At a Glance
- Tasks: Lead innovative clinical programs in biotech, ensuring patient safety and scientific integrity.
- Company: Join a cutting-edge biotech firm making waves in cell and gene therapy.
- Benefits: Competitive salary, dynamic work environment, and opportunities for professional growth.
- Other info: Engage with global regulatory bodies and drive successful clinical trial outcomes.
- Why this job: Make a real impact in drug development and collaborate with top industry experts.
- Qualifications: MD or equivalent with 10 years in pharma/biotech and strong leadership skills.
The predicted salary is between 100000 - 150000 € per year.
ARTO is again working with an innovative biotech company who are looking to progress their lead program through the clinic. With already strong data, they are looking for an experienced Clinical Development Physician to drive this program.
About the job:
- Provide strategic and operational medical leadership for Phase I and II clinical programs across cell and gene therapy/immunology portfolios, ensuring scientific integrity and patient safety throughout development.
- Lead end-to-end clinical development activities including protocol design, study execution, data interpretation, regulatory interactions, and clinical study reporting.
- Serve as the medical lead for early-stage clinical trials, overseeing dose escalation strategies, safety review committees, and benefit-risk assessments.
- Collaborate cross-functionally with Clinical Operations, Translational Sciences, Regulatory Affairs, Biometrics, and CMC teams to drive program milestones and development plans.
- Contribute to clinical development strategy, target product profiles, and lifecycle planning aligned with corporate and portfolio objectives.
- Build and maintain strong relationships with investigators, key opinion leaders, academic collaborators, and external partners within the biotechnology ecosystem.
- Support global regulatory submissions and interactions with agencies including the FDA, EMA, and MHRA, ensuring compliance with GCP and applicable regulatory standards.
Qualifications:
- MD or equivalent medical degree, PharmD, or PhD in a clinical and/or scientific discipline.
- Clinical background or sufficient industry experience within Rheumatology/Immunology.
- A proven leader with roughly 10 years pharmaceutical/biotechnology industry experience in all phases of drug development.
- Deep knowledge of the drug development process with a focus on clinical study design and management; ability to collaborate with, support, and oversee CROs.
- Able to drive strategic thinking and plans for successful clinical trial outcomes.
- Experience interfacing with the global regulatory authorities (incl. FDA, EMA) and respective standards, including hands-on experience in global drug development.
- Recent experience of IND and NDA/BLA submissions strongly preferred.
- Dynamic individual with excellent written, communication, and interpersonal skills.
If you'd like to talk through this further, please reach out via the below email address jamie.stephens@arto-talent.com
Senior/Execuitve Medical Director - Clinical Development employer: ARTO
Join an innovative biotech company that prioritises scientific integrity and patient safety while fostering a collaborative work culture. With a strong focus on employee growth, this organisation offers unique opportunities to lead cutting-edge clinical development in cell and gene therapy/immunology, all within a supportive environment that values strategic thinking and cross-functional collaboration. Located in a vibrant area, employees benefit from a dynamic atmosphere that encourages professional development and meaningful contributions to the biotechnology ecosystem.
StudySmarter Expert Advice🤫
We think this is how you could land Senior/Execuitve Medical Director - Clinical Development
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech field, especially those who have experience in clinical development. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of the latest trends in cell and gene therapy. We want you to showcase your expertise and passion for the industry, so be ready to discuss how you can contribute to their innovative projects.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation. It keeps you fresh in their minds and shows your enthusiasm for the role.
✨Tip Number 4
Apply directly through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team and making an impact in clinical development.
We think you need these skills to ace Senior/Execuitve Medical Director - Clinical Development
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in clinical development, especially in cell and gene therapy or immunology. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects and achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your skills can drive the programme forward. We love seeing genuine enthusiasm, so let your personality come through!
Showcase Your Leadership Skills:As a Senior/Executive Medical Director, leadership is key. In your application, highlight specific examples of how you've led teams or projects in the past. We want to know how you’ve driven successful outcomes and built strong relationships in the biotech space.
Apply Through Our Website:We encourage you to apply directly through our website for a smoother process. It helps us keep track of applications and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at ARTO
✨Know Your Stuff
Make sure you’re well-versed in the latest developments in cell and gene therapy and immunology. Brush up on your knowledge of clinical trial phases, especially Phase I and II, and be ready to discuss how your experience aligns with the company’s goals.
✨Showcase Your Leadership Skills
As a Senior/Executive Medical Director, you’ll need to demonstrate your leadership capabilities. Prepare examples of how you've successfully led clinical development teams, managed cross-functional collaborations, and driven strategic initiatives in previous roles.
✨Understand Regulatory Requirements
Familiarise yourself with the regulatory landscape, particularly regarding FDA, EMA, and MHRA submissions. Be prepared to discuss your hands-on experience with IND and NDA/BLA submissions, as well as how you ensure compliance with GCP standards.
✨Build Relationships
Highlight your ability to build and maintain strong relationships with key opinion leaders and external partners. Think of specific instances where you’ve collaborated effectively with investigators or academic collaborators, and be ready to share those stories.