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For Companies At a Glance
- Tasks: Lead clinical strategy and oversee development programs in Ophthalmology.
- Company: Join a pioneering biopharma company focused on innovative treatments.
- Benefits: Enjoy remote work flexibility and competitive corporate perks.
- Why this job: Shape the future of clinical trials and make a real impact in healthcare.
- Qualifications: Advanced degree in medicine or pharmacy with 15 years of clinical development experience required.
- Other info: Ideal for those passionate about innovation in a fast-paced environment.
The predicted salary is between 72000 - 108000 £ per year.
About the Position
Location: Remote
Reporting to VP Clinical Development
We are seeking a Senior Director of Clinical Development to lead and drive clinical strategy, execution, and oversight of development programs. This leadership role is pivotal in shaping innovative clinical plans, managing development timelines and budgets, and collaborating with cross-functional teams, including Clinical Operations, CMC, Regulatory, Medical Affairs, Quality, Finance, and Legal. A key focus of this position is the design and execution of novel early development proof-of-concept (POC) trials, requiring strategic, outside-the-box thinking. This individual will play a critical role in clinical due diligence, guiding decision-making on development opportunities, and representing Clinical Development in internal and external stakeholder engagements.
Core Responsibilities
- Develop and implement clinical development strategies that align with broader corporate objectives.
- Drive the design of early and late-stage clinical trials, ensuring rapid and robust assessment of proof-of-concept and strategic progression.
- Serve as a disease area expert, collaborating with Key Opinion Leaders (KOLs) and external stakeholders to refine clinical approaches.
- Lead cross-functional teams to ensure study execution, adherence to milestones, and alignment with regulatory requirements.
- Provide clinical insights into Target Product Profiles (TPPs) and contribute to strategic evaluations.
- Author and oversee the creation of clinical trial documents, including study protocols, clinical study reports (CSRs), statistical analysis plans (SAPs), investigator brochures (IBs), and other key regulatory submissions.
- Train and support study investigators on protocol execution and trial procedures.
- Analyze clinical trial data to generate insights that inform strategic decision-making.
- Maintain oversight of clinical vendors, including defining scopes of work, budget negotiations, and performance management.
- Drive innovation by incorporating cutting-edge methodologies and technologies into trial design.
Qualifications & Expertise
- Advanced degree required (MD, MD/PhD, or PharmD) with a strong clinical background in Ophthalmology.
- At least 15 years of experience in pharmaceutical clinical development, with a minimum of 10 years in leadership roles managing clinical trial execution.
- Proven expertise in early-phase clinical development within Ophthalmology, with a track record of successfully designing and executing studies.
- Strong understanding of industry trends, treatment landscapes, and regulatory pathways, including IND and NDA processes.
- Ability to engage with external thought leaders, partners, and stakeholders to advance program objectives.
- Demonstrated leadership in cross-functional collaboration, problem-solving, and team management.
- Excellent communication skills with a strategic and solutions-oriented mindset.
- Deep knowledge of GCP, SOPs, and compliance regulations governing clinical trials.
- Experience working in dynamic, fast-paced environments, particularly within small or emerging biopharma organizations.
Senior Director Clinical Development - Ophthalmology employer: Barrington James Limited
Contact Detail:
Barrington James Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director Clinical Development - Ophthalmology
✨Tip Number 1
Network with professionals in the ophthalmology field. Attend industry conferences, webinars, and local meetups to connect with key opinion leaders and other experts. Building these relationships can provide valuable insights and potentially lead to referrals for the Senior Director position.
✨Tip Number 2
Stay updated on the latest trends and innovations in clinical development, particularly in ophthalmology. Subscribe to relevant journals and follow thought leaders on social media. This knowledge will not only enhance your discussions during interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Prepare to discuss your experience with early-phase clinical trials in detail. Be ready to share specific examples of how you've designed and executed studies, as well as how you've navigated regulatory pathways. This will showcase your expertise and align with the job's requirements.
✨Tip Number 4
Familiarise yourself with StudySmarter's mission and values. Understanding our culture and how we operate will help you tailor your conversations and show that you're a great fit for our team. This alignment can make a significant difference in the selection process.
We think you need these skills to ace Senior Director Clinical Development - Ophthalmology
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical development, particularly in Ophthalmology. Emphasise leadership roles and specific achievements in managing clinical trials.
Craft a Compelling Cover Letter: Write a cover letter that showcases your strategic thinking and innovative approaches to clinical trial design. Mention your experience with early-phase clinical development and how it aligns with the company's goals.
Highlight Cross-Functional Collaboration: In your application, provide examples of how you've successfully led cross-functional teams. Discuss your ability to work with various departments like Regulatory, Medical Affairs, and Quality to achieve project milestones.
Showcase Your Expertise: Demonstrate your deep knowledge of GCP, SOPs, and compliance regulations in your application. Include any relevant certifications or training that support your qualifications for this senior role.
How to prepare for a job interview at Barrington James Limited
✨Showcase Your Clinical Expertise
Make sure to highlight your extensive experience in clinical development, particularly in Ophthalmology. Be prepared to discuss specific trials you've led and the innovative strategies you implemented to overcome challenges.
✨Demonstrate Leadership Skills
This role requires strong leadership capabilities. Share examples of how you've successfully managed cross-functional teams and driven projects to completion, ensuring alignment with regulatory requirements and corporate objectives.
✨Engage with Strategic Thinking
Prepare to discuss your approach to designing early-phase clinical trials and how you incorporate cutting-edge methodologies. Show that you can think outside the box and adapt to the fast-paced nature of the biopharma industry.
✨Communicate Effectively
Excellent communication skills are crucial for this position. Practice articulating complex clinical concepts clearly and concisely, as well as your ability to engage with external stakeholders and thought leaders.
