Vice President, Clinical Development
Burlington, MA

JOB SPECIFICATION

The Company

The Company is a biotechnology company pioneering the use of cell therapy for the treatment of kidney disease. The Company’s unique technology allows for the isolation and expansion of a specific population of mesenchymal stem cells obtained via conventional bone marrow donation. The Company’s cells are not recognized by the immune system enabling them to be administered in an off-the-shelf fashion to any patient in need.
The Company’s cell therapy stimulates organ repair which preserves and sustains kidney function. The Company has completed a phase 1 clinical trial and is now preparing for a phase 2 trial. This technology addresses a large unmet medical need and is the first cell therapy to treat kidney disease.
The Company is a privately held company with headquarters are located in Burlington, MA, with additional locations in Salt Lake City, UT and Hamburg, Germany.

The Position

The Vice President, Clinical Development reports to the President and Chief Executive Officer, and will serve as a member of the Company’s management team.

Professional Responsibilities

• Provides strategic direction on all operational aspects of clinical trials set-up, management and execution. Contributes to clinical development planning and trial design.
• Performs and/or directs study feasibility to optimize clinical trial execution.
• Determines costs and resources needed to execute clinical development plans.
• Ensures project key deliverables are met on time and within budget.
• Leads the establishment of clinical departmental processes, ensuring adherence to The Company's standards, and all applicable regulations and guidelines.
• Provides the technical and managerial leadership and organizational improvement of Clinical Operations.
• Manages staff and/or vendors/consultants, and provides assessment of training needs based on role description and project needs.
• Ensures that proper activities are undertaken for the timely and quality set-up, and planning of clinical studies.
• Leads the management and execution of clinical trials to meet The Company's corporate objectives.
• Manages interdepartmental scientific and medical activities specific to implementation and conduct of protocols.
• Reviews and approves clinical outsourcing specifications for RFPs
• Ensures adherence to The Company's SOPs, policies and all applicable regulations and guidelines.
• Ensures the collection of high quality clinical data; participates in the analysis of clinical data.
• Ensures departmental processes are efficient and comply with applicable regulatory requirements.
• Ensures proper and timely resolution of CQA audit findings.
• Ensures a high level of internal and external customer service for clinical study sites.
• As required, develops and maintains long-term relationships with key investigators, opinion leaders, other industry leaders.
• Sets departmental strategy for capacity management and help set departmental goals
• Participates in or leads change initiatives including process improvement efforts
• Stays abreast of latest developments in clinical trial management, drug development, and, where possible, contribute to advances in the field
• Promotes and communicates the role of the Clinical Operations department (internal/external; scientific/process)
• Plays a leading role in articulating the Company’s clinical-regulatory strategy.
• Leads or supports the completion of regulatory documents and submissions, including clinical efficacy and safety information.

Candidate Requirements

• 10+ years experience of progressively increasing clinical research/development experience within the pharmaceutical industry.
• Experience in drug development, especially FDA (& European) and local regulations and ICH-GCP.
• Profound experience in clinical trial management.
• An advanced degree (M.S. or PharmD) is preferred. A minimum academic degree in Nursing (R.N. or B.S.N.), Life Sciences (B.A. or B.S.), Pharmacy or Medicine required. Experience requirements may be less with advanced degrees.
• Experience in nephrology, biologics or cell therapy is an advantage but not required
• Excellent problem solving and communication skills, excellent team building skills.
• Excellent management & leadership skills
• Leading ability to deliver oral presentations and write in a clear, focused, and concise manner.