The Global Clinical Operations Program Director
Company: Alpha Consulting Corp.
Location: Gaithersburg
Posted on: May 28, 2023
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Job Description:
THE GLOBAL CLINICAL OPERATIONS PROGRAM DIRECTOR GAITHERSBURG,
MD100% Remote.Project Description: The Global Clinical Operations
Program Director (GPD) is a core global role within the Clinical
Operations function of Late-Stage R&D (BioPharmaceuticals and
Oncology). The span of responsibilities is broad and may support
one or several products depending on scope and complexity. The
products supported will be in Phase 3 development or on the market,
but the program may include studies in all phases of drug
development. On behalf of the Senior Global Clinical Operations
Program Director (Sr GPD), the GPD provides strategic operational
leadership and oversight of a suite of global clinical studies
within a program covering all clinical operations deliverables,
covering all clinical operations deliverables to scope, quality,
budget, time, resource, and risk, ensuring new innovative design
and delivery models are used appropriately. The role involves
integrating strategy, design, feasibility, and operational planning
to produce business-focused clinical drug development programs that
align with priorities and strategy. The GPD will develop the core
clinical operations components for governance interactions with the
oversight of the Sr GPD. The GPD may also act as the lead for
cross-functional teams in delivery of clinical program team (CPT)
activities assigned. The GPD may provide project leadership for
cross-functional clinical submission teams in support of regulatory
marketing applications and post-registration product maintenance
deliverables. Additionally, the GPD may lead or contribute to
improvement and change projects within clinical operations and/or
other 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 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 in 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 systems, 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 client's 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
lessons learnt . Be an early adopter for new ways of working and
act as ambassadors for change, driving the implementation and
utilization of new initiatives. Required Skills: 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 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 . Excellent
stakeholder management skills . Adaptability . 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 . This 12+month position starts ASAP.Please E-MAIL
your resume (attachment to email) with rate and availability to
Bridget: bridget@alphaconsulting.comALPHA'S REQUIREMENT
#23-00845MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2
EMPLOYEEPDN-99132213-3008-4104-bd65-a64b43b53941
Keywords: Alpha Consulting Corp., Washington DC , The Global Clinical Operations Program Director, Executive , Gaithersburg, DC
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