Product Development Director
- Ph.D., in immunology, inflammation, nutrition, genetics, bioinformatics, translational medicine or related field.
- Experience in managing a laboratory and staff.
- Experience in bioinformatics and predictive computational and mathematical modeling.
- Experience in IND package submissions to the FDA.
- Experience in managing GRAS dossiers and panels.
- Experience in GLP toxicity and safety studies and PK/PD studies.
- Demonstrated expertise in diabetes and/or inflammatory bowel disease.
- Demonstrated expertise in flow cytometry and cell culture assays.
- Demonstrated record of publication in high impact journals peer-reviewed journals.
- Demonstrated expertise in mouse, rat, or pig experimentation.
- Excellent organizational, time management, and multitasking skills.
- Capable of working in a team environment with a strong inclination for transdisciplinary team science and with an emphasis on translational medicine.
- Creativity, independence, and self-motivation, with good communication skills. Responsibilities: Desired skills:
- Serve as a product developer
- Develop product, product pipelines for the pharmaceutical, nutritional and informations divisions of BTI
- Develop infrastructure for scientific support behind BTI products
- Lead and develop and help implement a BTI Outreach plan to Pharma, VC and Angels
- Establish and maintain external network with partner communities and collaborative alliances
- Understand and develop partnership and other types of agreements
- Represent BTI at conferences, seminars, workshops, and venture capital, media outlets, and Biotech conferences
- Protect BTI intellectual properties and products by help write patent applications
- Contribute to the submission of research proposals to funding agencies, if necessary as PI as instructed by the CEO or other senior officers.
- Identify/Propose funding opportunities that are programmatically aligned with BTI.
- Manage acquisition of IND-enabling efficacy, safety, toxicity, PK/PD data under GLP by interfacing with subcontractors and consultants in CMC/API, IND-enabling GLP Tox and clinical.
Serve as an internal innovator
- Evaluate emerging scientific trends for sustainability and maturity to drive the development of new products, solutions and initiatives
- Maintain and extend development of in silico mathematical model service core
- Assist in the creative drive of BTI through branding, interfacing with consumers and customers via social media and strategic website maintenance.
- Develop innovative marketing plans and strategies to promote BTI’s intellectual property and product sales in collaboration with the CEO and management team.
- Develop novel methods for in silico human clinical trials
Serve as an internal technical expert
- Direct and engage in day-to-day operations for preclinical efficacy and safety development of novel drugs for chronic, infectious and immune-mediated diseases
- Provide in-depth scientific evaluation of projects to senior BTI leaders.
- Contribute to IP conscious publication of original research results in peer-reviewed journals.
- Use internal data to define follow-up studies that are strategically focused and therapeutically aligned.
- Actively collaborate in projects related to in silico screening of compound databases for drug discovery
- Train, mentor and supervise experimental laboratory staff with techniques and experimental procedures.
- Keep detailed and accurate computer records and maintain/update data in computer-based applications/databases.
- Supervise optimization and design of standard operating procedures for animal facilities and laboratories.
- Provides knowledge for development and maintenance of regulatory compliance and animal care and use guidelines; Food and Drug Administration (FDA), United States Department of Agriculture (USDA), Institutional Animal Care and Use Committee (IACUC), Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC).
- Becomes a member of the BTI IACUC and Chairs it if appointed by the Institutional Official/CEO
- Knowledge or experience in therapeutic development for chronic inflammation and autoimmune disorders.
- Expertise in basic, translational and clinical research.
- Expertise in marketing, branding and pr.
- SBIR/STTR and R01 Grant, and IDIQ contract writing experience.
- Experience in pre- and post-award contract and grant management.
- Previous expertise in mouse models of inflammatory bowel disease and diabetes.
- Expertise in patent development.
- Computational/bioinformatics skills and expertise.
- Demonstrated experience in creating and maintaining a website.
- Knowledge of genomics in multiple disease areas (oncology and immunology preferred)
- Proven track record of leading the development and deployment of bioinformatics systems and applications that are an integral part of drug development and translational medicine.
- Demonstrated ability to establishing effective collaborative relationships with cross functional scientific and clinical teams.
- Strong communication and organizational skills.
- Experience with statistical and pharmacometric methods for data mining.
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