Associate Director Clinical Development (all genders)

Mainz, Germany; Berlin, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom   |   full time   |   hybrid   |   Job ID: 6744 

Responsibilities.

· Works hand-in-hand with the VP of Clinical Development to support development of clinical strategies, plans and their operationalization especially on trial level.

· Drives the operational planning, content, execution and delivery for our programs and studies. Will manage day-to-day clinical activities for our clinical studies including management of protocol amendments, overseeing data review activities and communicating with investigator / sites where appropriate.

· Assumes Program Lead responsibilities if assigned as clinical lead for a program; working hand-in-hand with VP Clinical Development to develop and implement CDP. Supports 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 drives alignment on objectives and expected outcomes especially on a protocol and clinical study level

· Contributes to the trial medical/ safety aspects and risk-benefit assessments supported by the Clinical Trial Scientists and Pharmacovigilance. Collaborates closely with Pharmacovigilance on development of Risk Management Plans

· Collaborates and gives guidance for the Clinical Trial Scientists, and works with them on day-to-day basis on clinical trials, driving overall progress of study implementation

· Supervises and gets involved in ongoing medical data review, ensures medical queries of running studies are resolved

· Ensures on program (where appropriate) and trial level, that the clinical development team works hand-in-hand with Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations

· Collaborates with other partner functions in Development on the acceleration of program and trial design and innovation for the patient (e.g. digital endpoints, synthetic control arms, RWE/ HEOR, PRO, Medical Affairs)

· Creates input for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs

· Writes/ co-writes Clinical Study Report (CSR) medical content and ensures it meets high quality expectations on medical standards

· Manages relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities), where appropriate

· Represents the team to decision/ governance meetings, senior management, or advisory boards as applicable

· Contributes to a collaborate culture within and outside Clinical Development and actively manages best practice sharing and capability building within the clinical team

What you have to offer.

· M.D. with scientific and clinical background in Immuno-Oncology, Oncology 

· Minimum of 3 years+ of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and/or the academic setting, including management of clinical development activities

· Good understanding of the clinical and scientific methods and approaches used in clinical development, from FIH to registration; experience with regulatory processes and registration a plus

· Experience in contributing to trial designs and protocols

· Hand-on experience in managing the clinical day-to-day work for the successful delivery of clinical trials

· Experiences in preparing global health authority interactions (e.g. EMA, FDA)

· Experience in overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects

· Ability to plan clinical activities based on a TPP and CDP guidance, and translating them into trial designs

· Experiences with working in a matrix environment (global and cross-functional)

· Experience in collaborating and communicating with external collaboration partners like KOLs and investigators

· Good understanding of the science supporting the clinical development programs. Confident to discuss and present scientific and mechanistic aspects of drug development

· Subject matter expertise on drug development topics, and genuine interest to drive innovation and continuous improvement

· Proficiency in English (written and spoken)

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; Berlin, Germany; Cambridge, US; Gaithersburg, US; London, United Kingdom location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6781 9855 211 (Monday-Friday from 12 PM to 4 PM CET).

Job ID 6744 (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 Recruiter.