Clinical Lead – I&I

Clinical Lead – I&I

Requirements

• Medical Doctor (MD): Experience in internal medicine and immune driven diseases
• Fluency in written and spoken English
• Clinical development in the field of autoimmune diseases
• Understanding of pharmaceutical product development and life cycle management gained through ~5-10 years of development and medical experience
• Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies
• Ability to influence and negotiate to ensure operational resources are available for continued clinical conduct
• Strategic leadership and understanding of the drug development value chain
• Excellent teaching skills, demonstrated ability to assist and train others
• Ability to work within a matrix model
• International/ intercultural working skills
• Open-minded to apply new digital solutions

Responsibilities

• Lead the clinical development plan strategies and implementation for auto-immunity programs in I&I indications and coordinate clinical activities across indications and TAs
• Lead a clinical team including CRDs and clinical scientists
• Oversee and support study related clinical activities, e.g. protocol development, pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment
• Support and input preparation of internal governance milestones
• Oversee and contribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Coordinate with CRDs in the project, Global Project Head, The PV Rep, Regulatory
• Develop and assess clinical scenarios in alignment with GPH
• Preparation of documents and presentations for internal governance meetings
• Collaborate with CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams
• Contribute to the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
• Engage and collaborate with internal and external partners, regulators, and experts
• Lead and oversee study implementation and remediate study issues
• Review and validate the clinical study report and key results memos
• Oversee and is accountable for study related clinical activities
• Develop the abbreviated protocol
• Review and validate the final protocol, protocol amendments and study supporting documents
• Co-Develop the SAP in collaboration with bio stats
• Responsible for key results preparation and clinical study report
• Assisted by related functions (e.g. clinical operations, project management, and procurement), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
• Medical support to clinical operation team during the clinical feasibility
• Ensure continuous medical review of aggregated data during clinical trial conduct (DRSR, safety, stat outputs of blinded data, …) with clinical scientist, bio stat and GSO
• Lead the study specific committees (IDMC, steering com, adjudication …) with operational support
• Answer to medical questions raised by EC/IRBs, sites
• Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project
• Oversee and is accountable for clinical input in key regulatory documents : Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
• Supports registrations, label submissions and modifications: Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
• Act as a TA level expert/referent in the field of autoimmunity
• Evaluates relevant medical literature and status from competitive products
• Support the planning of and participates to advisory board meetings
• Participate and author manuscripts and abstracts
• Establish and maintains appropriate collaborations with knowledge experts

Preferred Qualifications

No preferred qualifications provided.