Director Clinical Operations

Job Title: Director/Senior Director, Clinical Project Management

Position Overview

The Director/Senior Director, Clinical Project Management will be responsible for the oversight, management and delivery of clinical development programs of multiple products conducted by the company. The responsibilities of this position may include supporting the development of documents for clinical research studies, including protocols, informed consent documents, case report forms, in collaboration with other corporate functions, line management for selected clinical operations staff, and execution of the clinical development strategy including development of clinical trial documents, selection and training of study sites, oversight of study conduct, data review and assembly of clinical study reports. This position will also be managing clinical outsourcing, overseeing financial and budgetary aspects of clinical trials and will provide input into resourcing of assigned clinical projects.

Essential Duties & Responsibilities

Key responsibilities of this role include, but are not limited to:

• Provides a leadership role in managing multiple clinical research trials across all functional areas involved in the drug development process.
• Oversees and coordinates all operational aspects of clinical trials to ensure corporate goals of time, cost and quality performance expectations are met.
• Develops clinical research protocols and other clinical trial-related documents (i.e., IBs, ICFs, CRFs, Pharmacy Manuals, Monitoring Plans, etc.).
• Selects clinical trials sites, proactively trains and supports site staff.
• Coordinates/facilitates regulatory submissions in support of clinical trial conduct.
• Identifies risks, mitigates, resolves and escalates as needed to address operational, compliance and/or other problems impacting trial progress/quality.
• Functions as lead advisor for site audits, including defining, scheduling, assessing, evaluating and resolving eventual outcomes.
• Ensures monitoring reports are critically reviewed and appropriate follow-up is performed through resolution.
• Plans and/or conducts site visits to help establish, assist, and evaluate operational execution of the study.
• Identifies requirements and develops bids for clinical research activity providers such as CROs, and other specialty vendors (e.g. central laboratories, visiting healthcare providers, data management, site oversight, monitoring, and other vendors as required).
• Strong outsourcing management oversight, including ability to develop statement of work, review technical contacts and review/negotiate complex financial budget proposals.
• Develops clinical study budgets, participates in ongoing financial forecasting, and performs reconciliation of invoices against planned spend.
• Coordinates on-schedule delivery of clinical trial supplies in collaboration with CMC function.
• Interviews, hires and trains clinical operations staff assigned to projects as required, and directs work, setting objectives, conducting performance appraisals, including rewarding and disciplining employees. Mentors clinical operations staff and makes recommendations for staffing needs.
• Supports the larger Clinical Operations organization by sharing lessons learned and supporting initiatives for process and business improvements.
• Attends and presents at external Investigator Meetings and CRO (or other vendor) meetings, and represents Clinical Operations on the company’s Project Teams.
• Authors and maintains SOPs and CAPAs, as applicable.
• Performs other duties, as required.

Qualifications

• Bachelor’s/Master’s Degree or higher strongly preferred in related scientific discipline (biology, nursing, epidemiology, public health, etc.) although exceptions may be made for highly qualified candidates with extensive work experience.
• Minimum of 12 years of relevant experience in leading and supporting all phases of clinical research, supporting US as well as international trials.
• Knowledge of pharmaceutical and regulatory requirements, procedures, and policies with a minimum of 10 years of pharmaceutical experience; experience preparing regulatory documents such as INDs and/or IMPDs is preferred.
• Knowledge of GCP, ICH, CFRs and other guidance documents and policies related to clinical trials operations requirements.
• Knowledge of all aspects of clinical drug development process (Phase 1-4).
• Excellent computer skills including Microsoft Office suite of software; strong verbal and written communication skills.
• Demonstrated ability to develop and negotiate budgets and resourcing models.
• Experience with US, EU, AP and international clinical research carried-out in developing countries.
• Experience implementing protocols in an international setting, providing training and overseeing clinical research studies are all desirable.
• Global perspective and mindset; ability to work effectively with colleagues from other cultures.
• Ability to competently manage a heavy workload and multiple competing priorities, switching priorities quickly as needs change. Must be comfortable, flexible and nimble working in a quick-paced environment.
• Demonstrated very high level of technical skill and expertise as it pertains to clinical research site support and development.
• Demonstrated high proficiency in project planning and management and proactively anticipate and identify complex issues and problems.
• Ability to work well in a team environment both as a leader and a contributor.
• Open, engaging, and transparent work style. Demonstrated exceptional interpersonal skills and written and verbal communication abilities.
• Ability and willingness to conduct essential business travel (internationally and domestically)