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Clinical Development Director
Our client is a biotechnology company specializing in the development of cell therapy products to address unmet medical needs in orthopedics and other diseases. At the forefront of science and medicine and leader in its field, the company is developing innovative regenerative products, containing bone- forming cells, using its proprietary stem cell-based technology platform. With its strong portfolio of clinical programs (PhaseII and Phase III) and preclinical programs, the company is organized as a “mini-pharma”, with departments for preclinical research, clinical studies, quality control, quality assurance, regulation and administration.
Reporting to the Chief Medical Officer, the Clinical Development Director will be in charge of the overall management and coordination of the process of clinical trials from Phase I to Phase III. This includes the responsibility for creating, organizing, managing the activities of the study team, leading the collaborative development of the projects and external interactions with KOLs, PIs, CROs, regulatory bodies, and filing.
RESPONSIBILITIES AND MAIN ACTIVITIES
- Develop and implement a clinical development strategy to ensure high quality and respect of timelines of clinical trials.
- Develop and approve the final study synopsis, clinical trial protocol, informed consent, CRF, statistical analysis plan, study report, and other clinical trial documentation with support from the Clinical Project Manager and the CRO(s)'s relevant functional representatives.
- Develop clinical sections of the Investigators' brochure, IMPD, CTD and contribute to the writing and review of DSUR, PSUR, RMP when applicable.
- Ensure the medical consistency review of study data, the medical monitoring of adverse events, review of edit checks, data listings, patient profiles.
- Prepare and set up Blinded Data Review meeting(s).
- Ensure up-to-date knowledge of scientific literature and competitive intelligence review.
- Set up and manage Safety Monitoring Committee (SMC) members and develop a SMC charter in collaboration with Pharmacovigilance Department.
- Set up and manage Clinical Advisory Board members in support to the CMO.
- Select third parties’ providers through preparation and management of bid defense meetings, if applicable, negotiate and review final contracts with all the external resources (CROs, Consultants, etc).
- Provide direction and leadership to the project and clinical team. Oversee management of project(s) in terms of quality and compliance to global clinical standards and SOPs, as well as respect of timelines. Identify pitfalls and resolve issues on an ongoing basis by implementing an effective action plan.
- Participate in the selection of clinical operations staff, manage, coach and mentor clinical operations staff members. Prepare and review individual objectives, conduct performance appraisals, and assess training and coaching needs.
- Ensure appropriate, comprehensive and professional communications. Develop publication of investigational products study results.
- Negotiate and create a comprehensive final budget, ensure cost effectiveness by analyzing internal and external costs. Monitor the trial budget quarterly and alert the CMO of non- budgeted expenses needed. Plan and identify resources for global clinical studies based on project timelines and company’s milestones.
- Be responsible for the development and implementation of clinical development processes and systems. Identify emerging trends/regulations in clinical development and integrate these elements into the company’s policies and SOPs.
- Act as a senior level liaison with clients, partners, investigators, KOLs, third parties or subcontractors and interdepartmental within BT.
- Back up for CMO in all activities when needed, providing estimated timelines of development, as well as supporting due diligences with potential partners.
Skills and personality
- Medical Doctor degree required.
- Minimum 3 to 5 years' experience in clinical development (Pharma, biotech or CRO).
- Project management skills.
- Quality and results orientation with a documented track record of successful achievements.
- Direct hands-on experience with a strong pragmatic approach in managing high quality clinical trials. Previous experience in managing projects and people and the ability to provide leadership and guidance to staff.
- Excellent knowledge of global clinical trials regulations and guidelines (GCP guidelines, FDA regulations, ICH guidelines, local laws, etc.).
- In depth knowledge of the preclinical and clinical drug development process.
- Excellent organizational, communication (strong team-related and interpersonal) and negotiation skills as well as the ability to motivate and direct others within a matrix environment.
- Effective collaboration with the clinical project managers/project leaders, members of the clinical operations study team, cross-functional team members and external partners.
- Excellent team management and leadership skills.
- Strong analytical, computer and management skills; project management software skills are a plus.
- Ability to understand and explain to others the clinical details of research as explained in protocols, forms and instruction manuals; ability to communicate goals and to drive effort, overcome obstacles and achieve results.
- Ability to coordinate a variety of tasks in a highly diverse and fast paced, team environment, with attention to detail.
- Willingness to travel (up to maximum 25%, depending on COVID evolution)
- Languages: excellent English, French is a real plus.
minimum 3 years
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