Associate Director, Clinical Trial Management

Cambridge, US;
Gaithersburg, US;
New Jersey, US | full time | Job

Your main responsibilities are to lead one or more complex/large scale clinical trials in either early or late stage clinical development within a program, lead communications, issue escalations, and help the teams within the program to further develop. You will manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables, manage clinical study timelines for the program(s), and ensure inspection readiness throughout the clinical program lifecycle.

May be responsible for line management of one or more direct reports.

• Lead one or more complex/large scale clinical trial(s) in either early or late stage clinical development within a program
• Lead communications, issue escalations and help the teams within the program to further develop
• Manage the Clinical Research Organization (CRO) and vendor(s) as it relates to clinical program level deliverables
• Manage clinical study timelines for the program(s)
• Ensure inspection readiness throughout the clinical program lifecycle
• May be responsible for line management of one or more direct report

• Minimum 8 years of experience in pharmaceutical/biotech or related industry with at least 6 years experience in Global Clinical Development leading cross-functional teams
• A Bachelor’s degree in the life sciences or a university degree in a related field with experience in the health industry. Advanced degree preferred
• Preferred experience with personalized mRNA vaccines in oncology clinical studies
• PMP or equivalent certification desirable
• Knowledge and experience working with legislation and international guidelines (ICH-GCP/CFR) for the performance of clinical research projects
• Involved with addressing regulatory inspections or internal process audits
• Involved in drafting/reviewing responses to Health Authority and Ethics committee questions
• Good listening and communication/presentation skills both written and spoken inclusive of confident, articulate, and professional speaking abilities
• Able to communicate strategy and decisions across different functions
• Standard use of Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring
• Skilled in using Microsoft Office programs (Word, Excel, Power Point, MS Project) as well as good working knowledge of electronic data systems and technical solutions such as eTMF, IWRS, EDC, etc. and developing presentation material
• Resourceful and demonstrates high level of problem solving skills. Able to proactively recognize risks and develop mitigations
• Builds a well performing team through developing honest relationships, and generating trust by demonstrating consistency between words and actions. Promotes an open team environment by allowing differing points of view to be expressed
• Proactive in assuming responsibilities even when dealing with ambiguity in a rapidly changing environment

Expected Pay Range: $171,000/year to $209,000/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
• Sitter stream:
  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…