Senior Director, Global Clinical Operations

Threat Intelligence SpecialistSecurity AnalystFull TimeRemote

Location

United States + 2 moreAll locations: United States, United Kingdom, Germany

Posted

20 days ago

Salary

Not specified

No structured requirement data.

Job Description

The Senior Director Global Clinical Operations is responsible for the planning and strategic set-up of the Clinical Operations team, including planning of required resources as well as relevant vendors and systems. The Sr. Dir leads the Clinical Operations team and is the point of escalation for the Director/Sr. Director Global Clinical Operations for clinical trial activities and line management tasks. Oversees all aspects of clinical trial execution within a set of therapies defined as a “portfolio” within BNT pipeline (includes multiple platforms). Highly skilled at strategic operational execution, effective communication with senior leadership as well as vendor & stakeholder management. Your Contribution: Accountable for the continuous adaptation of clinical operations needs and internal departmental processes for the rapidly growing organizations within BioNTech. Represents clinical operations in interaction with international collaborations with pharma partners and other collaboration partners. Actively driving Governance Vendor Oversight for the main Clinical Research Organizations (CROs) working for BioNTech, running steering committees and control activities to ensure the required compliance. Profound experience with the preparation and processing of national and international business experience in clinical operation and clinical development processes. Actively exchanging and communicating with upper management, related internal departments and external departments and collaboration partners. All clinical operations strategies need to be developed under consideration of the local laws, international guidelines (ICH GCP). Excellent communication and problem-solving skills are part of the job. Oversees activities related to leading the team, oversight of third-party providers, the timely performance of all services, as well as the problem management by interacting with all departments involved. Initiation of development and review of portfolio documents such as Oversight Plans, Process Developments (including Trial RACI) and SOP development. Supervision of the direct reports for adherence to the regulatory requirements, ICH-GCP guidelines, relevant procedures and conduct of respective training. Opportune contact to upper management, Clinical Development and other departments. Instruction and supervision (line Management). Resource planning in alignment with GCDO and GDO. Involved in the governance structure and oversight with CROs and vendors. Contributing to the process of selection and decision on participation of vendors, preferred vendors and partnership vendors for strategic sourcing. Oversight on overall project/program timelines and deliverables and identification future of program needs. Team developments, performance management, identification of high-performance team members and working on team development together with GCDO LT. Adherence to the regulatory requirements, the ICH-GCP guidelines and the respective procedures (i.e. policies, SOPs, instructions).

Job Requirements

  • A Bachelor’s degree in life sciences or a university degree in a related field with experience in a medical profession. Advanced degree preferred (Masters, PhD, MD, PharmD).
  • Global clinical trial experience in all phases (phase I-IV).
  • Over 8 years’ experience directly managing people.
  • PMP or equivalent certification desirable.
  • Expert knowledge and experience working with global international guidelines (ICH-GCP) for the performance of Clinical Development Programs.
  • Strong Compliance focus with Direct experience involved in addressing regulatory inspections or internal process audits.
  • Involved in drafting/reviewing responses to Health Authority and Ethics committee questions.
  • Over 15 years’ experience in pharmaceutical/biotech or related industry with at least 10 years in Global Clinical Development with experience preferred in the lifecycle development of Infectious Diseases in LMICs and Oncology programs.
  • 10 years of Global clinical trial experience in all phases (phase I-IV).

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.
  • How to apply
  • Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.
  • Please note: Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations.
  • If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.
  • We are looking forward receiving your application.

Related Job Pages

More Threat Intelligence Specialist Jobs

Threat Intelligence Specialist20 days ago
Full TimeRemote

Looking for architects with 10+ years’ experience in payments domain (ideally at an acquirer or network working in core payments processing) and ideally with some first hand experience in: Designing target architecture for a company with a starting point of significant duplicate ...

United States
Threat Intelligence Specialist20 days ago
Full TimeRemote

Looking for architects with 10+ years’ experience in payments domain (ideally at an acquirer or network working in core payments processing) and ideally with some first-hand experience in: Designing target architecture for a company with a starting point of significant duplicate ...

United States

Sales Intelligence Analyst

Wipfli

Wipfli is an advisory firm that delivers holistic solutions to help clients navigate the modern marketplace, optimize performance and drive growth. Our more than 3,000 full-time associates deliver digital, people, strategy, risk, financial and outsourcing solutions to 54,000+ clients. "Wipfli" is the brand name under which Wipfli LLP and Wipfli Advisory LLC and its respective subsidiary entities provide professional services. Wipfli LLP and Wipfli Advisory LLC (and its respective subsidiary entities) practice in an alternative practice structure in accordance with the AICPA Code of Professional Conduct and applicable law, regulations, and professional standards. Wipfli LLP is a licensed independent CPA firm that provides attest services to its clients, and Wipfli Advisory LLC provides tax and business consulting services to its clients. Wipfli Advisory LLC and its subsidiary entities are not licensed CPA firms.

Threat Intelligence Specialist21 days ago
Full TimeRemoteTeam 3,000Since 1930

Support sales intelligence by collecting, preparing, and analyzing sales and marketing data; maintain dashboards and data quality; run pipeline and win/loss analyses; translate findings into clear visualizations and reports for stakeholders.

SQLMicrosoft Dynamics 365ExcelPower BiDaxSnowflakeDatabricksFabricPythonData WarehouseSemantic Models
United States
$73K - $98K / year
Threat Intelligence Specialist21 days ago
Full TimeRemote

We are seeking an experienced Epic Tapestry Utilization Management Analyst to design, build, optimize, and support UM processes focused on authorizations and referrals. The ideal candidate is Epic Tapestry UM Certified, has practical experience with Tapestry Care Link, and is ade...

United States