Associate Director, Clinical Development

Primary responsibilities:

• Participate in the design and execution of clinical trials of their assigned programs, helping to create the clinical development plan for new compounds, and pave a path towards regulatory approval. 
• Works hand-in-hand with the (Senior) Director Clinical Development to drive clinical strategies and their operationalization in programs and trials. 
• Collaborative with other functions in operational planning, content, execution and delivery for assigned programs and studies. Will manage day-to-day clinical activities for our clinical studies including management of protocol amendments, overseeing data review activities, conducting medical data review and communicating with investigator / sites where appropriate. 
• Assumes Trial Lead responsibilities in the assigned programs, in liaison with the responsible program manager. Collaborate with the program core team. 
• Contribute to create and translate Target Product Profile into clinical strategy. 
• As Trial Lead, articulates targets of TPP and CDP to other development functions (e.g. Regulatory, Pharmacovigilance, Statistics, etc.) and drives alignment on objectives and expected outcomes. Helps translate Target Product Profile into clinical strategy. 
• 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.
• Responsible for developing data review strategy and conducting ongoing medical monitoring activities including medical data review.
• Support preparation and participate in study level meetings, for example investigator meetings, data monitoring meetings, and others.Ensures at the program and trial level, that the clinical development team works hand-in-hand with Clinical Operations team, with a focus on patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations. 
• Takes ownership together with partner functions in Development on the acceleration of program, 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. 
• Creates Clinical Study Report (CSR) medical content and ensures it meets high quality expectations on medical standards, provides respective guidance to other members of the clinical development team
• Establishes and manages relationships with key external stakeholders (industry partners, Key Opinion Leaders, health authorities). 
• Participant decision/governance meetings, senior management, or advisory boards as applicable. 
• Contributes to a collaborate culture within and outside Clinical Development and actively share best practice within the clinical team.

Required Knowledge, Skills, And Abilities.

• M.D. with strong scientific and clinical background in Immuno-Oncology, Oncology 
• Minimum of 5 years of experience within Immuno-Oncology, Oncology at the biotech/pharmaceutical and the academic setting, including leading clinical development programs from exploratory Phase I/II clinical studies through late stage development in Phase III and regulatory submissions. Total 8 years’ experience in related area.
• Good understanding of the clinical and scientific methods and approaches used in clinical development studies, as novel clinical study designs, application of companion diagnostics for patient selection, clinical pharmacology/ translational modeling and biostatistics. Complemented with several years of experience on confirmatory PH3 trial design and respective dossier preparation and submission activities. 
• Experienced in global health authority interactions (EMA, FDA, MHRA, CDE). Having participated or led a drug development program to successful registration is an advantage. 
• Strong medical experience in medical monitoring including overseeing and interpreting safety and efficacy clinical trial data and ensuring appropriate contact for study medical and patient safety aspects. 
• Ability to strategize clinical activities based on a TPP and CDP and translate into trial designs
• Ability to write high quality and executable trial designs and protocols
• High level of comfort and demonstrated successes working in a matrix environment (global and cross-functional), including contributing to establishing clarity and structures and driving state of the art collaborations with external academic and industry partners.
• A genuine interest and 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
• High proficiency in English (written and spoken)