Sr. Medical Director, Clinical Development (contract)

JOB SUMMARY:

The Senior Medical Director, Clinical Developmentplays a key role at all stages of clinical development for product programs from the drug discovery stage through product registrations world-wide. The Sr. Medical Director is responsible for medical oversight of Phase I-IV site protocols in assigned clinical trials, ongoing safety oversight and providing medical and scientific expertise to clinical and regulatory teams, and may be consulted or have responsibilities for Phase IV studies conducted by medical affairs if appropriate. Oversees ongoing and planned product trials and the exploration of novel indications. Provides clinical leadership to cross functional project teams on development strategies, clinical study outlines and data interpretation of study results.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Clinical Development Responsibilities Provide scientific and medical insights relevant to assigned programs and projects. 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. Provide medical and safety input and or author sections of regulatory documents such as IND/NDA submissions, MAAs, Product Labeling and promotional materials. Medical leadership on the Product Team and the Clinical/Medical/Regulatory Subteam (CMR), 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. Provide medical support in corporate partner interactions on assigned projects. Accountable, with input from the Safety Officer, for detecting and communicating adverse safety signals to CMR and PLT. Contribute as needed to scientific and medical thinking for other projects. Identify and evaluate external epidemiologic data sources as required. Attend appropriate scientific meetings and stays up to date with relevant scientific literature to maintain expertise. Co-author internal presentations and briefings on product. Co-author external presentations, posters and manuscripts in collaboration with principal investigators on product. Clinical Study Responsibilities Contribute to and advise on the development of clinical research documents including protocols, Informed Consent Forms, Training materials, Study Manuals, Guidelines, etc. Educate investigator and site staff on the medical and scientific aspects of protocols, as assigned. Responsible for medical monitoring including appropriate subject inclusion into protocols, regular review of clinical and laboratory findings in ongoing clinical trials and responding to medical queries from investigators and sites. SAE management, along with Safety operations, including narrative writing (if requested), production of analysis of similar medical event (AOSE) including search terms and written analysis, and writing of company comment Coding review of medical history, adverse events, and concomitant medications. Advise Clinical Managers on the adequacy of clinical and laboratory monitoring schedules in study protocols to achieve trial objectives. Responsible, together with Clinical/Data Managers and Clinical Scientists, for the quality of CRF templates and site tools. Ongoing review of all adverse events for assigned protocols and/or products. Oversee ethical conduct of assigned protocols. Oversee site compliance with eligibility criteria and study-specific procedures. Support clinical operations in detection and communication of adverse trends in any aspect of study conduct, as appropriate to the issue and audience. Detect and communicate adverse trends in any aspect of study conduct. Provide medical and safety input and/or authors sections of the Clinical Study Report. Communicate with CRO staff and sites as needed to understand adverse events. clinical and laboratory findings. If requested by Clinical Managers, accountable to review site monitoring and audit reports and driving necessary corrective actions that pertain to scientific and ethical conduct of trial. Provide medical and safety input and or authors sections of the Clinical Study Report Co-author internal study presentations and briefings. Co-author external study presentations, posters and manuscripts in collaboration with principal investigators. Responsible for leading Data Monitoring Committee (DMC) interactions regarding data, data interpretation, etc on assigned projects. If required, may be responsible for overall DMC management including routine communications. Other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

MD with postgraduate training and 5+ years clinical experience (or an equivalent combination of education and experience) with direct patient care responsibilities. Board-eligible or board-certified in a specialty or relevant subspecialty preferred. 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 law. #J-18808-Ljbffr BioCryst Pharmaceuticals