The project team and Vice President are responsible
for decisions within the scope of the project plan.
Must be able to threshold certain decisions that have
the potential to more broadly impact the company and
escalate to upper management.
The ideal Candidate will be responsible for ensuring
good communication with partners for partnered programs
and for working closely with co-project leaders from
partner companies.
Minimum Education & Experience Requirements:
PhD with a scientific background and 10+ years industry
experience in product development and cross-functional
leadership.
Knowledge/Skills Needed:
Small Molecule, peptide, protein and other macromolecule
drug particles experience using sustained-release systems
required.
Excellent communication and negotiation skills, established
track-record as a Team player and the ability to assimilate
complex, multi-disciplinary inputs / data and come to
decisions with the ability to make strategic recommendations
to take to management
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Director
Project Management
New Frontier
A well known global branded pharmaceutical company in
New Jersey seeks a Director of Project Management to
be responsible for project management and planning for
new drugs from there global facility. This highly visible
position is responsible for building the department
including hiring the Sr. Managers, establishing systems,
SOPs and procedures. Participate in teams in order to
establish programs that are aligned with clinical development
plan timelines. Define project vision and strategy for
achieving the company's vision. Engage and motivate
teams to execute project strategies. Provide guidance
and oversight to project teams and project managers.
Ph.D preferred in Life Sciences or biomedical science
required. Minimum 8 years relevant experience in project
management in the pharmaceutical industry. Experience
leading cross-functional teams and various therapeutic
areas. Prior experience with US, Europe and Japan. Strong
analytical problem solving skills are essential. Candidates
with proven strong leadership skills.
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Senior
Clinical Project Management
A pharmaceutical CRO in New Jersey is seeking a Project
Manager for the overall responsibility of the life cycle
of clinical research projects. The Senior Project Manager
will effectively lead the project team, ensuring on-time,
within budget, quality performance and delivery of projects.
Responsibilities:
Function as primary liaison between sponsor and staff
and as primary contact for project issues, including
the planning and execution of protocol-specific deliverables
and managing of budgets.
Establish objectives and strategies to direct activities,
evaluate capabilities, plus track, measure, and report
the status of project milestones.
Oversee day-to-day activities of team members; work
closely with sponsor team members to ensure timely and
accurate reporting of critical information.
Identify critical project tasks/issues and recommend/implement
courses of action to expedite project objectives.
Review and update revenue projections based upon project
plan and proposal fees; trigger invoicing processes;
initiate change-in-scope amendments.
Conduct regular Project Team Meetings including distributing
action items with assignments and due dates.
Review business development proposals.
Travel locally and nationwide as needed.
Qualifications:
o B.S. degree in nursing, pharmacy, or the life sciences;
advanced degree preferred.
o Minimum of 3-5 years related experience in the pharmaceutical
industry or a CRO including project management as well
as staff supervisory expertise.
o Thorough knowledge of the pharmaceutical clinical
drug development process and team-based matrix management
o Thorough knowledge of Good Clinical Practices (GCPs).
o Ability to effectively manage client relationships
and client expectations.
o Ability to effectively guide and lead teams to achieve
desired results within timelines and budget commitments
o. Ability to manage multiple tasks concurrently
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Associate Director, Project Management, Oncology
A well known global branded pharmaceutical company
in New Jersey seeks an Associate Director to assist
in the global development of oncology compounds by interfacing
with the oncology therapeutic area and global team members
in clinical pharmacology, clinical operations, regulatory
affairs, data management, statistics, finance, and medical
writing.
Through team leadership will plan, direct, and coordinate
activities of designated oncology projects to ensure
objectives of these projects are accomplished within
the prescribed time frame and funding parameters. Substitute
for the IPTL in meetings and discussions within and
in meetings with Investigators and CRO's, if needed.
Guide the teams and assist in the preparation and review
of documents that include, but are not limited to IBs,
contracts, CDPs, protocols, and study reports. Develop
and implement procedures for monitoring projects, such
as regularly leading oncology team meetings to monitor
progress, follow-up on team actions, identify new actions
and potential issues and agree upon resolutions. Prepare
meeting minutes and progress reports, hold staff conferences
to inform management of the current status of each project.
Qualifications
Masters or Ph.D in biomedical science preferred. 8
years experience working in project management capacity
in the pharmaceutical industry. Experience leading cross
functional teams and managing multiple projects.
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