Associate Director, Clinical Operations

Role Overview

• Responsible for execution and delivery of sponsored human subject research across all therapy areas and development phases in the UK to quality, time, budget, and resources as defined in the trial protocol as well as in local regulations, ICH GCP and BioNTech written standards
• Responsible for providing clinical monitoring oversight for studies executed by our strategic partners in the UK
• Actively engage with local partners and regulatory stakeholders to maintain and influence a positive operational environment for clinical trials in the UK
• Driving business efficiencies, implementation of new processes and quality improvement, facilitates sharing of best practices, learnings, and expertise at a local, regional, or global level where appropriate
• Ensuring the quality and integrity of clinical trials and actively identifies and manages any internal and external risks to the business
• Promoting the profile and credibility of the department with internal groups as well as external groups (hospitals, trial site networks, physicians, HCPs, the NHSE Cancer Vaccines Launch Pad, industry initiative groups etc.)
• Ensuring strategic local input is provided at early stages of clinical development planning to optimize in-country trial feasibility
• Building a strong collaboration with CRO teams to optimize delivery of clinical trials in the UK
• Collaborate closely with BioNTech’s Global Health Strategy team, the global and local Clinical Trial Teams and support opportunities to build strategic relationships with trial sites in the UK
• Contributing to the development and review of portfolio documents including: Trial Oversight Plans, Integrated Development Risk Management Plan Trial RACI matrix, Participant Recruitment and Retention Plans and SOPs.
• Supervision of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training
• Point of escalation in case of challenges in project activities with other BioNTech departments or external vendors.
• Translates the organization vision, mission and strategy into coherent plans / requirements that can be understood and implemented by clinical research staff. This includes ensuring that all teams understand and operate according to the agreed business priorities, regulatory requirements, and internal processes to ensure excellence in the delivery of studies and projects
• Responsible for identifying local vendors to support local and global trial execution
• Contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors
• Overseeing local project/program timelines and deliverables and identification of future requirements for the successful execution of a program
• Cultivating strong relationships with sites, government agencies, patient advocacy groups and local vendors including but not limited to CROs
• Overseeing the training status of the local project team and reporting training requirements to the Director Clinical Operations
• Supporting the QA team during internal audits, vendor audits and/or hosting inspections in the UK
• Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions

Requirements

• Degree in life sciences, public health, or related field (PhD, PharmD, or MSc preferred).
• Minimum 8 years of experience in pharmaceutical/biotech or related industry
• Profound knowledge and experience working with relevant legislation and international guidelines (ICH-GCP) for the performance of clinical research projects.
• Directly involved in addressing regulatory inspections or internal process audits.
• Involved in drafting/reviewing responses to health Authority and ethics committee questions
• Operational excellence in delivering clinical trials.
• Successful track record in, developing innovative solutions to accelerate trial start up and participant recruitment
• Proven ability to navigate a matrix environment and partner effectively with internal stakeholders, CROs and trial sites,
• A strong background of successful interactions with ethics committees, NHS R&D departments and the MHRA
• Experienced in negotiating contracts with trial sites
• High proficiency in oncology clinical trials involving complex design features (e.g. multiple arms, adaptive designs, treatment combinations)
• Results-oriented mind-set, and ability to manage competing priorities to meet or exceed targets at a country level.
• Excellent organizational, analytical and critical thinking skills
• Excellent written and verbal skills required
• Proficiency in using Microsoft® software (Word, Excel, Power Point, MS Project)
• Must be a demonstrated self-starter and team player with strong interpersonal skills.

Tech Stack

• Google Cloud Platform

Benefits

• BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.