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- Tasks: Lead non-clinical strategy and oversee safety studies in a dynamic biotech environment.
- Company: Exciting young biotech firm focused on Neuroscience with a strong pipeline.
- Benefits: Flexible remote work, competitive salary, and attractive package for the right candidate.
- Other info: Opportunity to work in a lean, innovative company with excellent career growth.
- Why this job: Make a real impact in biotech by shaping non-clinical strategies and engaging with health authorities.
- Qualifications: PhD or MSc in Toxicology/Pharmacology with 10+ years of relevant experience.
The predicted salary is between 48000 - 72000 £ per year.
Head of Non-clinical
Our client, a young Biotech company with an exciting pipeline in Neuroscience, now have approval to hire a Head of Non-clinical. This hire will be accountable for developing overall Non-clinical strategy in line with Clinical Development Plan, to support the development of their pipeline up to NDA submissions.
The scope of this leadership role will include the design of the company’s nonclinical safety and toxicology studies in partnership with their external consultants; and implementation of planned studies with partner Non-clinical CRO’s and oversight of such, to all company requirements and regulatory requirements.
Most importantly, in this Non-clinical / toxicology leadership role, you will be the company’s point of contact and interface with health authorities; acting as the company Non-clinical / toxicology representative and addressing questions in interactions with FDA, EMA, etc., on nonclinical toxicology and safety topics, and solving or resolving such issues.
Toxicology expertise and experience with Inhalation routes of administration through INDs, NDAs, MAAs, etc. is highly desirable.
This is a full-time permanent role, with flexibility on salary / level depending on candidate with attractive package for the right candidate. This employee will have flexibility for some remote working from their home office in Ireland, the UK, or select European countries with occasional presence for meetings in HQ when required.
Requirements include:
- PhD, MSc or equivalent BSc degree in the areas Toxicology or Pharmacology, with 10+ years related experience.
- Experience in Neuroscience is preferred. Inhalation toxicology experience is required.
- Professional toxicological registration, ERT, UKRT or DABT is preferable.
- Experience of toxicological risk assessment of impurities, extractables and leachables is beneficial but not essential.
- Demonstrates a broad knowledge in field of pharmaceutical toxicology and possesses knowledge of the relevant regulatory guidelines and preparation of submission documentation.
- Experience with IND, NDA and MAA submissions is advantageous.
- Demonstrates good medical / scientific writing skills.
- Biotech experience and the attitude and ability to be effective in a lean company environment is an advantage.
- Proven ability to interact with and seek input from external partners/experts.
- Experience in working and influencing cross-functionally.
- Flexible, able to adjust, embrace and drive change.
For further details, please contact Larry on +353 1 – 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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Head of Non-clinical employer: The RFT Group
Contact Detail:
The RFT Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Non-clinical
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech and pharmaceutical sectors. Attend industry events or webinars where you can meet potential employers and showcase your expertise in non-clinical toxicology.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory guidelines and submission processes. Be ready to discuss your experience with INDs, NDAs, and MAAs, as well as how you've tackled challenges in previous roles.
✨Tip Number 3
Showcase your leadership skills! In your conversations, highlight instances where you've successfully led teams or projects, especially in a lean company environment. This will demonstrate your ability to thrive in a dynamic setting.
✨Tip Number 4
Don't forget to apply through our website! We make it easy for you to find roles that match your skills and aspirations. Plus, it shows you're serious about joining our team and contributing to exciting projects in neuroscience.
We think you need these skills to ace Head of Non-clinical
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in toxicology and non-clinical strategy. We want to see how your background aligns with the role, so don’t be shy about showcasing your relevant skills and achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this Head of Non-clinical role. We love seeing passion and enthusiasm, so let us know what excites you about the opportunity and how you can contribute to our mission.
Showcase Your Regulatory Knowledge: Since this role involves interfacing with health authorities, make sure to highlight your experience with regulatory guidelines and submissions like INDs and NDAs. We’re looking for someone who knows their stuff, so don’t hold back on your expertise!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
How to prepare for a job interview at The RFT Group
✨Know Your Stuff
Make sure you brush up on your toxicology and pharmacology knowledge, especially around inhalation routes. Be ready to discuss your experience with INDs, NDAs, and MAAs, as well as any relevant regulatory guidelines. This will show that you're not just familiar with the theory but can apply it in practice.
✨Showcase Your Leadership Skills
As a Head of Non-clinical, you'll need to demonstrate your ability to lead and influence cross-functional teams. Prepare examples of how you've successfully managed projects or teams in the past, particularly in a biotech setting. Highlight your experience working with external partners and health authorities.
✨Prepare for Regulatory Questions
Since you'll be the point of contact for health authorities, anticipate questions about your approach to nonclinical safety and toxicology studies. Think about how you would address potential issues with the FDA or EMA and be ready to discuss your strategies for compliance and risk assessment.
✨Be Ready to Adapt
Flexibility is key in a lean company environment. Prepare to discuss how you've embraced change in previous roles and how you can drive that change within the company. Show that you're not only adaptable but also proactive in seeking solutions to challenges.