Company
ClinicalDirector
Neural analysis suggests this role is
optimal for Director candidates.
“Clinical Director. Skills: Clinical program leadership, Clinical study management, Staff development. Provide global/regional leadership. Ensure high quality clinical studies”
Industry & Context.
Analysis of situations; Analysis of data
25% travel
What They're Looking For.
Must Have
10+ years experience clinical/scientific research, 10+ years experience nursing, 10+ years experience medical devices/pharmaceutical clinical trials
Nice to Have
5+ years experience managing projects, 5+ years working with clinical professionals, 5+ years cross-functional product development, Degree in science/health related field, PhD-level degree or equivalent, Qualification in medicine
What You'll Do.
Provide global/regional leadership
Ensure high quality clinical studies
Manage clinical project team members
Oversee project timeline development
Interface with data management
Interface with biostatistics
Interface with clinical research associates
Interface with medical directors
Interface with functional management
Liaise with investigators
Liaise with clinical site staff
Be accountable for concurrent clinical studies
Leverage resources across projects
Develop staffing plans
Develop clinical staff
Mentor clinical staff
Supervise clinical staff
Participate in global clinical strategies
Assist in global clinical strategies
Support regulatory/clinical strategies
Oversee preparation of budgets
Oversee management of budgets
Negotiate contracts with sites
Negotiate budgets with sites
Negotiate contracts with vendors
Negotiate budgets with vendors
Review final study conduct documents
Approve final study conduct documents
Draft instructions for use
Review instructions for use
Approve instructions for use
Attend investigator meetings
Attend coordinator meetings
Provide oversight of clinical trials
Ensure safety concerns identified
Ensure adverse events identified
Develop appropriate responses
Execute appropriate responses
Provide advice on reportability
Determine membership criteria
Identify potential members
Approve trigger plans
Manage data release meetings
Manage review meetings
Participate in finalizing manuscripts
Participate in approving final reports
Participate in dissemination of clinical information
Review corrective action plans
Approve corrective action plans
Participate in study-related audits
Develop Clinical Affairs infrastructure
Maintain Clinical Affairs infrastructure
Draft Divisional Work Instructions
Review Divisional Work Instructions
Draft local Instructions
Review local Instructions
Demonstrate knowledge of clinical research conduct
Coach others in clinical research conduct
Ensure compliance with company SOPs
Ensure compliance with company policies
How You'll Work.
Team & Collaboration
Cross-functional product development; Clinical team members; Extended core team members
Communication Scope
Company liaison; Representing the region
Process & Methodology
Clinical project management, Timeline development, Budget management
Full Job Description
## **JOB DESCRIPTION:** **Primary Function** Provides global or regional leadership for a particular regional or global clinical program. Ensures design and execution of high quality clinical studies to ensure safety and effectiveness of the company’s products. Manages clinical project team members to appropriate and timely completion of projects; oversees project timeline development and maintenance. Internally interfaces with data management and biostatistics, clinical research associates, medical directors, functional management, and acts as a company liaison with investigators and clinical site staff. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. **Major Responsibilities** * Responsible and accountable for several concurrent clinical studies for multiple programs and therapeutic areas. * Leverages resources, expertise, and knowledge across projects to ensure deliverable attainment. Develops staffing plans to appropriate align resources to workloads. * Hires, trains, develop, mentors, and supervise managers and clinical staff. Develops staffing plans. * Participates in and assists in the development of global clinical strategies for assigned therapeutic area(s) working in collaboration with regulatory affairs, marketing, research & development, reimbursement and outcomes planning, and regions to obtain approvals by the most effective method possible. * Supports regulatory/clinical strategies as the clinical representative for the therapeutic area or region. * Oversees the preparation and management of budgets for projects in therapeutic area. * Negotiates contracts and budgets with sites and vendors. * Reviews and approves protocols for projects; reviews final study conduct documents such as study manuals, study tools, etc. * Drafts, reviews, and approves instructions for use for investigational devices. * Attends investigator and coordinator meetings, representing the region. * Provides oversig
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