At a Glance
- Tasks: Lead clinical trials for autoimmune/rare diseases and ensure participant safety.
- Company: Vertex, a global biotech company focused on scientific innovation.
- Benefits: Hybrid work options, competitive salary, and commitment to diversity.
- Other info: Collaborative environment with opportunities for international travel.
- Why this job: Make a real difference in patients' lives through innovative clinical research.
- Qualifications: MD or equivalent with clinical development experience in autoimmune/rare diseases.
The predicted salary is between 51750 - 63250 £ per year.
The Clinical Development Medical Director, Autoimmune/Rare Diseases will serve as the Medical Lead for Vertex clinical trials, working with cross-functional multidisciplinary study teams on clinical trial strategy, design and execution and serving as the Medical Monitor responsible for monitoring the safety of enrolled subjects on assigned trials. The incumbent will work on multiple trials in all Phases of clinical development, and may also participate in other selected projects in clinical development.
Key Duties and Responsibilities
- Leads the development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance.
- Serves on cross-functional Study Execution Teams (SET) for assigned trials, working with other team members to achieve efficient, high-quality study execution.
- Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical sections of INDs and CTAs, safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate.
- Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms (ICF), clinical research forms (CRF), statistical analysis plans (SAP), clinical pharmacology analysis plans (CPAP), and clinical study reports (CSR).
- Acts as liaison between Translational Medicine/Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Operations) for assigned studies.
- Represents Vertex to outside medical personnel in the development of clinical protocols and study conduct.
- Performs other duties as assigned related to clinical programs.
Knowledge and Skills
- Excellent oral and written communication skills.
- Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate.
- Effective at building alliances across functions, based on end-to-end drug development thinking and experience.
- Experience developing and validating clinical endpoints and biomarkers in complex, heterogeneous disease populations.
- Clinical Development experience in autoimmune/rare diseases, ideally in neurology, rheumatology, or hematology.
Education and Experience
- MD, DO or equivalent ex-US medical degree.
- Clinical Development experience in autoimmune/rare diseases, ideally in neurology, rheumatology, or hematology.
- Extensive clinical research experience in an academic or industrial setting, or the equivalent combination of education and experience.
- Typically requires experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design.
- Typically requires experience with design, execution, and analysis of clinical trials required.
- International travel to be expected at 20%.
Flex Designation
Hybrid-Eligible Or On-Site Eligible. Flex Eligibility Status: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
Clinical Development Medical Director, Autoimmune/Rare Diseases in City of Westminster employer: Vertex Pharmaceuticals
Vertex Pharmaceuticals is an exceptional employer that prioritises employee well-being and professional growth. With a flexible hybrid working model, our team enjoys a supportive work culture that fosters collaboration and innovation, while also providing ample opportunities for career advancement in the dynamic field of tax compliance.
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We think you need these skills to ace Clinical Development Medical Director, Autoimmune/Rare Diseases in City of Westminster
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for the Clinical Development Medical Director, Autoimmune/Rare Diseases at Vertex Pharmaceuticals, focus on highlighting your clinical experience and any specific training you've undergone. Include any relevant placements or internships you’ve completed, as well as any certifications that bolster your qualifications in human medicine.
Highlight Your Soft Skills:In the field of human medicine, soft skills are just as crucial as technical knowledge. Mention your communication skills, empathy, and teamwork experiences in your CV and cover letter. This shows that you can work well in a clinical setting and with patients, which is super important in this industry!
Tailor Your Cover Letter Thoughtfully:Be sure to personalise your cover letter for the Clinical Development Medical Director, Autoimmune/Rare Diseases at Vertex Pharmaceuticals. Mention why you’re passionate about human medicine and how you align with the company’s mission. This is your chance to convey your enthusiasm and make a case for why you'll be a valuable addition to the team!
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How to prepare for a job interview at Vertex Pharmaceuticals
✨Brush Up on Clinical Knowledge
Since you're aiming for a role in human medicine, make sure you’re sharp on the latest clinical guidelines and practices relevant to the position. Be prepared to discuss case studies or scenarios you might encounter in the role. This will show that you're not just knowledgeable but also ready to apply that knowledge in real-life situations.
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Ethics are a big deal in human medicine, so expect questions that assess your decision-making in tricky situations. Think about how you'd handle ethical dilemmas or patient confidentiality concerns. Prepare a few examples that illustrate your thought process and how you prioritise patient welfare in your decision-making.
