Job description
About us:
Ascidian is redefining the treatment of disease by rewriting RNA via genetic medicine.
Ascidian Therapeutics was founded to rewrite RNA by editing and replacing human exons. We were inspired by ocean creatures, called Ascidians, who grow from larvae to adults by re-engineering their transcriptome through RNA editing via trans-splicing and alternative splicing. Transplicing also occurs in human cells, and Ascidian is the first company to leverage this biological process to develop therapeutics.
In our Allston/Boston labs, RNA biology meets today's cutting-edge genomics, computational biology, and deep-sequencing technologies to create a new class of medicines that address the underlying causes of genetic diseases, in particular diseases that are not amenable to current gene therapy or gene editing modalities.
We welcome you to come join our vibrant team and help us lead the way into a new era in genetic medicine.
Summary:
We are seeking a VP of Regulatory Affairs, reporting to our Chief Medical Officer, to play a lead role in building out our Regulatory organization. You will be responsible for all regulatory strategy and operations, and you will play a vital role in progressing our genetic therapies for rare diseases through IND filing and future development. We are looking for a collaborative leader to ensure successful completion of early phase and pivotal studies, compliance with regional and global regulations, and meeting timeline goals.
Responsibilities include:
- Take the lead on building Ascidian's regulatory strategy, processes and infrastructure to support program needs, in particular towards submission of INDs/CTAs for gene therapy programs in rare disease
- Collaborate with cross-functional project team members to design and implement high quality regulatory strategies and ensure timely submission of key regulatory documents
- Build the regulatory affairs function at Ascidian, provide mentorship and guidance to junior members of the team, and oversee and direct regulatory consultants to ensure tactical decision making and execution of priorities
- Participate in leadership team meetings to report on regulatory affairs activities and initiatives to progress corporate objectives; provide regulatory input and contribute to the development of portfolio strategy
- Monitor and analyze the global regulatory competitive landscape, applicable regulations, and guidelines to inform regulatory strategies across portfolio and drive proactive plans to ensure compliance
- Cultivate and maintain trusted relationships with regulatory authorities
- Provide timely review and approval of external facing materials to ensure regulatory compliance
- Develop and manage the regulatory affairs departmental budget
Skills, Qualifications and Experience:
- BA/BS degree in life sciences. Advanced degree in a scientific discipline (MS, PhD, PharmD) preferred
- 10+ years of experience in biopharmaceutical industry with broad experience in regulatory affairs and drug development
- Expertise and experience with gene therapies and rare diseases strongly preferred
- Experience with CMC, Clinical, Non-clinical and Regulatory submissions, particularly in the US and in Europe
- Demonstrated experience leading successful engagement with key regulatory agencies (e.g., FDA and EMA) throughout all stages of lifecycle
- Ability to interact effectively across all levels of the organizations; integrate functional expertise with business knowledge to solve problems; meet priorities and deadlines in alignment with corporate goals and objectives
- Ability to travel regularly to our Boston office (~10-20%)
- A "roll-up-the-sleeves" leader who understands the need for involvement within a growing company while also recognizing when to delegate and empower the team
Benefits:
We provide a vibrant startup environment where every employee contributes to our culture and science. We offer a generous total rewards plan that includes competitive compensation, stock options, and benefits. Our benefits include a top-tier health and wellness plan, commuter reimbursement or paid monthly parking, tuition or loan reimbursement, career development opportunities and so much more.
A final note - we highly encourage you to apply for our position, even if you are not sure you meet all the requirements. Everyone has unique talents, and at Ascidian, we look not only at your experience but your potential. We know that the best teams consist of diverse backgrounds, so please apply!
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