Apply on Employer Site

BioNTech SE · 1 day ago

Director, Global Clinical Operations

Cambridge, MA

Full-time

Onsite

Director/Executive

$168K/yr - $259K/yr

12+ years exp

BioNTech SE is a leading biotechnology company focused on developing innovative therapies. The Director, Global Clinical Operations provides leadership and strategic management of clinical development operations, overseeing multiple therapies and ensuring high-quality execution across clinical studies and vendors.

Health Care

Responsibilities

Platform Lead: Oversee one to several therapies defined as a “platform” within BNT pipeline

Ensure consistent, high quality execution across compounds and vendors. Global study management and vendor oversight required with experience managing direct reports

Contribution to development and review of portfolio documents such like Oversight Plans, Process Developments (including Trial RACI) and SOP development

Supervision of the project team member’s adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training

Responsible for the overall success of the clinical study team(s) within a program(s)

Provides operational insight into feasibility, timeline and cost estimates during clinical program/study development

Ensures timely delivery of quality operational deliverables and accountable for ensuring consistency of process and approaches across clinical study teams within the clinical program(s)

Key point of contact for clinical platform and study level escalation within the platform

Provides innovative and flexible operational solutions and options to the teams; assists in preparing scenarios for creative solutions to operational challenges

Responsible for CTM resource forecasting and resource allocation for clinical studies across one or more clinical programs

Responsible for line management of CTM and/or CTS staff (e.g. performance management, staff recruitment, professional development, coaching, mentoring, ongoing training and compliance, etc.)

Point of escalation in case of challenges in project activities with other sponsor departments or external vendors

Resource planning of the team in alignment with the SDGCO

S/He is involved in the governance structure and oversight with CROs and vendors

Strategic contribution in the process of selection and decision on participation of vendors, preferred vendors and partnership vendors

Oversight on overall project/program timelines and deliverables and identification future of program needs

Organization and conduct of Platform or executive level meetings

Team developments, performance management, identification of high-performance team members and working on team development together with the SDGCO

Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions)

Qualification

Global Clinical DevelopmentPMP CertificationICH-GCP GuidelinesMicrosoft OfficeProject ManagementTeam DevelopmentAnalytical SkillsCommunication Skills

Required

A Bachelor's degree in the life sciences or a university degree in a related field with experience in a medical profession

Minimum 12 years of experience in pharmaceutical/biotech or related industry with at least 8 years in Global Clinical Development leading cross-functional teams

Profound knowledge and experience working with 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

Strong communication and presentation skills both written and spoken inclusive of confident, articulate, and professional speaking abilities

Able to communicate strategy and decisions in a manner that fosters collaboration and partnerships across different functions

Empathic listener and persuasive speaker

Standard use of Project Management skills including teamwork, analytical and problem-solving, time management and organizational skills, risk and cost management, and performance monitoring

Advanced skills in Microsoft Office programs (Word, Excel, Power Point, MS Project) as well as knowledgeable of electronic data systems and technical solutions such as eTMF, IWRS, EDC, etc. and developing presentation material

Successfully develops strategic direction for clinical programs and sets objectives and priorities in alignment with the program goals

Identifies potential opportunities and manages risks

Builds high performing teams through talent development and coaching, developing honest relationships, and generating trust by demonstrating consistency between words and actions

Maintaining integrity under pressure and being a role model to promote an open environment

Proactive in assuming responsibilities even when dealing with ambiguity in a rapidly changing environment

Capable of maintaining a current and strategic view of talent management, aligned with company priorities and needs