Position Title: Vice President/Sr. Director, Clinical Research
Reports to Position: CEO (in the interim)
Location: Hybrid/Cambridge, MA
Who we are:
Intergalactic Therapeutics is a bio-innovation company focused on overcoming the limitations of viral-based gene therapy and developing a best-in-class non-viral alternative. Intergalactic uses synthetic biology and engineered gene circuits to make covalently closed and circular DNA (“C3DNA”) molecules designed to provide a potentially safer and more effective solution for patients.
The Vice-President/Senior Director, Clinical Research is responsible for the strategy, planning, design, interpretation, and dissemination of clinical studies for all phases of clinical development. This position will work collaboratively with internal and external stakeholders to ensure activities are executed at high quality and in accordance with established timelines and budget in line with the department and corporate goals and within regulatory guidelines. This role will be a key member of the Leadership Team.
Who you are:
You are an experienced Clinical Research leader who leverages interpersonal relationships with internal and external stakeholders. You have a proven track record of leading and executing clinical studies in the biotech and/or pharmaceutical industry. You are resourceful and excited to contribute strategically and tactically as part of a dynamic start-up. You value collaboration, curiosity, commitment, and courageousness.
- Lead the development of clinical trial protocols, investigator brochures, and other documents required to conduct clinical trials
- Provide medical advice on the design of the clinical development program, strategic and tactical plans for investigational products in all phases of development
- Conduct investigator meetings and host wet lab, visit study sites to observe the procedures and discuss clinical study protocol with investigators, develop effective working relationship with patient advocacy groups, investigators, and key opinion leaders
- Develop and maintain cross-functional relationships with multiple functions including Research and Development, Engineering, Quality, Regulatory, Data Sciences, Statistics and Safety
- Commit to high standards always with respect to data integrity, patient-centricity, and global competitive development
- Collaborate with Clinical Operations in CRO selection, investigator selection, analysis of patient recruitment strategies, milestones, data collection and analysis, and ensure all clinical study activities are completed in accordance with applicable regulations and guidance, ICH GCP, and SOPs
- Oversee safety, including the review of SAEs and safety data in collaboration with Medical Monitor; ensure that sites and regulatory agencies are notified, and regulatory procedures are compliant
- Review clinical data from all phases of development and support study reports writing and publications
- Support clinical sections of INDs, NDA’s and other regulatory submissions
- Advanced Scientific degree required (MD, OD, PharmD, PhD)
- Minimum 10 years of experience in the biotechnology / pharmaceutical industry with at least 3 years of hands-on clinical development experience
- Experience in ophthalmology drug development/medical affairs highly preferred
- Experience with gene therapy highly preferred
- Working knowledge of FDA and other regulatory requirements, ICH guidelines, as well as understanding of all phases of drug clinical development
- Working knowledge of clinical medicine and clinical pharmacology and associated disciplines (e.g., biostatistics, data management, medical writing)
- Strong interpersonal skills and excellent verbal and written communication skills
- Demonstrated project planning, leadership, and negotiation skills as well as an ability to contribute creative yet practical solutions to problems
- Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion
- Ability to forge cross-functional working relationships with internal teams and external project partners
- Self-direction and self-motivated
- Ability to travel up to 50%
We believe diverse backgrounds lead to innovative thinking that enables effective treatment for millions of patients. Intergalactic is committed to making our organization an inclusive place for all individuals regardless of race, religion, national origin, age, sex and gender identity, sexual orientation, pregnancy status, familial status, disability status, veteran status, genetic information or any other protected class. We are also committed to providing reasonable accommodations to qualified individuals with disabilities. If you are selected to interview, to request an accommodation either as part of the interview process or during your potential employment with Intergalactic, please let your recruiter know and a member of our HR team will reach out to you.
If you feel energized by what you read here, but aren’t sure you meet every requirement, please consider applying! Above all, we’re looking for the right person with skills and talent to grow the company together all while enriching your professional and scientific experience.