Director, Bioanalytical & PKPD Strategy

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 uson LinkedIn and Instagram.

JOB SUMMARY:

The successful candidate will have an intimate understanding of drug development from the perspective of bioanalytical method development, biomarker strategies, pharmacology, and the development of data sets to fully characterize the PK/PD relationship of both small and large molecules in development. The incumbent will be responsible for directing all bioanalytical and biomarker method development and validation for both small and large molecules as well as the development of biomarker strategies within nonclinical and clinical studies. Additionally, the incumbent will be responsible for the characterization of the PK/PD relationship within discovery and development programs utilizing animal models, and in vitro methods, as appropriate. With a dynamic personality the individual works well as a local or remote team member and is able to work independently as well as in a close and collaborative team environment, traveling to face to face team meetings as required. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Coordinate the development and validation of appropriate methods for protein therapeutics or endogenous analytes in support of new or ongoing projects in applicable biological matrices.
• Participate in the selection of appropriate biomarkers and lead the development of appropriate methods for the analysis within discovery, nonclinical, and clinical studies.
• Direct and coordinate the analysis of drug substance or endogenous analytes in support of ongoing clinical and nonclinical studies. This work is achieved primarily through working with outside vendors, but also through interactions with colleagues in Discovery Biology
• Devise strategies for the elucidation of PK/PD relationship of therapeutics in development, including but not limited to pharmacologically relevant animal models of disease, and other in vitro methodologies in order to guide dose setting and computational modeling.
• Evaluate and select appropriate vendors, as applicable. Maintain relationships with existing vendors and coordinate contracted analyses and data communications.
• Responsible for components of nonclinical studies to evaluate the disposition of NMEs in both nonclinical and clinical trials
• Working closely with nonclinical and clinical team members on the authoring of INDs, NDAs, BLAs and other regulatory submissions with overall responsible for the bioanalytical content.
• Works closely with DMPK, Toxicology, Clinical Pharmacology, Clinical Science, Clinical Operations, and Discovery Biology scientists to provide support to drug discovery and development teams.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• A PhD in a biological science is preferable or an equivalent combination of education and experience.
• At least 7 years of experience in a regulated drug development environment, with at least 5 years of experience working on development programs with visibility to health authorities in the approval of new therapeutics.
• Proficiency in the development and validation of bioanalytical assays with a special focus on large molecular entities and biomarker methods.
• Strong interpersonal skills and ability to work effectively in a remote team environment.
• Extensive knowledge of regulatory guidelines regarding bioanalysis.
• An expert understanding of GLP regulations and regulatory expectations of bioanalytical reporting.
• Proven track-record of successful progress of protein therapeutic candidates through the discovery and development process.
• Strong leadership and interpersonal skills, able to problem-solve using personal judgment and work independently.
• Must be an excellent time manager with an ability to meet deadlines, accomplish work in order of priority, and adjust to new situations.
• Excellent English verbal and written communication skills.
• Willingness to travel to face-to-face team meetings in Durham, NC, Birmingham, AL, and regulatory interactions as necessary.
• Detail-oriented with meticulous oversight, coordination, tracking abilities, and long-range planning.

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.