Regulatory CMC Contractors for Small Biotech Company
Client background
This small, established biotech company is focused on novel biological and drug delivery technologies. They have over 100 employees and multiple approved products.
Challenge
Due to some recent turnover on their team, the Head of Regulatory Affairs was seeking a Regulatory CMC contractor to support all Regulatory CMC activities for several months. This includes writing DMF and CMC sections for INDs, along with change controls and life cycle management.
Approach
Dennis Partners identified 40 Regulatory CMC contractors at the Manager level. Within three days of starting the search, Dennis Partners produced four strong candidates who fit the designated criteria for the contract position.
Result
The client interviewed candidates by phone and video meetings. Within a week they decided to hire two of the contractors because they really liked both of them. Dennis Partners assisted in checking references and getting the contractors set up for weekly timesheets. Within two weeks from the start of the search, both contractors were able to start working remotely and have been able to make significant contributions to the client’s Regulatory team. The client was very happy that we were able to deliver two great contractors who met their needs in such a short amount of time!
Head of Regulatory Affairs for a Small Early Stage Rare Disease Company
Client background
This company is an innovator in RNAi for the treatment of various rare diseases. They went public in 2014 and have approximately 90 employees. In January 2019 the company began their Phase 1 clinical trial of their lead candidate for the treatment of Chronic Hepatitis B.
Challenge
The Chief Medical Officer needed to hire a Vice President of Regulatory Affairs to develop and lead all non-clinical, clinical and CMC regulatory strategies and activities for the company, including all regulatory submissions. This included collaboration with development partners, interactions with health authorities, and building out of the regulatory function.
Approach
Dennis Partners proposed a Retained Search to fill this crucial position. We kicked off the search in February with a pool of 218 candidates and were able to identify and engage multiple candidates who fit the client’s specifications. We screened, checked references, and presented the top five candidates within three weeks.
Result
The client interviewed candidates during the months of March and April and chose their top candidate by May. Dennis Partners assisted in brokering the offer and placing this candidate, who joined the firm in early June. Both the client and the new VP were thrilled with the outcome.
Regulatory Submissions Publishing Manager for a Mid-Sized Biopharma Company
Client background
This company is developing a strong pipeline of cell and gene therapies for the treatment of rare diseases. They plan to file their first BLA in 2019 and are on track to have 1,000 employees by the end of this year.
Challenge
This company had struggled to find good candidates for their Regulatory Submissions Publishing Manager position, which had been open for six months. They needed a skilled regulatory publishing professional who could lead eCTD publishing for their BLA and other applications.
Approach
Dennis Partners proposed an Exclusive Contingent Search help fill the role and kicked off the search in November 2018. We targeted 354 regulatory operations professionals in the Northeast further narrowed down to a pool of 89. From this we were able to attract, vet and submit five good candidates based upon the client’s specifications within six weeks of starting the search.
Result
The client interviewed candidates in December and January, and extended an offer to their top choice in February. We helped to negotiate the offer, including a relocation package. The candidate accepted the offer, moved his family, and started at the firm in April. Feedback from the client and the new-hire has been very positive so far.
Regulatory Affairs Director and Regulatory CMC Director for a Small Rare Disease Company
Client background
This company is a small, clinical stage rare disease company in the Greater Boston area. They have been in business since 2012 and have about 250 employees. They are developing a pipeline of treatments for rare neuromuscular diseases including Duchenne Muscular Dystrophy and Huntington’s Disease, and their lead candidate in in Phase 2a.
Challenge
Due to some recent departures, this client needed help in filling two crucial positions on their growing regulatory team. This included a Director of Regulatory Strategy and an Associate Director of Regulatory CMC to work on an upcoming NDA. Their internal recruiting team had failed to attract any suitable candidates.
Approach
Dennis Partners proposed dedicated Engaged Searches to fill both of these roles in a timely manner. Since this client did not have any relocation budget, we targeted regulatory professionals in the Greater Boston area who met the client’s specified criteria, a pool of 275 for the Director role and 363 for the CMC Director position. We kicked off both searches in December and we were able to identify, attract and present four candidates for each role within a month.
Result
After conducting three rounds of candidate interviews, the client decided to move forward with their top choices. Dennis Partners checked their professional references and negotiated the offers on the client’s behalf. We were able to fill both roles by March, with the new hires starting in April.
Vice President of Regulatory Operations for a Mid-Sized Biopharma Company
Client background
This company is developing a strong pipeline of cell and gene therapies for the treatment of rare diseases. They plan to file their first BLA in 2019 and are on track to have 1,000 employees by the end of this year.
Challenge
Based upon their ongoing growth and anticipated approval of their lead candidate, the company created a new position for a Vice President of Regulatory Operations. They needed a strong leader who could establish a long-term team strategy and build a high-performing global regulatory operations team. Their internal recruiting team was not able to identify any suitable candidates on their own.
Approach
Dennis Partners proposed an Engaged Search help fill the role and kicked off the search in March 2019. We targeted regulatory operations professionals at the Sr. Director, Executive Director and VP level. We identified 166 candidates from which we were able to attract, vet and submit six strong candidates based upon the client’s specifications within four weeks of starting the search.
Result
The client interviewed all six candidates which were submitted by Dennis Partners and extended an offer to their top choice by May. Dennis Partners helped to check the references, negotiate the offer package, and assist with relocation details. The candidate has just accepted the offer and will be starting in the new role as soon as the relocation is completed.
Regulatory Affairs Manager for an Early Stage Gene Therapy Company
Client background
This Boston area company is developing gene therapy treatments for rare neurological diseases including Parkinson’s Disease and ALS. They have been in business since 2013 and have approximately 140 employees. Their lead candidate is just entering Phase 2.
Challenge
Due to a recent departure, the client was seeking a Regulatory Affairs Manager to lead preparation and review of original INDs and to work directly with the FDA. They wanted to find a local candidate who could hit the ground running right away.
Approach
Dennis Partners proposed a Contingent Search and focused on local candidates at the Senior Associate level in the Greater Boston area. Our pool consisted of 499 candidates in the New England/Tri-State region, narrowed to 246, further narrowed to 112 with exact skillset match. We kicked off the search in late April and were able to present three strong candidates within three weeks.
Result
The client interviewed all three candidates in May and extended an offer to their top choice in early June. Dennis Partners helped to check the references and negotiate the offer package. The candidate has accepted the offer and will be joining the client’s team in a few weeks.