Associate Director* Clinical Development

Open for hire at one of the following locations –  Mainz Goldgrube, Cambridge Erie Street, London. - Job ID: 6744 

Join our team of pioneers!

As a part of our team of more than 5.000 pioneers, you will play a key role in developing solutions for some of the most crucial scientific challenges of our age. Within less than a year, we were able to develop our COVID-19 mRNA vaccine following the highest scientific and ethical standards – writing medical history.
 
We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Associate Director* Clinical Development 

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)

Benefits for you

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.

Click here to find out more about what we do, the careers we offer and also the benefits we provide.
Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

Have we kindled your pioneering spirit? 

This vacancy is to be hired at one of the following locations – Mainz Goldgrube, Cambridge Erie Street, London. Apply now for your preferred job and location through our careers site.

*BioNTech does not differentiate on the basis of race, colour, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, veteran status, genetic information, or any other characteristic protected by applicable law. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!