Position Overview:

Outset is looking for a knowledgeable and passionate individual to lead our clinical affairs and operations efforts. Reporting to the Medical Officer, this role is responsible for determining and developing the clinical evidence required to support the use of Tablo across a range of clinical settings. The individual will work cross functionally with the commercial and product development teams, company clinical advisors and key opinion leaders in the market to develop evidence on clinical outcomes, improved user experience and reduced cost associated with adoption of Tablo.

The ideal candidate should be well versed in clinical research for medical devices in both the pre-market and post-market spaces, be naturally curious and a creative problem solver. He or she should be able to lead a diverse group and able to develop and deliver a clinical evidence plan with both internal and external stakeholders. Finally, he or she should be passionate about serving customer needs through innovative technology applications and want to be a part of creating a paradigm shift in renal replacement therapy.

Core Responsibilities:

• Develops and implements clinical strategy in support of Outset’s business objectives; including resourcing and timelines​
• Manages clinical affairs organization including career development and regular 1x1s; drives team towards the achievement of strategic priorities​
• Oversees the conduct of clinical trials to ensure compliance and alignment with overall strategy​
• Collaborates extensively with MA to execute publication pipeline and regulatory to support expanded indications and claims

Essential Job Functions and Responsibilities:

Program Management

• Develops clinical strategy and builds capabilities, resources, and processes for execution​
• Expands clinical program to meet the growing needs of the organization​
• Directly and indirectly oversees clinical trials to ensure compliance, accuracy, and alignment with business objectives​
• Proactively collaborates with MKTG, regulatory and MA teams to ensure alignment around claims and publications

Clinical Strategy

• Develop and manage the overall clinical evidence and publication strategy for the organization
• Drive and manage FDA submissions and communications
• Establish and approve of clinical design and implementation of clinical protocols, data collection systems, and final reports in both the pre-market and post-market spaces
• Identify appropriate investigators or study sites and support negotiation of clinical trial agreements, manage program budgets, and monitor adherence to protocols
• Interface with investigational sites, clinical consultants, Contract Research Organization, and other vendors

People Management

• Supports and coaches clinical affairs team members on career development; develops team for future growth within the organization ​
• Leads directly and indirectly across the organization ​
• Fosters integration and collaboration across teams​
• Successfully and strategically prioritizes programs and initiatives

Stakeholder Relationship Management

• Manages stakeholder relationships serving as point-of-contact clinical trial escalations and issues​
• Oversees overall program timelines and associated relationships​
• Manages internal and external stakeholder relationships as the key clinical affairs contact for Outset

• Partner cross-functionally with marketing, medical affairs, product development, sales, regulatory and other parts of the organization as needed to define the key clinical requirements, and developing execution plans

Required Qualifications:

• B.S. in engineering or life sciences, advanced degree (M.S., M.D., or PhD.) preferred
• Minimum of 8 years of progressive leadership experience across the design, management and evaluation of clinical studies and evidence development strategies
• Ability to gain and share knowledge regarding changing therapeutic areas. Extensive and varied clinical and laboratory research experience. Experiencing working with advanced research groups and product management on incorporating new technologies into product pipeline.
• Communicates clearly and effectively both orally and in writing with persons having diverse backgrounds of knowledge and experience; conduct meetings and make professional presentations; teach complex concepts and explain clinical material to non-clinical users

Desired Qualifications:

• Extensive knowledge of US FDA CFR and guidelines applicable to conducting clinical trials (i.e., GCP certification or similar). Strong knowledge of protocol and device development processes, clinical study design, study planning and management, and data monitoring.
• Extensive knowledge of EU MDR submission and document preparation, including the technical file, dossier for CE marking and other requirements.
• Project management and budgeting skills enabling efficient planning and execution of program milestones.
• Successful track record of hiring, developing, and managing high quality team members.
• Team player who can use positive methods to motivate his/her team and build good working relationships with cross-functional teams.
• Good organizational skills and ability to meet tight deadlines in an environment of competing priorities. Ability to routinely work on multiple tasks with multiple people while effectively prioritizing.
• Excellent interpersonal skills including problem recognition and solution definition with strong attention to detail, accuracy, and organization.
• Ability to create, implement and evaluate operational and administrative processes.
• Consulting and/or multi-disciplinary experience preferred.
• Ability to travel up to 30% (US)

The Annual Salary range for this position is: $185,000-240,000 plus bonus and stock.

We feel passionately about pay equality.  Discretionary adjustments to the position’s starting compensation may be made in consideration of other relevant factors pertaining to eligible applicants, including, but not limited to, their specific skills, level, geographical location, and comparison to other employees already in the same or similar roles.

*This range represents our good-faith and reasonable estimate regarding what we reasonably expect to pay for this position at the time of posting. 

Outset also offers the following benefits:

• Medical 
• Dental
• Vision
• EAP/Mental Health
• Life Insurance/AD&D
• Short/Long Term Disability
• FSA (Dependent & Healthcare)
• HSA w/ Employer contribution
• Commuter Benefits
• 401K w/ company match
• ESPP
• Fertility benefits
• Wellness initiatives
• Legal Assistance
• Pet insurance
• Financial Advisement & Wellbeing
• Tuition Reimbursement
• Student Loan Payback
• Employee discounts
• Professional Development/Learning
• Collaboration Days (lunch onsite)
• Happy Hours/Karaoke
• PTO/Sick time
• Holidays + Volunteer Day