Director Clinical Development

BioNTech SE; Deutschland; Hybrid; EUR 100.000 - 150.000; Vollzeit

Zusammenfassung

A leading biotechnology company located in Germany is seeking a Director of Clinical Development. The role involves guiding clinical strategies and managing day-to-day clinical activities for trials. Candidates should hold an M.D. and have substantial experience in immuno-oncology and regulatory processes. The position offers flexible working hours and various developmental benefits.

Leistungen

Flexible hours

Digital Learning opportunities

Employer-funded pension

Company bike

Qualifikationen

• Several years of experience in immuno-oncology, oncology and/or infectious diseases.
• Good understanding of clinical and scientific methods used in clinical development.
• Experience in preparing interactions with health authorities.

Aufgaben

• Guide clinical strategies and operationalize in programs and trials.
• Manage day-to-day clinical activities for clinical trials.
• Develop and implement the Clinical Development Plan.

Kenntnisse

Strong scientific and clinical background in Immuno-Oncology

Experience in clinical operations for clinical trials

Experience with regulatory processes

Ausbildung

M.D.

Jobbeschreibung

Mainz, Germany; London, United Kingdom; Munich, Germany | full time | Job ID: 9313

The Director Clinical Development will work hand-in-hand with the VP Clinical Development to implement clinical strategies and operationalize in both programs and clinical trials. He/ She will work on the design and execution of clinical trials from early to late stage development through regulatory approval, horizontally leading a matrix team. This includes thorough data interpretation based on deep scientific and disease biology understanding, translational expertise and medical knowledge, including patient safety and data integrity

Your main responsibilities are:

• Works hand-in-hand with the VP of Clinical Development to guide clinical strategies and their operationalization into programs and trials.
• Drives the operational planning, content, execution and delivery for our programs and studies. Manages the day-to-day clinical activities for our clinical trials, including managing protocol amendments, overseeing data review activities, and communicating with investigators/sites as appropriate.
• Assumes the responsibilities of Study Director when assigned as the clinical lead for a study; works hand-in-hand with the VP Clinical Development to develop and implement the CDP.
• As study lead, articulates TPP and CDP objectives to other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) and drives alignment on objectives and expected outcomes. Drives translation of target product profile into clinical strategy.
• Collaborates with other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) to support clarity on clinical objectives and drive alignment on objectives and expected outcomes.
• Responsible for medical/safety aspects of trials and risk/benefit assessments, supported by Clinical Trial Scientists and Pharmacovigilance. Works closely with Pharmacovigilance in the development of risk management plans.

What you have to offer.

• M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology and/or Infectious diseases
• Several years of relevant experience in immuno-oncology, oncology and/or infectious diseases in a biotech/pharmaceutical and/or academic environment, including leadership of clinical development activities, ideally from exploratory Phase I/II clinical trials through late stage development in Phase III and NDA submission.
• Good understanding of clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus.
• Hands-on experience in managing the day-to-day clinical operations for the successful conduct of clinical trials.
• Experience in liaising with clinical operations and epidemiology on a regular basis for the efficient conduct of clinical trials.
• Experience in preparing and conducting interactions with global health authorities (e.g. EMA, FDA). Participation in drug development activities leading to successful registration is an advantage.
• Strong experience in monitoring and interpreting safety and efficacy clinical trial data and ensuring appropriate liaison for trial medical and patient safety issues.
• Functional and/or disciplinary leadership experience with a proven track record of leading teams is a plus.

Your Benefits:

It's our priority to support you:

• Your flexibility: flexible hours | vacation account
• Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
• Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
• Your health and lifestyle: Company bike
• Your mobility: Job ticket | Deutschlandticket
• Your life phases: Employer-funded pension | Childcare

Apply now - We look forward to your application!

Apply to our Mainz, Germany; London, United Kingdom; Munich, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).

Job ID 9313 (please always specify if you have any questions)

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.

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