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Global Clinical Operations Program Director

1 month ago

Gaithersburg, United States Rangam Full time

Pay rate: $84 - $94 per hour


  • 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 programsalign 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 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