As the Clinical Development Manager, you will lead clinical activities across the company (e.g., clinical development plans, clinical synopses, clinical study protocols, Investigator Brochures, clinical study reports, clinical contributions to regulatory briefing books and regulatory response documents, etc). Reporting to the Head of Clinical Development, you will maintain key relationships within the company’s Drug Development Teams, as well as with external experts and key opinions. The role has responsibilities within the clinical development team, as well as, with external vendor relationships (CROs, clinical consultants, statisticians). Your role will include direct management of clinical studies for internal projects and participation in co-development for joint partnership projects.
- Elaborate clinical development plans in close collaboration with the Product Development, Regulatory Affairs, and Non- Clinical Development teams.
- Present business cases, defend and get endorsement of the clinical strategic plans from the appropriate governance committees of the company (Development Committee, Strategic Investment Committee).
- Support and mentor the different functions within the Clinical Team.
- Ensure that the operational Clinical Development process is aligned with the company’s Standard Operation Procedures (SOPs), and help improve current SOPs.
- Ensure the pharmacovigilance process of safety surveillance during clinical development and the safety risk management plan are implemented according to industry standards.
- Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities.
- Support the Drug Development Operations department to develop Medincell’s position as a center of Clinical Excellence for external partners and other key stakeholders.
- Manage the clinical development process from early-stage development until product approval and provide clinical leadership to support the clinical development, filing, approval, and commercialization of the new products.
- 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 Practices (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 .
- Actively support the regulatory submission process with appropriate clinical input.
- Take the lead for the preparation and submission 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 (synopses, protocols, investigator brochures, clinical study reports), CTD submissions, interactions with governance bodies, external clinical and medical experts and committees.
- Prepare for and represent MedinCell at regulatory meetings (FDA, EMA, or other regulatory bodies) when clinical input is required.
- Develop deep clinical expertise and knowledge of our product portfolio.
- Foster scientific exchange and raise the scientific profile of MedinCell.
- Develop trust-based relationships with highly respected scientists, physicians renown principal investigators etc.
- Ideally, you will be a Qualified Medical Doctor, However, a PhD with experience in a similar role would also be considered.
- Minimum 5 years of clinical development experience in the Pharmaceutical Industry.
- Relevant experience in CNS or pain management is a plus.
- 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 is a plus.
- 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, synopses, clinical protocols,
- 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,
- Fluency in English, business French is a plus,
- Demonstrated ability to produce high-quality written documents that effectively communicate in a clear, organized and concise manner.