We are looking for a Senior Clinical Development Leader to join our Montpellier, France facility to participate in our on-going success as a financially sound, fast-growing, socially responsible company dedicated to Global Health.
As the Senior Clinical Development Leader, you will lead the clinical activities across the company (e.g., NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc). Currently reporting to the Head of Technical and Pharmaceutical Operations, you will maintain key relationships within the company’s Development Team, as well as with expert physician scientists and key opinions leaders outside of the company. The role has responsibility for the in-house clinical development team as well as for outside vendor relationships (CROs, clinical consultants, statisticians). Your role will include direct management of clinical studies for internal projects and participation with co-development partners for joint projects.
- Define the strategic clinical development plans in close alignment with the Product Development Teams, Regulatory Affairs, and Non-Clinical Development
- Present business cases, defend and get endorsement of the clinical strategic plan with the appropriate governance committees of the company (Development Committee, Strategic Investment Committee).
- Support the different functions within the Clinical Team with his/her expertise and leadership (monitoring, data management, biostatistics, medical writing, pharmacovigilance)
- Ensure that the operational Clinical Development process is aligned with the company Standard Operation Procedures (SOPs) and help to improve current SOPs.
- Ensure the pharmacovigilance process of safety surveillance during clinical development and design the safety risk management plan.
- Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities.
- Support the Technical & Pharmaceutical Operations Department with Continuous Improvement activities, to develop our position as center of Clinical Excellence for Medincell and external partners.
- Manage the clinical development process and teams from early stage development until product approval and provide clinical leadership to support the clinical development, filing, approval and commercialization of the new products.
- Develop and put in place best-in-class clinical practices and team (internal team and external partners)
- Incorporate expert advice, clinical and commercial considerations, and strategic business needs into the design and implementation of clinical development plans
- Define and implement clinical development projects including objectives, work plans, milestones and deliverables
Represent MedinCell in the design, oversight and execution of early stage and pivotal clinical trials in line with Good Clinical Practice (GCP)
- As required, participate in selecting clinical CROs, developing budgets, validating the study implementation plans
- Ensure protocol development from concept to final protocol
- Ensure studies are managed and executed in compliance with GCP/ICH guidelines, regulations, and company SOPs
- As required, interact with investigators, and lead data review, data analysis and clinical study report authoring
- Provide scientific interpretation of data from clinical studies
Actively support the regulatory submission process
- Take the lead for the preparation and submision of the clinical sections of regulatory document submissions and responses (IND/IMPD, BLA/NDA/MAA) in close collaboration with the Regulatory Affairs team.
- Take the lead for the preparation of key clinical documents to be prepared for clinical trials (protocols, reports), CTD submissions, interactions with governance bodies, external clinical and medical experts and committees.
- Prepare for and represent MedinCell in front of FDA, EMA or other regulatory bodies for clinical development topics
Serve as a cross functional leader and subject matter expert on clinical initiatives
- Develop deep clinical expertise and knowledge of our product portfolio
- Participate in Strategic Investment Review meetings providing Clinical Development expertise and plans
- Expand and optimize the labeling of company products in alignment with strategic priorities through smart, targeted and cost-effective clinical research
- Develop trust-based relationships with highly respected scientists, physicians, renown principal investigators etc.
- Participate in academic congresses, investigator meetings and advisory meetings
- Recruit best talents for the Clinical Development team
- Manage people working in the Clinical Development team and secure smooth relationships across the organization to ensure efficacy
- Build, mentor, empower and develop a highly skilled team of professionals and instill high performance standards
- Medical Doctor (MD)
- Minimum (10) years of experience in clinical development in pharmaceutical industry.
- Experience in CNS and/or pain management.
- Strong hands-on experience in all clinical development phases through regulatory approval and life-cycle management
- Experience in working in development partnerships such as co-development agreements.
- Expert knowledge of drug development processes and regulations
- Clinical experience specifically in injectables. Experience in drug delivery systems (DDS) is a plus
Knowledge, skills and abilities
- Clinical development skills:
- Ability to prepare clinical development plans
- Thorough understanding of ICH/GCP guidelines
- Ability to interact with regulatory authorities in multiple markets
- Complete knowledge of clinical study requirements
- Ability to identify and manage Contract Research Organizations (CROs) to implement clinical studies
Leadership, organizational, and problem-solving skills:
- Ability to mentor and coach colleagues to successfully achieve objectives
- Ability to accurately estimate time for specific tasks
- Ability to plan sequential and / or concurrent activities
- Ability to develop and manage budgets
- Ability to determine priorities within project plan
- Ability to manage multiple priorities with tight deadlines
- Ability to anticipate and resolve issues on a daily basis
- Ability to work effectively across multiple project teams in a matrix environment to reach overall business goals
- Ability to work in a diverse environment with different stakeholders
Strong interpersonal skills for:
- Managing relationships and communication exchanges internally and with co-development partners
- Effectively preparing and leading meetings internally and with third-parties in English
- Effective international collaboration
- Fluency in speaking and writing English
- Good understanding of spoken and written French preferred
- Demonstrated ability to produce high quality written documents that effectively communicate in a clear, organized and concise manner
- Highly collaborative cross-functional approach
- Results orientation with focus on timely delivery and sense of urgency
- Effective functioning in a rapidly evolving environment and adherence to the values, principles and mission of the company
- High degree of autonomy
- Strong listening skills
- Openness and ability to adapt to changing situations
- Desire to continuously improve and progress
- Strong work ethic