$190,000 - $250,000 a year

The Director of Clinical Operations will, in partnership with senior management at iota and Astellas, implement and manage early feasibility, proof of concept and pivotal medical device clinical studies to achieve the project and corporate objectives. This position will work with cross-functional team members, clinical research organizations, and consultants to ensure the successful, cost-effective, and timely execution of clinical studies.

Core Responsibilities: 

• Functions as the study lead in managing the clinical operations team and cross-functional clinical trial team in the planning, execution and reporting of clinical trials

• Manages external resources such as consultants, contractors, CRO’s

• Responsible for managing study budgets including forecast and invoice approvals

• Coordinates vendor meetings and reviews vendor documents (e.g., manuals, Master Service Agreements, contracts) for adequacy

• Develops project plans and schedules to include timelines, budgets and milestones

• Prepares and/or supports preparation of clinical documents (e.g., protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards), Standard Operating Procedures and guidelines

• Identifies and assists in departmental training requirements including internal and external operations

• Ensures all clinical activities are delivered in accordance with trial protocol, ICH/GCP guidelines and applicable SOPs and regulations

• Supervises direct reports and matrixed study team

• Operates at the highest level of iota/Astellas compliance and professional standards

Minimum Qualifications:

• Bachelor’s or RN degree

• Minimum 10 years of experience in Clinical Operations roles with minimum 5 years as a study manager or study lead at a medical device company with a keen understanding of all aspects of Clinical Operations, including clinical trial design, study implementation/ start-up activities, site management, data management

• Experience managing at least 1 successful CRO clinical trial

• Knowledge of GCP, ICH guidelines and FDA regulations

• Understanding of the principles of project management and proven ability to lead a project team

• Able to work in a fast-paced environment, well organized and self-directed

• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressures

• Adaptable and able to work in a work environment where priorities are constantly changing

• Ability to travel (Average travel expectations approximately 35%)

Preferred Qualifications:

• Medical device experience highly preferred

• Direct involvement in early phase human clinical trials.

• In-depth experience with early device development

• In-depth experience soliciting CRO and key vendor proposals, critically evaluating competing proposals, negotiating key terms, and selecting/initiating these relationships

• Experience in reviewing or writing of clinical protocols, study manuals, case report forms, and informed consent forms

iota Biosciences, a wholly-owned subsidiary of Astellas Pharma US, is a medical device company pioneering bioelectronic solutions across a range of medical therapies and diagnostics. Bioelectronic medical implants are the start of an entirely new form of medicine, treating chronic diseases through non-pharmaceutical mechanisms not previously accessible to clinicians.

iota Biosciences, Inc. was acquired by Astellas Pharma US in November 2020. Astellas Pharma US, Inc. is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. iota’s core proprietary technology stack leverages ultrasonic energy to communicate with and power custom implantable devices, enabling completely new clinical approaches to treating diseases. At iota Biosciences you will be given the opportunity to substantially influence the design and success of these pioneering Class III medical implants, as the company expands the reach of its novel technology while bringing new solutions to the clinic. At iota Biosciences, we take pride in providing equal employment opportunities to everyone, inclusive of race, ethnicity, beliefs, religion, marital status, gender, gender identity, citizenship status, age, veteran status or disability.

iota offers a very competitive benefits package that includes the following:

Health & Wellness

Comprehensive health coverage for you and your family, covered at 100%

Access to quality dental and vision

Onsite Gym in Alameda

Work-Life Balance

Generous vacation pay

Paid parental leave

Options for flexible work schedules

Competitive Compensation

Annual Bonus Plan

Long Term Incentive Plan (LTIP)

401k plan with employer match

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Director of Clinical Operations