Assoc Director Clinical Research

4 weeks ago

Gaithersburg, United States Unicon Pharma Inc Full time
Job DescriptionJob Description

Description:

Location: Gaithersburg, MD, hybrid w/ up to 2 days remote per week

Duration: 12 months, contract to hire based on business needs and performance

Title: Global Clinical Operations Program Director

  • 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 globalclinical studies within a program covering all clinical program 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 crossfunctional 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.

Typical Accountabilities and Responsibilities (delegated by Sr GPD):

  • 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 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 practises 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.

Education, Qualifications, Skills, and Experience:

Essential:

  • University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
  • At least 10 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

Desirable:

  • 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

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