Sourcing Report: https://docs.google.com/document/d/176owLpM0dNKDaaK_r43-3vRDAv0Tnin3JKmlHXRz1Wo/edit?usp=sharing
Client Name: Axsome Therapeutics
Location: New York City 10038 (will relocate), will work remote until COVID-19 eases
Role Title: Senior Manager of Regulatory Affairs OR Associate Director of Regulatory Affairs
Salary: $100 – $150k+ for Sr Mgr and $150-$225 for Associate Director (however, wide open for the right candidate), includes significant bonus and equity
A clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders.
- BA/BS in a scientific discipline
- 2-12 years of regulatory affairs experience
- Experience filing an NDA (New Drug Application) or IND (Investigational New Drug) application with FDA
- Advanced degree (MD, Ph.D., or PharmD)
- CNS experience
- Clinical development experience
- Rare opportunity to work for a publicly-traded company with only 50 employees valued at $3 Billion
- Entrepreneurial minded leadership and culture
- Be on the cutting edge of a rapidly growing CNS Biopharmaceutical company – incredible drug pipeline
- Join a small Regulatory Affairs team with a lot of room for advancement as they grow. Currently 50 employees, but plans for 250+
Ideal Candidate: Manshi Shah – Nearly 5 years in Reg Affairs, nice career trajectory from Reg Affairs to Manager of Reg Affairs, works at Allergan (competitor), this opportunity represents a nice promotion for Manshi
Karthik Pericherla – We connected with Karthik and he made it all the way to the offer stage, great candidate to base other searches off of
Search 1 – Regulatory Affairs, New York City, NDA, IND, degree
Search 2 – Regulatory Affairs Manager, New York City, (NDA OR IND OR FDA submission), degree
Keywords to use: NDA, IND, regulatory affairs, FDA submissions
Questions to Ask Yourself
- Does the candidate meet the Must-Haves criteria?
- Would the candidate be taking a demotion?
- Are there any pink/red flags?
- Job Hopping
- Gaps in Employment
- Currently a consultant
- Declining stage of career arc
- If so, seek to discover.
- Where are they on the career arc?
- Why do you like them as a candidate?
- Name, my team and I are conducting a preliminary search for a Reg Affairs leadership opportunity. This is a rare opportunity to join the small RA team of a growing Biotech (50 people). As they grow, as will their RA department. Would you be open to learning more about this?
- Hey Name! We are looking for a Reg Affairs leader to join a small RA team with a growing Biotech in NYC. Based on your background in blank, I believe you’d be a good fit for the position. Would you be open to learning more about this opportunity?
Our client is a growing Biotechnology company out of Manhattan. They develop novel drugs that treat a variety of central nervous systems diseases. Their recent drug pipeline success over the last year has caused them to expand, fast. That includes bringing on a Regulatory Affairs leader to join their small, but growing team. They have a bright future and aggressive plans to expand their teams. This is the perfect time to join them and would represent a great potential career move.