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Director - clinical trials (m/f/d)

Mainz
BioNTech SE
Director
Inserat online seit: 5 Dezember
Beschreibung

Director Site Contracts & Budgets (remote) Cambridge, US; Gaithersburg, US; London, United Kingdom; Mainz, Germany; New Jersey, US | full time | Job ID:9980 The Director, Clinical Trial Contracts and Budgets, is responsible for building and leading a high-performing team that manages the full lifecycle of clinical trial contract and budget escalations across our global portfolio. This role provides strategic direction, oversight, and management of the Clinical Trial Contracts and Budgets function, ensuring operational excellence and compliance with all relevant regulations. The Director will optimize processes, serve as the primary escalation point for contract and budget issues, and drive the development and lifecycle management of Master Clinical Trial Agreements (CTAs) and rate cards. This position collaborates closely with internal stakeholders including; Legal, Data Privacy, Global Regulatory Affairs, and external CRO partners to ensure timely, high-quality execution of clinical trial agreements and budget management, supporting BioNTech’s mission to deliver transformative therapies. Provide strategic leadership for the Clinical Trial Contracts and Budgets function, including resource planning, team development, and performance management. Directly manage, coach, and develop team members, fostering a high-performance culture and supporting professional growth and talent retention. Act as the subject matter expert and primary escalation point for all clinical trial contract and budget issues, ensuring timely and effective resolution of complex negotiations with CRO partners and clinical trial sites. Lead the development, implementation, and lifecycle management of Master CTAs and rate cards, ensuring alignment with company standards, US regulations, and industry best practices. Continuously improve and standardize processes, templates, and fallback language for contracts and budgets in collaboration with internal and external cross-functional stakeholders and strategic partners. Drive operational excellence by identifying and implementing process improvements and automation opportunities to increase efficiency and reduce cycle times. Monitor and analyze contract and budget performance metrics at the portfolio, trial, and site levels; proactively address risks and inefficiencies. Ensure compliance with US and international regulations (e.g., FDA, ICH-GCP), company policies, and industry best practices. Partner with internal and external stakeholders to develop and maintain strong working relationships, ensuring alignment and transparency throughout the contract and budget lifecycle. Provide strategic input in translating protocol elements into efficient and feasible contract and budget development and traceable invoiceables. Support internal and external audits, inspections, and due diligence activities as the subject matter expert for clinical trial contracts and budgets. Develop and deliver training and guidance to team members and stakeholders on contract and budget processes, systems, and compliance requirements. Bachelor’s degree in life sciences, finance, business, or related field required; advanced degree (JD, MBA, MSc, or similar) preferred. Minimum 12 years of experience in clinical research, with at least 5 years in clinical trial contract and budget negotiation/management in the US pharmaceutical, biotech, or CRO environment. Minimum 5 years of direct line management experience, including responsibility for hiring, performance management, and team development. Demonstrated success in people development, including coaching, mentoring, and building high-performing teams. In-depth knowledge of US clinical trial regulations, contract law, and industry standards (FDA, ICH-GCP, Sunshine Act, etc.). Proven ability to develop and implement standardized processes and drive operational excellence. Strong financial and contract acumen. Excellent communication, analytical, and critical thinking skills. Proficiency with contract management and clinical trial management systems. Demonstrated self-starter and team player with strong interpersonal skills. Experience with digital tools, automation, or process optimization in contract/budget management is a plus. Willingness to travel as required (less than 15%). Expected Pay Range: $168,100/year to $268,700/year benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities. BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30 hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: Medical, Dental and Vision Insurance Life, AD&D, Critical Illness Insurance Pre-tax HSA & FSA, DCRA Spending Accounts Employee Assistance & Concierge Program (EAP) available 24/7 Parental and Childbirth Leave & Family Planning Assistance Sitterstream: Virtual Tutoring & Childcare Membership Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown. 401(K) Plan with Company Match Tuition Reimbursement & Student Loan Assistance Programs Wellbeing Incentive Platforms & Incentives Professional Development Programs Commuting Allowance and subsidized parking Discounted Home, Auto & Pet Insurance …and more! More details to be shared.

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