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Added 2 mins ago
Packaging and Equipment Engineer - On-Site
State Industrial Products
Hebron, OH
The Packaging and Equipment Engineer will lead packaging and equipment development from concept through commercialization, with particular emphasis on chemical compatibility, package…
Added 4 mins ago
Seasonal Sales Associate, UGG
Deckers Retail, LLC
Pleasant Prairie, WI
…products are stocked and available for customers, and merchandize product in accordance with Visual Merchandising standards. You also maintain a clean and well-organized back-stock area and…
Added 9 mins ago
Branch Manager 4 - 82nd & Causey, OR
U.S. Bank National Association
Happy Valley, OR
…employees. This includes providing real-time feedback, fostering development, and ensuring employees are equipped to deliver exceptional customer…
Added 19 mins ago
SA
Shift Lead / Full Time - Franklin, PA
Save A Lot
Franklin, PA
- Full-time
The Shift Lead directs the daily activities of store team members in the absence of the Store Manager and Assistant Store Managers during assigned shifts. The Shift Lead is responsible for…
Added 19 mins ago
Meat Wrapper / PT - Franklin, PA
Save A Lot
Franklin, PA
…Inventory Processes, Meat POG’s, Meat Cutter Resource Manual, Daily Manager Signoff and Meat Cutting…
Added 19 mins ago
Store Clerk / PT - Franklin, PA
Save A Lot
Franklin, PA
The store clerk reports directly to the store manager and indirectly to both the assistant store managers and shift leaders. This position is responsible for duties such as cashiering,…
Added 21 mins ago
WI
(USA) Licensed/Registered Vision Center Manager
Walmart Inc.
FL
- $37 to $50 USD / hour
…oversight, and seasonal execution. Forecasts sales trends and aligns product assortments with member needs, community demographics, and local economic patterns. Monitors competitive pricing…
Added 35 mins ago
M
Starbucks Barista Trainer, Quaker Bridge Mall - Part Time
Macy's
Lawrenceville, NJ
- Part-time
The Barista Trainer supports the Starbucks Manager in running an efficient, professional, safe and profitable Starbucks operation following all company standards.
Added 36 mins ago
E
Product Manager
EarthCam
Upper Saddle River, NJ
- From $90,000 USD / year
EarthCam is seeking an experienced eCommerce Product Manager to take ownership of our digital storefront and lead its continued growth and optimization.
Added 39 mins ago
Associate Project Engineer
USABB ABB Inc.
Houston, TX
Support ongoing DCS system strategies for loading standards across Symphony and 800xA product lines, while assisting engineers and project teams with project design reviews, including…
Added 1 hour ago
Program Manager
RTX
United States
Advanced Products & Solutions (APS) is seeking a Program Manager to manage an international product area within the Radio Frequency Solutions (ARS) Sub-Strategic Business Unit (SSBU). This…
Added 1 hour ago
CR
Sales Manager (Part Time)
Carter's Retail Inc.
Pottstown, PA
- Part-time
As a Part Time Sales Manager, you will be the first face of the brand for growing families. You’ll congratulate new parents and grandparents, the first to introduce our new baby essentials,…
Added 1 hour ago
Marketing Specialist
Drug Hunter
Remote, United States
The Marketing Specialist is a proactive and highly organized marketer who helps execute our product, content, and growth team initiatives. Reporting to the Head of Scientific Growth…
Added 1 hour ago
Channel Marketing Specialist
Drucker Diagnostics
Port Matilda, PA
In this Specialist role, you will work closely with internal commercial, product development, and operational teams, distributors, and external partners to ensure DDx products are presented…
Added 1 hour ago
Channel Marketing Specialist
Drucker Diagnostics
State College, PA
In this Specialist role, you will work closely with internal commercial, product development, and operational teams, distributors, and external partners to ensure DDx products are presented…
Added 1 hour ago
Commercial Credit Analyst I – Middle Market - Great Entry Level Opportunity for those with a degree in Finance or Accounting
TD Bank, N.A.
NY · Ramsey, NJ · Melville, NY
…opportunities to all colleagues. Growth opportunities and skill development are defining features of the colleague experience at TD. Our compensation policies and practices have been…
Added 1 hour ago
Manufacturing Site Supervisor (Memphis)
Spindrift
Remote, United States
Reporting to a Manufacturing Site Manager, the Manufacturing Site Supervisor will be responsible and accountable for executing and helping to improve onsite manufacturing of product to the…
Added 1 hour ago
Sr Project Manager - AI Data Centers
Jacobs
North Miami Beach, FL · Orlando, FL
…infrastructure projects. This role is not focused on software development, enterprise IT programs, application implementation, network operations, cloud transformation, or technology…
Added 1 hour ago
Manufacturing Engineer II (2nd Shift, Onsite)
Collins Aerospace
Seminole, FL
…activities. The ME will report to the Largo Manufacturing Engineering Manager and interface with design, process and other CMC manufacturing engineering, factory operations, and program…
Added 1 hour ago
Senior Manager - Materials, Planning & SIOP (Onsite)
Collins Aerospace
Hollywood, FL
U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract.
Added 1 hour ago
J
Lifecycle Marketing Manager
Jobgether
Remote, United States
- $84,000 to $97,000 USD / year
The Lifecycle Marketing Manager will lead the development and execution of consumer lifecycle marketing strategies designed to strengthen engagement, conversion, and long-term customer…
Added 2 hours ago
Senior Manager, Software Development, Amazon Leo
Amazon Kuiper Manufacturing Enterprises LLC
Sunnyvale, CA
As the manager of this team, you will define the long-term vision for the team and its products as well as hiring and organizing to succeed. The candidate must have expertise with modern…
Added 2 hours ago
Principal Technical Program Manager, Payload SW
Amazon Kuiper Manufacturing Enterprises LLC
Sunnyvale, CA · Redmond, WA
The Leo team is looking for a Principal Technical Program Manager with stronge experience in wir3eless communications/networking and embedded software, project management, and program…
Added 2 hours ago
Partner Manager, Global (US-Based)
Recurly
Austin, TX
Recurly is looking for a Partner Manager to run the day-to-day management of our existing partnerships across payments providers, ISVs, and advisors. This role keeps our partner…
Added 2 hours ago
HS
Account Manager
HAL SOLUTIONS LLC
blue ash, OH
- $850 to $1,250 USD / week
We provide extensive training in all product knowledge, company policies, problem solving, customer service skills, sales strategy and more. This is an upbeat work environment, and we are…

BioCryst Pharmaceuticals, Inc.

Director, Clinical Development Sciences

United States

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Job details

Education: Bachelor’s degree
Posting language: English
Posted: Nov 5, 2026

Original job description

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics. Our global headquarters is in Durham, North Carolina, we have a regional office in Boston, Massachusetts, 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 Director, Clinical Development Sciences, draws on their clinical and scientific knowledge to lead the delivery of high-quality data from multiple sources while supporting the management of global development programs for one or more product candidates, in all study phases. The Director plays a key role in development program design, conduct and oversight, including protocol design, execution, analysis and reporting. The Director will take a leadership role in program and compound level development activities and a leadership role on the multi-disciplinary clinical development team.

The Director will be an active contributor in clinical strategy discussions and in the creation and review of clinical documents to support regulatory submissions. The Director will contribute to program design and oversight of ongoing study conduct and data analysis activities, identify trends and areas for training or process improvements, in support of high-quality data program wide.

ESSENTIAL DUTIES & RESPONSIBILITIES:

Represents Clinical Development Sciences in integrated development teams to ensure high scientific, ethical and regulatory standards and expeditious registration submissions worldwide.
Leads multi-disciplinary clinical development teams to ensure proactive risk identification and management, consistency across development programs, data quality and scientific validity.
Responsible for the content and/or scientific review of medical and scientific elements of clinical research and regulatory documents, including but not limited to protocols, IBs, IND, MAA or NDA modules, PIP/PPSR documents, and clinical study reports.
Serves as subject matter expert for assigned clinical development program(s) and works closely with relevant stakeholders to lead development and implementation of trials and programs, including trial/program design, trial/program-specific data collection tools, data review tasks, and data analysis to ensure quality and consistency across the program.
Provides input and oversight into critical study level documentation for key studies, including the statistical analysis plan.
Is a primary member of the clinical development study team responsible for optimal study execution and collection of data together with clinical operations, data management and statistics, accomplished through training CRAs, selection of laboratory assessments for safety and pharmacodynamics, and providing input into tables, listings and figures to be generated.
Serves as SME for regulatory questions on marketing applications globally and supports study level scientists in responding to regulatory questions on CTAs outside the US.
Establish and maintain effective communication and collaboration with functional area peers, including study teams, data management, biostatistics, regulatory, among others.
Support external dissemination of clinical trial data. This may include leading a product publication committee, or proposing, authoring, or reviewing abstracts, posters, and manuscripts.
Presents to and interacts with investigators and thought leaders. May conduct or be responsible for scientific training (e.g., SIVs, Investigator Meetings, or study data), clinical development and medical advisory boards.
Provides leadership and oversight to clinical development staff, including a team of study level scientists on individual studies within the assigned program.
Responsible for setting goals and staff performance evaluation for direct reports. Ensure that staff have a clear understanding for their career path. Assists with development and implementation of training plans and leadership development.
All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

Bachelor’s degree required. Advanced scientific degree (MD/PhD/PharmD) strongly preferred.
A minimum of 10 years of pharmaceutical development experience, including at least 3 years in a Sponsor role and broad experience in clinical development or an equivalent combination of education and experience.
Expertise in clinical trial and program design, conduct, interpretation of scientific data, GCP, statistical analysis, and management of cross-functional clinical/ regulatory teams.
Experience in Rare Disease drug development is desirable.
Demonstrated track record of scholarship, publication and membership in scholarly societies OR proven track record of successful protocol development, execution, and reporting in industry.
Understanding of pharmaceutical business, worldwide drug development and regulatory process.
Ability to work independently and accountable for managing multiple studies concurrently.
Strong leadership and inter-personal skills, the ability to manage and cultivate relationships, the ability to recommend/make high-level decisions and to communicate effectively on a senior management level and externally.
Ability to clearly communicate information appropriate for the target audience, from individual patients to regulatory agencies, including presentations to FDA and European Medicines Agency (EMA), investigator meetings, and external/key opinion leader (KOL) advisory panels.

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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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More about this job

Skills

Reporting
Data analysis
Clinical research
Documentation
Statistics
Data management
CTAS
Communication skills
Collaboration
Leadership
Google Cloud
Work independently
Circulate information
Presentation skills
Regulatory compliance
Employment law

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