Medical Director/ Clinical Research Physician
Job Title: Medical Director/ Clinical Research Physician
Department: Medical and Safety Scientist
Reports To: Executive Director Product Safety & Clinical Development
Location: Durham, NC
Accountable for quality of medical and scientific conduct of assigned Phase I - III clinical studies and/or drug product development.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for medical oversight of Phase I - III site protocols in assigned clinical trials
- Responsible, together with Clinical Managers, for the adequacy of clinical and laboratory monitoring schedules in study protocols
- Responsible, together with Clinical Managers, for the quality of CRF templates and site tools
- Responsible for oversight of the ethical conduct of assigned protocols.
- Responsible for medical monitoring including appropriate subject inclusion into protocols, review of clinical and laboratory findings in ongoing clinical trials, and responding to medical queries from investigators and sites
- Responsible for oversight of site compliance with eligibility criteria and study-specific procedures
- Responsible for detection and communication of adverse trends in any aspect of study conduct
- Responsible for communicating with CRO staff and sites as needed to understand clinical and laboratory findings
- Accountable, together with Clinical Managers, in reviewing site monitoring and audit reports and driving necessary corrective actions
- Responsible for original writing, editing and review of medical and scientific elements of clinical research documents to ensure accuracy, consistency with standard of care, logistical ease, and internal consistency, as assigned
- Responsible for investigator and site staff education on the medical and scientific aspects of protocols, as assigned With oversight, provides medical and safety input and or authors sections of clinical/regulatory documents such as Clinical Study Reports (CSRs), IND/NDA submissions, Product Labeling and promotional materials.
- Medical leadership on the Product Team, and where assigned, leadership team and BOD interactions on the project.
- Medical leadership in presenting the product externally to academic, regulatory, prescriber, government, and payer communities.
- Provides medical support in corporate partner interactions on assigned projects.
- Responsible for Data Monitoring Committee interactions on assigned projects.
Responsible for ongoing safety oversight
- Responsible for review of all adverse events for assigned protocols and/or products
- Responsible for coding review of medical history, adverse events, and concomitant medications
- Accountable, together with Safety Officer, for detecting and communicating adverse safety signals
- Responsible for communicating with CRO staff and sites as needed to understand adverse events
- With oversight, integrates drug safety with (and supports) clinical development teams, to deliver proactive, integrated and comprehensive drug safety service during all phases of clinical development on assigned products.
- With oversight, contributes or develops an objective, defensible and medically sound Drug Safety view on assigned product safety issues.
- Contributes to the development and implementation of safety review processes for assigned products, to ensure ongoing risk/benefit of all products.
- Contributes to the development and implementation of Post-marketing Surveillance Programs, including Risk Evaluation and Mitigation Strategies (REMS) when required, for assigned marketed products.
- Working with the Clinical Teams, coordinates activities with outsourced partners regarding management of safety data on assigned products to ensure compliance with relevant regulations and guidelines.
- Identifies and evaluates external epidemiologic data sources as required.
- With oversight, contributes to post-marketing surveillance and analysis on assigned products.
Responsible for providing medical and scientific expertise to clinical-regualtory Teams, as assigned
- Contributes to the development of clinical research documents
- Co-authors internal presentations and briefings
- Co-authors external presentations, posters and manuscripts in collaboration with principal investigators
- Attends appropriate scientific meetings and stays up to date with relevant scientific literature to maintain expertise
- Provides scientific and medical insights relevant to assigned projects
- Contributes as needed to scientific and medical thinking for other projects
- Supports medical and regulatory review and approval of promotional, labeling, and training materials
- MD with postgraduate training and 2 years clinical experience with direct patient care responsibilities. Board board-eligible or board-certified in a specialty or relevant subspecialty preferred.
Experience and role-specific skills
- Demonstrated industry experience in clinical research, including medical monitoring, minimum 7 years preferred
- Demonstrated track record of scholarship, independent research funding, publication, and/or membership in scholarly societies
- Understanding of the clinical research process and its intricacies
- Experience with anticipating and solving the practical issues encountered in execution of clinical trials
- Strong leadership and process improvement skills
- Excellent interpersonal communications, organization and presentation skills
- Strong quantitative skills, including solid familiarity with statistical and epidemiological concepts (record of publication in the field is desirable).
- Able to maintain professional skills, and learn new ones when necessary.
- Understanding of the clinical-regulatory-commercial development process and its intricacies
- Ability to manage multiple projects and maintain timelines
- Ability to work in cross-functional teams
- Deep familiarity with ICH and GCP guidelines
- Familiarity with safety reporting requirements per US and European regulations
- Experience with global regulatory authorities in one or more major markets including USA (FDA), Europe (EMA) and Japan (MHLW)
- Excellent written and oral communication, interpersonal, and organizational skills
- Initiative in producing high quality work product in a small company environment
- Roll-up-the-sleeves attitude
- Strong project management skills
- Ability to understand, influence, and collaborate in a diverse team-based organization
- Competence with standard office computer software tools
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local laws.