About TrialSpark

The biggest bottleneck in bringing new treatments to patients is clinical development. Getting a drug through the development process often takes a decade and may cost over a billion dollars. And the problem is only getting worse.

TrialSpark is a technology company that brings new medical treatments to patients faster. We’re reimagining the clinical trial by using technology to streamline every aspect of the trial. On top of that, to fulfill our mission, we’re acquiring our own drug assets and acting as a full stack drug development company to truly transform end-to-end clinical development. 

About the position

As the VP of Clinical Operations at TrialSpark, you’ll be responsible for leading and managing three key groups within TrialSpark: Clinical Project Management, Clinical Trial Management (Monitoring/Study Regulatory), and Data Management. You will work cross-functionally to build clinical operational strategies for the TrialSpark study portfolio, as well as promote innovation and process excellence within and across all ongoing and future studies.

Your day-to-day activities will include the implementation and execution of the overall clinical studies strategy, ensuring consistency, quality and compliance with global clinical standards and regulations. In addition to running the day-to-day, you will be charged with driving efficiency and speed in the clinical trial process.

TrialSpark is looking for a First Principles thinker who can develop and execute on an innovative clinical operations strategy.  We are only looking for candidates who can help us create a world where clinical trials are run differently; in line with our mission to bring new treatments to patients faster by reimagining the clinical trials process.

Key Responsibilities will include:


  • Provide strategic direction and leadership for collaboration of key TrialSpark teams, including Clinical Project Management, Clinical Trial Management, and Data Management to ensure cross-functional efficiency to support all TrialSpark clients.
  • Provide oversight over key GxP vendors throughout study execution 
  • Partner with BD and commercial teams upstream to ensure trial designs for upcoming studies are sound and are a good fit for TrialSpark’s operating model.
  • Collaborate with Medical, Technology, and Data to develop and execute on strategies for running clinical operations, creating efficiencies and delivering high quality clinical trials.
  • Assess and implement innovative clinical trial and data management approaches, focusing on quality and efficiency.
  • Represent, advocate, and promote TrialSpark’s approach externally to Sponsors, Partners, and Regulatory Authorities. 
  • Provide direction and mentorship to staff including setting goals that are aligned with both corporate and project goals.

Clinical Trial Oversight:

  • Oversee technical expertise for the development of clinical trial documentation and trial conduct, including oversight of Key Performance Indicators, Key Risk Indicators and budgetary indicators both within and across programs.
  • Oversee end-to-end tracking of clinical trial delivery and collaboration with other functions to identify and mitigate issues as they arise to ensure timely and on-budget trial execution.
  • Lead executive steering committee meetings with our Sponsors
  • Partner with QA to maintain inspection readiness across all programs.
  • Support development of clinical operational standards, such as SOPs, forms, templates and tools as necessary to ensure timely, efficient and high quality clinical trial deliverables.

Business Development:

  • Represent TrialSpark’s clinical operations team in sponsor-facing Bid Defense meetings.
  • Ensure the clinical operations resources assigned to a trial are the most appropriate for the sponsor’s requirements.
  • Find and offer solutions which employ TrialSpark’s unique strengths/competitive advantages.

About you

  • A demonstrated ability to plan and lead teams in executing complex global clinical programs and trials.
  • Deep experience with all aspects of trial management, including feasibility, study planning and budgeting, study resourcing, vendor management, risk management, stakeholder management, and more.
  • Thorough knowledge and understanding of drug development and clinical research concepts, practices, and regulations.
  • Critical thinker with the ability to step back and rethink legacy assumptions in the clinical research space; should be able to point to what’s wrong, and how you would do it differently if starting from scratch.
  • Embraces open conversations and challenges to status quo thinking.
  • Excellent cross-functional partnership skills; you know how to work across an organization to achieve objectives and meet timelines.
  • Solid written and oral communication skills; can synthesize complex concepts and deliver messages clearly.
  • Competency with data analysis and fluency with managing to metrics and key performance indicators.

Skills & Competency

  • Expertise in drug development, operations and strategic planning, as well as clinical operations and clinical project management.
  • Experienced in running clinical development projects under the Code of Federal Regulations (CFR), International Council for Harmonization Good Clinical Practices (ICH-GCP).
  • Ability to work on and solve complex problems.
  • Proven ability to build and develop high-powered teams while fostering productivity, cohesiveness and collaboration.
  • Excellent communication skills and experience in a dynamic and growing organization.


  • BS or BA required, preferably in life sciences or a related field; advanced degree preferred.
  • Minimum of 15 years experience in clinical development in the pharmaceutical and/or biotechnology industry, clinical research organizations, academic research organizations, or clinical research institutions.
  • Minimum of 10 years of clinical operations experience.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Apply for this Job

* Required

U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at TrialSpark are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.