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 is building 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.
- 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.