This role will be a key contributor to the company’s clinical development and primarily responsible for the hands-on management and monitoring of early and late-stage clinical studies in ultra rare disease indications. This position reports to the Senior Director of Global Clinical Research Operations and will work closely with Program Management and Medical and Commercial Operations in the creation and management of the clinical development plans for rare disease programs and ultimately, driving the planning activities to ensure successful execution and completion of the clinical trial(s).
The Associate Director Clinical Operations leads the clinical trials implementation and has oversight of clinical trial CROs and clinical laboratory vendors. This individual will also drive clinical sub-team meetings and collaborate with Clinical Research and Medical Operations to complete the following:
o Identification and management of Clinical Research Organization(s) and other contractors as needed.
o Protocol feasibility analysis, country assessment, site identification, and patient recruitment planning.
o Identification of investigators and providing assistance to facilitate timely selection of investigators and sites.
o Recruitment of patients and management of logistics for getting patients to sites for clinical trials globally.
o Site selection, site monitoring and recruitment plans.
o Preparation and review of the protocol, CRFs, and informed consent forms.
o Preparation of the coordinators manual, pharmacy manual and other documentation required for the conduct of the global clinical trial(s).
o Collection and review of essential documents for study start-up.
o Ensuring documents remain current during the course of the trial.
o Maintaining internal trial master file to ensure inspection readiness.
o Interaction with investigators to obtain necessary documentation and information before, during and after the study. Ensuring accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete and can be used as a source of reference.
o Ensuring that the site personnel have a good understanding of the protocol and provide CRA training.
o Maintaining project tracking system on an ongoing basis to ensure that progress regarding the sites can be tracked.
o Assisting with the preparation and presentation at investigator meetings as required to ensure that the clinical and investigational site staff team is well informed about the study and related procedures.
o Preparation and management of detailed project plan in MS Project and clinical study budget.
o Establishment and consistent use of clinical project planning processes.
o Interfacing with Program Management, Medical Operations and Commercial to develop integrated clinical and commercial plans.
o Representing Clinical Research in presentations to Senior Management.
o Providing clinical input into the preparation of clinical portions of project INDs and other regulatory submissions.
o Creation of didactic presentations as needed to educate team members on disease background.
o Providing regular status updates of project progress to Head of Program Management and Chief Medical Officer.
o Educated to degree level (biological science, pharmacy or other health related discipline preferred) or equivalent nursing qualification/experience.
o Minimum 7+ years of industry experience within clinical research/operations.
o Experience managing global clinical trials in rare diseases with orphan drug designation is strongly preferred.
o Demonstrated success in managing clinical study start-up for rare or ultra rare disease programs is strongly preferred.
o Proven track record of successfully delivering projects on time, to budget and the required quality.
o Excellent interpersonal, verbal and written communication skills (including experience in making presentations).
o Able to take initiative and work independently; sense of urgency in completing assigned tasks.
o Flexibility towards work assignments, new learning and travel (overnight, weekend and international travel may be required). Flexibility to accommodate travel up to 25-30%.
o Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
o Team player with outstanding interpersonal, negotiation skills and organizational skills.
o Computer Proficiency: MS Office suite and working knowledge of MS Project required.
Synageva BioPharma is a publicly traded biopharmaceutical company with headquarters, research and development facilities in Lexington, MA, and research and production facilities in Athens, GA. Synageva is dedicated to developing novel orphan treatments for rare diseases. Our lead program, sebelipase alfa, an enzyme replacement therapy for LAL Deficiency, is in global clinical trials and has been granted orphan designation by the FDA, the European Medicines Agency, and the Japanese Ministry of Health, Labour and Welfare. LAL Deficiency is a rare, serious and devastating disease that leads to significant morbidity and mortality. Synageva has additional orphan products in various stages of preclinical development. To ensure that these therapeutic candidates reach patients in need, Synageva has recruited a team with a proven track record of manufacturing, discovery, development, and commercial success within rare diseases.
Our mission is to deliver breakthrough medicines globally for patients suffering from devastating diseases. Achieving this will result in a sustainable business that can continue to positively impact the lives of patients and their families, healthcare providers and our employees. Our success depends upon our ability to seek and retain principle-minded individuals who share our integrity, drive, energy and passion.