Director, Medical Monitor - San Francisco, United States - Prothena Biosciences

Description

The Director, Medical Monitor will provide oversight of medical activities that span across the clinical trials that are being conducted by Prothena and will be accountable for the design and conduct of clinical trials, will review and/or generate key study documents (such as medical monitoring and safety management plans, etc.), will assess and interpret safety data, and will contribute to investigator, or other site staff and clinical study team training.

• Develop and/or review operational, medical monitoring, treatment manuals, and safety plans for studies; participate in the development and revision of medical monitoring SOPs
• Review study protocols and conduct ongoing medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed
• Consult with internal and external stakeholders in the development of clinical trial design and conduct including drafting of protocols, and amendments
• Primary responsibility for the content and completion of clinical trial documentation, e.g., protocol and amendments, investigator brochures (IB), informed consent forms (ICF), and case report forms (CRFs)
• Responsible for the clinical portion of health authority meeting packages, clinical study reports (CSR), safety narratives, newsletters/communications to study sites, DSURs, BLA/MAA/NDA
• Key participant in study start-ups, study database locks, data cleaning, study result interpretations, and study close-out
• Review all adverse events to look for trends or risks; review all serious adverse events (SAEs), including review of the narrative, investigators' assessment of causality, and applicable regulatory reporting
• Generate safety-related documents, such as medical data review reports, to ensure that the reporting of SAEs is current and complete
• Support drug safety monitoring boards
• In collaboration with others on the study management team, ensures the Trial Master File (TMF) remains up to date as well as in compliance with the overall study data quality plan
• Review and analyze the eligibility of participants per inclusion/exclusion requirements of a clinical trial
• Will participate and present, as needed, during interactions with key opinion leaders (e.g., on Steering Committees, DSMBs, and Advisory Boards), investigator meetings, health authority meetings, study site visits, site training, and health authority inspections
• Participate in global/program level governance committee reviews
• Act as the main point of contact for Investigators for medical and protocol related questions
• Provide medical knowledge and expertise to the day-to-day operations of clinical research studies by answering medical questions coming from the study team or the CROs
• Be readily available to advise on assigned clinical trial related medical questions or problems during the conduct of the trial
• Maintain current knowledge about both internal and external developments (e.g. key scientific publications/presentations, current clinical trial design considerations, disease specific clinical trial outcomes, regulatory guidance) that are relevant to the molecule(s) and disease area
• May participate in developing and writing scientific/clinical abstracts, posters, conference presentations, and manuscripts

• MD, DO, or equivalent with a minimum of 5 years direct experience in medical monitoring in a pharmaceutical environment and/or CRO
• Experience in global medical monitoring and program level medical oversight including review of all or critically relevant data for consistency, coherency, reliability, and medical logic and experience in clinical data review; experience navigating scientific literature, interpretation of data, display of data (e.g. JReview, SpotFire, etc.)
• Experience in adult neurology, oncology, internal medicine, or rheumatology preferred
• Hands-on patient care experience is strongly preferred
• Experience in all stages of clinical development from Phase I to Phase III, end-to-end
• Deep knowledge of ICH/GCP guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
• Experience developing and authoring clinical development plans and study protocols
• Preferred experience in preparing documents and/or have attended regulatory meetings with FDA and other regulatory agencies
• Basic knowledge in medical writing, biostatistics, data management, and EDC
• Knowledge of GVPs, GCPs, ICH guidelines, and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirements
• Experience presenting to a wide variety of audiences including internal teams and medical/scientific communities
• Ability to travel (<35%)Competencies and Attributes:
• Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena's culture and values - courageous, imaginative, selfless, and joyful
• Proficient in standard computer software applications (Excel, PowerPoint, etc.)
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communications
• Must be able to work on multiple projects simultaneously
• Demonstrated problem-solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures
• Outstanding attention to detail with solid organizational, prioritization, and time management proficiencies
• Excellent written and verbal communication skills
• Demonstration of strong teamwork
• Ability to work in a complex, matrixed organization
• Ability to build and maintain trust, confidence and communicate effectively with clients, external vendors, and internal team members
• Proactive, action-oriented, and resilient in a fast-paced environment with the ability to build and lead effective project teams, motivate others, delegate, and make and implement decisions

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.

We may ultimately pay more or less than the posted range, and the range may be modified in the future.

The final salary offered to a successful candidate will be dependent on several factors that may include - but are not limited to - the final job level offered, the type and length of experience within the job and industry, relevant education, qualifications, skills, certifications, performance, and business or organizational needs.

The hired applicant will be eligible to receive an annual bonus and an equity grant in the form of stock options.

• All Prothena employees (and their families) are covered by medical, dental, and vision insurance, with Prothena paying ~90% of plan premiums.
• Prothena pays the full premium for basic life and disability insurance for all employees.
• Prothena employees are also eligible to enroll in our Company's 401(k) plan and are always 100% vested in their account balances. The 401(k) plan provides for a quarterly, non-discretionary, 3% company-paid contribution on eligible earnings, as well as an additional, annual discretionary Company match of up to 2% of eligible earnings.
• New Prothena employees are also eligible for 17 days of paid vacation accrued over the course of the first year of employment, paid sick time in accordance with state law, and company-paid holidays - which includes a Company-wide shutdown at the winter holidays.