At a Glance
- Tasks: Lead a team in managing global clinical trials and develop operational strategies.
- Company: Dynamic biotech firm focused on innovative clinical research.
- Benefits: Hybrid work options, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on individual development and team success.
- Why this job: Make a real impact in clinical operations and shape the future of healthcare.
- Qualifications: 8+ years in clinical research with leadership experience and strong project management skills.
The predicted salary is between 75600 - 92400 £ per year.
The Associate Director Study Management (AD Clinical Operations) is responsible for leading a team of Global Trial Leaders and Trial Managers within the Study Management Organization.
The position is responsible for staff development and study oversight, and will work closely with the Director for input on project assignments, workload distribution, resourcing, and prioritization.
The Associate Director directly influences trial objectives and ensures common operational issues/challenges are identified within and potentially across trials and programs and are addressed through operational risk mitigation, including proposals for alternative solutions.
The Associate Director is accountable for the operational execution and delivery of assigned trials within a program, ensuring alignment across study teams and functions.
This is a hybrid role based in Maidenhead. However, for exceptional candidates, remote working arrangements may also be considered.
- Summary Of Key Responsibilities
- Develop and execute trial operational strategies for assigned studies and contribute to broader program-level planning in partnership with the Director and cross-functional stakeholders.
- Lead operational scenario planning and mitigate trial level risks that may impact timelines / budget.
- Ensure appropriate timely and quality oversight, and appropriately elevate issues to the Director, Quality and functional leadership.
- Ability to effectively communicate the operational strategy, and defend the operational plan and costs associated to CTWG, CDST, Director, leadership and at governance meetings as appropriate.
- Lead and ensure inspection readiness for the trial/s
- Build knowledgeable and skilled team with competencies and capabilities to successfully set up and deliver clinical trials
- Promote strong collaboration across cross-functional teams
- Setting goals in alignment with company, program, and departmental goals
- Ensure staff training on procedures and systems associated with their roles
- Develop a team that consistently achieves strong results through nurturing individual growth, effectively managing performance, and providing guidance
- For early development programs, AD may represent Clinical Operations at CDST
- Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.
- Lead or participate in process improvement activities at a trial and department level as needed
- Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits
- Ability to travel (expected annual average of 10% but flexibility to go over or below this as required).
Qualifications
- BS/ BA degree is required.
- Minimum 8+ years of clinical research experience gained with a CRO, Biotech or Pharmaceutical Company working on Phase 1-4 global clinical trials, at least 3 of which leading end to end global clinical trials with experience in conducting Phase 3 registrational trials.
- Minimum 2-5 years of direct people leadership experience, including coaching, performance management, and development of clinical operations professionals.
- Experience in and knowledge of the pharmaceutical development process
- Excellent decision-making, analytical and strong financial management skills are essential to this position
- Ability to manage all aspects of execution of a clinical trial
- Must possess excellent leadership skills, proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision
- Experience in leading without authority and in multifunctional matrixed and global environments
- Strong project planning/ management, communication (written and verbal) and presentation skills
- Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.
- Apply project management best practices to programs. Experience in novel clinical drug development.
- Proficient with MS Office Suite (Excel, Word and Power Point) and MS Project.
- #J-18808-Ljbffr
Associate Director Study Management in Maidenhead employer: Alnylam Pharmaceuticals
As an Associate Director in Brand Marketing for Rare Diseases, you will join a dynamic and innovative team dedicated to improving patients' lives through strategic marketing initiatives. Our company fosters a collaborative work culture that values employee growth, offering opportunities for professional development and the chance to make a meaningful impact in the rare disease space. Located in a vibrant international setting, we provide a supportive environment where your contributions are recognised and rewarded, making us an excellent employer for those seeking a fulfilling career in the pharmaceutical industry.
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We think this is how you could land Associate Director Study Management in Maidenhead
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We think you need these skills to ace Associate Director Study Management in Maidenhead
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 Alnylam Pharmaceuticals!
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 Alnylam Pharmaceuticals 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 Alnylam Pharmaceuticals!
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 Alnylam Pharmaceuticals, 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 Alnylam Pharmaceuticals
✨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 Alnylam Pharmaceuticals 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.
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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.
