Vice President of Regulatory Affairs, Tempero Bio

Company Overview

Tempero Bio is a clinical-stage biopharmaceutical company developing treatments for substance use disorders and related conditions. Over 40 million people experienced a substance use disorder in the US in the past year, including 28.3 million with an Alcohol Use Disorder (AUD), and 1.3 million with a Cocaine Use Disorder (CUD). There are no medications approved by the FDA to treat Stimulant Use Disorders like Cocaine Use Disorder, and no new treatments have been approved by the FDA to treat Alcohol Use Disorder in the last 16 years.

With the development of our lead therapeutic candidate, TMP-301, a potent, orally-available, metabotropic glutamate receptor 5 (mGluR5) negative allosteric modulator (NAM), we’re committed to translating science into innovative medicines that will change the course of treatment in substance use disorders and in turn, revitalize millions of lives.

Tempero Bio is a portfolio company of Aditum Bio, a biotech venture capital firm co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research.

Position Summary

The Vice President (VP) of Regulatory Affairs is responsible for developing and delivering regulatory strategies to support the advancement of Tempero Bio’s pipeline. The VP will demonstrate hands-on leadership across all stages of development and will ensure all filings are efficient, thorough and complete. The VP, Regulatory Affairs will lead and guide Tempero Bio’s interaction with the FDA. The ideal candidate has a strategic mindset, is comfortable and capable of operating in a lean, fast-paced biotech environment.

Position Responsibilities 

• Regulatory Filings and Approvals: Complete regulatory documents (in-house and with vendors) and serve as the in-house regulatory expert to internal and external parties. Work with project teams and project manager to ensure this is delivered. 
• Regulatory Agency Interface: Serve as the interface between the regulatory agencies and our company, ensuring good and early communication. Ensure input from regulatory agencies is interpreted correctly by project teams, and action taken to prevent misunderstandings that could lead to delay of programs. Maintain up to date knowledge of regulatory affairs. 
• Strategic Guidance to Management: Ensure that the Management team understands feedback from regulatory agencies on clinical plans, clearly understanding associated risks with the programs. 
• Partner Collaborations: Manage the relationship with our external partners, ensuring that the interests of the Company are protected. 
• Vendor Oversight: This role may involve the oversight of external vendors, contractors and/or consultants.

Position Qualifications

• MS or PhD in Chemistry, pharmacology, or closely related field.
• Experience leading regulatory affairs at a growth-stage biotech
• Experience in relevant therapeutic areas, such as psychiatry or neurology.
• Strong track record in Regulatory Affairs and CMC Regulatory, including hands-on experience in Phase II clinical trials
• Excellent communication skills: including verbal, written, listening, and conveying messages to a broad range of audiences.
• Proven ability to work collaboratively internally and externally
• Results-oriented, accountable and able to work both independently and as a supervisor.

The range for this full-time position is $335,000 to $365,000 dependent on previous experience plus a target bonus, equity compensation and benefits including medical, dental, vision, disability, life and 401k plan with match.

Our time off benefits include flexible/non-accrued PTO plus 12 paid holidays. Sick leave will also be accrued at the rate of one hour for every thirty hours worked. For employees eligible to take parental leave, we may provide up to 8 weeks of paid additional leave.  Additional leave time may be available and may be paid from other sources.

Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience, relevant education and training, and other relevant factors. Please note the range reflects base salary and does not include target bonus, equity or benefits.