COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama. Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

JOB SUMMARY:

The Medical Director, Clinical Development plays a key role at all stages of clinical development for product programs from the drug discovery stage through product registrations world-wide. Oversees ongoing and planned product trials and the exploration of novel indications. Provides clinical leadership to cross functional project teams on clinical development strategies, clinical study outlines and data interpretation of study results.  #LI-Remote

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 input and or author sections of regulatory documents such as IND/NDA submissions, MAAs, Product Labeling and promotional materials.
• Act as medical leadership on trial and program teams as assigned. May be assigned to provide representation to Product Leadership team (PLT), leadership team and BOD interactions on the project.
• Act as 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, together with Safety Officer, for detecting and communicating adverse safety signals to CST and PLT.
• 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.
• 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.

EXPERIENCE & QUALIFICATIONS:

• MD from a US accredited institution with postgraduate training and at least 2-5 years’ clinical experience with direct patient care responsibilities.
• Demonstrated drug development experience within the biotech/pharmaceutical industry, including medical monitoring, 2-5 years preferred.
• Experience with anticipating and solving the practical issues encountered in execution of clinical trials.
• Strong quantitative skills, including solid familiarity with statistical and epidemiological concepts (record of publication in the field is desirable).
• Understanding of the clinical-regulatory-commercial development process and its intricacies.
• Ability to manage multiple projects and maintain timelines and to work in cross-functional teams.
• Ability to work in cross-functional teams.
• Deep familiarity with ICH and GCP guidelines.
• Excellent written and oral communication, interpersonal, and organizational skills.

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.