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14 days old

Director Clinical Research

Kelly Services
Gaithersburg, MD 20898
Kelly is hiring for an **Director Clinical Research** position with one of our clients in **Gaithersburg, MD** .


+ 12 months contract (May be extended or converted)

+ $90-$95/hr


Job Description:


+ 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 GPD and Clinical Program Team (CPT)

+ Provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.

+ Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, quality, feasibility, risk)

+ On behalf of CPT, responsible for managing clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT

+ Lead large or complex deliverables and the process to identify and solve/escalate operational issues and drive delivery to plan through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)).

+ Act as the point of escalation for study teams for external (e.g. CRO) partners for externally managed/outsourced studies as appropriate

+ Responsible for leadership and program management of non-drug project work as assigned, e.g. cross functional improvement/change initiatives

+ Provide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package)

+ Lead cross-functional teams in delivery of assigned clinical program team (CPT) activities

+ Contribute to functional and cross-functional initiatives as Subject Matter Experts

+ Mentor, coach and support people development as appropriate.

+ Actively participate in networking both within and outside the therapeutic area, sharing best practices and lesson learnt

+ Be an early adopter for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives.


Qualifications and Education Requirements:


+ University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.

+ At least 10 years experience from within the pharmaceutical industry or similar large multinational organizations.

+ Proven knowledge of project management tools and processes

+ Proven experience in clinical development/drug development process in various phases of development and therapy areas.

+ Proven ability to learn by working in multiple phases, TAs, and/or different development situations.

+ Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).

+ Ability to mentor, develop and educate staff

+ Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives

+ Skilled & experienced in change management

+ Ability to look for and champion more efficient and effective methods/processes of delivering clinical operations components focusing on key performance metrics around reliability, productivity, cost and quality

+ Excellent stakeholder management skills


Preferred Skills:


+ Project management certification is desirable but not mandatory.

+ Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory

+ Regulatory submission experience

+ Proven knowledge of clinical operations,

+ Experience with development and implementation of digital health initiatives in Clinical Studies

+ Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization

+ Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a regional and local environment

+ Integrity and high ethical standards

+ Adaptability


\#P2


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-21 Expires: 2022-10-22

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Director Clinical Research

Kelly Services
Gaithersburg, MD 20898

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