Director Clinical Research
Company: Fladger Associates
Posted on: September 24, 2022
Gaithersburg, MD or Durham, NC Contract Duration: 12-36 months
Rate: Negotiable Responsibilities:
- Excellent employment opportunity for a Director Clinical
Research in the Gaithersburg, MD or Durham, NC.
- Can be a hybrid situation with up to 50% remote work.
- Possibly open to remote/virtual arrangements for strong
candidates, but candidates must be within driving distance from
Gaithersburg or Durham and able to come onsite regularly for
- Renowned expert in own field and may specialize in more than
- Works independently with guidance in only the most complex
- May coordinate the activity of a research team and holds full
accountability for projects, often with Global impact.
- Will work in a global role within the Clinical Operations
function of Late Stage RandD (Biopharmaceuticals).
- The span of responsibilities is broad and may support one or
several products depending on their size and complexity.
- The products supported may include studies in all phases of
- Responsible for oversight of a program of global studies,
covering all clinical development deliverables (including aspects
of quality, budget, time, resource and risk).
- Also involves integrating design, feasibility and operational
planning to ensure clinical drug development programs are aligned
with priorities and strategy.
- Provide input and support to the Senior Global Clinical
Operations Program Director in preparation for new business case
opportunities for review by governance interactions and may act as
the lead for cross-functional teams in delivery of various clinical
activities and manage improvement or change projects within
clinical operations or spanning multiple business areas.
- Lead cross functional teams of experts in the planning and
delivery of a defined clinical program of studies and/or clinical
activities to scope, quality, budget, time, planning the resource
and managing risk.
- Work closely with global study leaders to provide appropriate
strategic oversight of a program of studies on behalf of Sr Global
Clinical Operations Program Director and Clinical Program Team
- Responsible for providing clinical operations expertise into
the development of new business case opportunities for review by
- Lead cross functional Clinical Submission Teams in planning and
execution of clinical contribution to Marketing Applications,
maintenance support for regulatory interactions and reports and
- Lead large or complex deliverables and the process to identify
and solve or raise operational issues.
- Drive delivery to plan through internal or external partners
(alliance partners, Clinical Research Organizations (CROs), vendors
and Academic Research Organizations (AROs)). Experience:
- Bachelor's Degree (or equivalent), preferably in Medical or
Biological Sciences or subject area associated with Clinical
- At least 10 years' experience from within the Pharmaceutical
industry or similar large multinational organization and proven
experience of clinical development / drug development process in
various phases of development and therapy areas.
- Experience from leading clinical projects and deliverables or
similar expertise from other areas of drug development (such as
Pharmaceutical development) and proven knowledge of project
management tools and processes.
- Proven leadership promoting motivation and empowerment of
others in order to accomplish individual, team and organizational
- Ability to mentor, develop and educate staff.
- Excellent written and verbal communication skills, negotiation,
collaboration and interpersonal skills. Job Requirements:BIOLOGICAL
SCIENCES, pharmaceutical, DRUG DEVELOPMENT, project management
tools, clinical research, clinical development, Medical
Keywords: Fladger Associates, Durham , Director Clinical Research, Executive , Durham, North Carolina
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