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Clinical Trial Regulatory Lead

2 months ago

Slough Berkshire, United Kingdom EPM Scientific Full time

ABOUT THE COMPANY We are a pioneering pharmaceutical company dedicated to the discovery, development, and delivery of innovative treatments for patients with rare and life-threatening diseases. Our mission is to transform the lives of those affected by these challenging conditions through cutting-edge research and patient-centric drug development. Located just outside London, we are strategically positioned to leverage the region's rich talent pool and robust life sciences ecosystem.

In this role, you will be responsible for overseeing the strategic planning, execution, and management of clinical development programs from early-stage development through to regulatory submission and post-marketing support. You will play a critical role in driving the success of our clinical programs, ensuring they are delivered on time, within budget, and in compliance with all regulatory requirements.

Collaborate with cross-functional teams, including research, regulatory affairs, commercial, and medical affairs, to design and execute comprehensive clinical development plans.
Provide leadership and direction to clinical study teams, ensuring the successful execution of clinical trials across multiple phases of development.

Oversee the day-to-day management of clinical programs, including study design, protocol development, site selection, patient recruitment, data collection, and analysis.
Monitor program progress against milestones, budgets, and timelines, proactively identifying risks and implementing mitigation strategies as needed.
Ensure all clinical activities are conducted in compliance with Good Clinical Practice (GCP) guidelines, ethical standards, and applicable regulatory requirements.

Regulatory and Compliance:
Serve as the primary point of contact for regulatory agencies, overseeing the preparation and submission of regulatory documents, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and New Drug Applications (NDAs).
Lead regulatory interactions, including meetings with health authorities, to facilitate the approval and commercialization of new therapies.

Data Analysis and Interpretation:
Collaborate with biostatistics, data management, and clinical operations teams to ensure the accurate and timely analysis of clinical trial data.
Interpret study results and prepare clinical study reports, publications, and presentations for internal and external stakeholders.

Manage program budgets, ensuring the efficient allocation of resources and adherence to financial constraints.
Oversee the selection and management of Contract Research Organizations (CROs) and other external vendors, ensuring high-quality deliverables.

Provide mentorship and leadership to junior clinical staff, fostering a culture of continuous learning and professional growth.
Lead by example, promoting a patient-centric approach to drug development and a commitment to scientific excellence.

A Master’s or Doctoral degree (MD, PhD, or PharmD) in a relevant scientific discipline such as Clinical Research, Medicine, or Pharmacology.

A minimum of 8 years of experience in clinical development, with at least 3 years in a leadership role within the pharmaceutical or biotech industry.
In-depth knowledge of clinical trial design, execution, and regulatory requirements.
Strong understanding of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and other relevant regulatory standards.
Excellent communication and presentation skills, with the ability to articulate complex clinical and scientific concepts to diverse audiences.
Strong analytical skills, with the ability to interpret clinical data and make informed decisions.
Proactive problem solver, with a track record of successfully managing program risks and challenges.
Organizational and Project Management Skills:
Highly organized, with strong project management skills and the ability to manage multiple complex projects simultaneously.
Ability to work effectively in a fast-paced, dynamic environment with a focus on delivering high-quality results.

Join a company at the forefront of rare disease research, where your work will directly contribute to improving the lives of patients with unmet medical needs.

Professional Growth:
~ Opportunities for career advancement and professional development in a fast-growing, innovative company.

Competitive Compensation:
~ A competitive salary and benefits package, reflective of your experience and contributions.