At a Glance
- Tasks: Lead innovative medical studies and collaborate with cross-functional teams to generate impactful evidence.
- Company: Join a pioneering biotech company dedicated to improving patient outcomes.
- Benefits: Attractive salary, comprehensive health benefits, flexible working options, and opportunities for professional growth.
- Other info: Dynamic role with significant career advancement potential in a collaborative environment.
- Why this job: Make a real difference in healthcare by driving cutting-edge research and evidence generation.
- Qualifications: PharmD/PhD/MD with extensive experience in clinical development and medical affairs.
The predicted salary is between 60000 - 80000 £ per year.
Overview
The Medical Scientific Director is accountable for the day-to-day oversight of numerous Bio Marin-sponsored and collaborative studies across a therapeutic area, ensuring consistency of approach, conduct, monitoring, analysis, and reporting of studies within one or more programs.
The role partners with Real World Evidence (RWE)/Epidemiology, Global Medical Leads, Data Sciences and Global Study Operations to develop practical study strategies and provide hands-on study operations and execution support for Medical Affairs-led studies from cross-functional partners.
The Medical Scientific Director is part of the Integrated Evidence function comprising subject matter experts in evidence planning, observational study design and data interpretation.
The function drives excellence in evidence planning and implements novel study design approaches to generate robust evidence to enhance understanding of unmet medical need, support patient and endpoint selection for clinical studies, and inform medical practice on appropriate use and long-term safety and effectiveness of Bio Marin products to drive clinical adoption.
Responsibilities
- Execute evidence generation activities (non-interventional, low-interventional and interventional Phase IIIb/IV studies) that fill priority evidence gaps identified in product Integrated Evidence Plans (IEPs).
- Collaborate with Global and Country Medical Leads, RWE Lead, and HEOR to understand key global and local needs and opportunities and develop strategic study pull-through and dissemination plans.
- Work with operational strategic partners to ensure successful implementation of GMAF-led studies; identify issues, lead complex solutions, and escalate as appropriate.
- Provide scientific input into study concepts, protocols and protocol amendments, statistical analysis plans, data review plans, and responses to regulatory questions regarding scientific aspects of study protocols.
- Lead the development of annual, interim and periodic study reports for Medical Affairs-led studies, coordinating SME input, data interpretation and presentation, and addressing regulatory questions where relevant.
- Design secondary data analysis plans of Bio Marin clinical and real-world data to support program strategy.
- Ensure adequate medical monitoring oversight of assigned studies including monitoring and arbitration on subject eligibility, safety data quality, development and review of ICFs, CRFs, TLGs, accurate AE and concomitant medication coding, and inspection readiness activities.
- Presents results of assigned studies to internal and external stakeholders, including at scientific conferences and other relevant forums.
- Coordinate Medical Affairs input in preparation of regulatory submissions, responses to regulatory queries, IRB/Ethics Committee questions, and program regulatory inspections and audits for assigned programs.
- Participate in initiatives to enhance or drive efficiency in study implementation.
Qualifications
- Pharm D/Ph D/MD with at least 5 years of experience conducting observational and Phase IIIb/IV studies within Clinical Development and/or Medical Affairs; MS/MPH with 10+ years of similar experience.
- Experience delivering a portfolio of protocols and ensuring they meet strategic program objectives.
- Experience responding to regulatory agency, IRB/Ethics Committee questions regarding study designs and protocol conduct.
- Proven track record of working with cross-functional partners to ensure successful end-to-end delivery of studies in support of product Integrated Evidence Plans.
- Track record of delivering high-quality novel observational and Phase IIIb/IV studies.
- Ability to work effectively in a cross-functional matrix to shape study strategy for one or more assigned projects.
- Awareness of novel prospective observational and interventional study designs.
- Understanding of statistical and data analysis, research methods and design.
- Experience in study monitoring.
- Advanced knowledge of the clinical research process and Good Clinical / Pharmacoepidemiology Practice standards and requirements related to conducting research and disseminating scientific information.
- #J-18808-Ljbffr
StudySmarter Expert Advice🤫
We think this is how you could land Medical Scientific Director in City of Westminster
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We think you need these skills to ace Medical Scientific Director in City of Westminster
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at BIOMARIN!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show BIOMARIN that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at BIOMARIN!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At BIOMARIN, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at BIOMARIN
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at BIOMARIN that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with BIOMARIN’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
