About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark has built a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.

TrialSpark recently raised their Series C, and is putting the capital to work by  in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.



We are looking for the first Vice President of Regulatory Affairs who will be responsible for the development and execution of the company regulatory strategy. This position will be responsible for developing global regulatory plans that aim to speed up development while adhering to the regulations.  A strong desire to be creative in the approach to development of new medicines will be an essential key success factor for this position so experience with all of the regulatory procedures to speed up approvals will be important.  The successful candidate will have a strong track record in the submission and approval of new medicines across the spectrum of drug types and dosage forms, strong relationships with the FDA and other global health authorities is essential. A proven track record of building and leading world class regulatory teams is essential. 

The VP, Regulatory Affairs will report to the Chief Medical Officer and work cross functionally with the Medical, QA, Clinical Trial team and Business Development Team.



  • Development of winning global regulatory strategy for approval and commercialization for all of the TrialSpark products
  • Lead the development of competitive and creative regulatory plans that expedite development, maximize the probability of success, and mitigate risks. This is particularly important when reviewing prospective products to license.
  • Utilize experience across a wide range of therapeutic, drug classes and dosage forms, and strong relationships with FDA and other global regulatory authorities to guide project teams through submission to approval of all products.
  • Responsible for oversight of original applications and product maintenance, such as information amendments and annual reports as needed.  Experience with development and submissions of INDs, CTAs, BLAs, and MAAs, and related filings to regulatory agencies within established timeframes is essential. 
  • Build out the regulatory teams as the company grows through a mix of full-time and vendor/contracted resources.
  • Oversee team preparation for, and conduct of, health authority meetings.
  • Serve as the regulatory lead for selected programs, especially during early stages of company growth.
  • Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval.  


About you

  • You have an advanced degree in a scientific discipline (MS, PhD, PharmD) preferred, with at least 10 years of relevant regulatory experience. 
  • You have a proven history of strong leadership and management of a world class regulatory team covering all aspects of Regulatory Affairs, eg CMC, Regulatory Operations, strategic clinical development and preferably medical writing.
  • You will show a willingness to provide leadership and role modeling for the members of the team and other parts of the organization.
  • You will have the ability to show a focus on first principles and to challenge the status quo.
  • You will be comfortable with “hands-on” and  “roll-up-the-sleeves” when necessary
  • You will be a leader that understands the need for involvement in all aspects of development within a small company environment while recognizing when to delegate and seek results from the team.
  • You will be comfortable working with the senior leadership team and provide clear input to the regulatory needs and strategy as the company evolves.  
  • You are willing to work with a sense of urgency to get things done in a timely manner
  • You are relentlessly focused on helping patients with everything that you do to move the products onto the market
  • Though not required, experience in both biotech and large pharma is preferred.


We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.

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

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. 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.

As set forth in TrialSpark’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

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 the 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.