Tracy Kane Email and Phone Number
Newton, MA, US
Tracy Kane's Location
Newtonville, Massachusetts, United States, United States
Tracy Kane's Contact Details
Tracy Kane work email
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Tracy Kane personal email
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Tracy Kane phone numbers
About Tracy Kane
I am a program leader/manager executive in the biopharma industry with 22 years of experience. My responsibilities have evolved from conducting pharmacology studies, managing contract research organizations and interpreting data as a Pharm/Tox Core team representative in drug development to leading and managing multi-disciplinary departments and cross-functional teams in R&D and commercial stages as a Program Manager and Program Leader. In recent experiences I have built out the Program Management function from the ground up while also serving as the Program Leader for several programs. I have experience working collaboratively with the executive team and department heads on pipeline expansion planning and resource adjustments when appropriate and program prioritization, scenario planning and pipeline pivots are all familiar territory for me as well. I realize the importance and impact of program management and leadership done well in drug development and have a proven track record of execution on deliverables.Specialties: Proven successful track record in drug development with the approval of a therapeutic from discovery to commercialization, ample experience with regulatory submissions including many INDs, strategic scientific collaboration and strong communication skillset, CRO management and program leadership/management.
Tracy Kane's Current Company Details
Tracy Kane Work Experience Details
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Senior Director, Asset Lead, Isotope StrategyLantheusNewton, Ma, Us
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Senior Director Program ManagementKestrel Therapeutics Feb 2024 - PresentAllston, Ma -
Vice President Program ManagementSpero Therapeutics Aug 2021 - Sep 2023Cambridge, Massachusetts, United StatesResponsible for building out the Program Management function in support of Phase 2 and beyond assets. Directly managed one senior program leader and two program managers. I led two program teams in the anti-infective space.• Participated in several Advisory Boards with KOLs in the infectious disease space aimed at designing Phase 2 and 3 clinical trials.• Tracked key milestones and deliverables required for contractual obligations and incentives across a multi-partner asset with industry and government collaborators.• Collaborated with a task-force sub-team committed to preparing a response package to a clinical hold due to a toxicology study finding mid-trial. Hold was removed.• Supported NDA submission for an oral antibacterial candidate for complicated UTIs. -
Senior Director Of Portfolio And Program ManagementSilicon Therapeutics Jun 2020 - Aug 2021Boston, Massachusetts, United StatesBuilt out the Program Management function and collaborated with the executive team and department heads on expanding and managing the portfolio resources. This included partnering with both program leads and department heads on pulling together a resource plan and prioritizing our programs to align with the hiring plans.• Led team through IND filing and Phase 1 study start up activities through careful coordination of resources and gap analysis planning to de-risk the IND through mentoring of junior program manager.• Assembled a portfolio expansion growth plan working with Department Heads while critically assessing when resources were needed based on key decision points for programs and exploring opportunities for resource shifts based on kill points.• Revised annual budget planning process with improvements to increase efficiency of obtaining this information from the teams.• Conducted portfolio planning (headcount, resources, timelines) for a 10+ program combined portfolio with Roivant including brand new targets.
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Senior Director Program ManagementSynlogic, Inc. Feb 2020 - Jun 2020Cambridge, Massachusetts, United StatesLed and managed an immuno-oncology team from IND submission into entering a Phase 1 trial with a STING agonist for the treatment of advanced and metastatic solid tumors or lymphoma. Managed a program in the IBD space in a collaboration with AbbVie in the research/pre-IND phase. Strategically reviewed Synlogic's portfolio as a member of the Program Strategy and Portfolio Development team and ensuring we resourced appropriately across the developing pipeline.• Led team through IND filing and Phase 1 study start up activities through careful coordination of resources and gap analysis planning to de-risk the IND submission.• Collaborated with CMO, medical monitor and medical oncologist consultant on compiling an amendment to the protocol based on site and PI feedback and safety reviews of patients.• Worked with Business Development and Competitive Intelligence to ensure Synlogic was keeping potential partners up to speed on the program while keeping a pulse on the competitive landscape.• Actively planned an advisory board for participation from investigators and KOLs and led the effort to develop the agenda and content for discussion. -
Director, Program LeaderSynlogic, Inc. Apr 2019 - Jun 2020Cambridge, Ma
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Director Program ManagementSynlogic, Inc. Feb 2018 - Apr 2019Cambridge, Ma
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Director, Program ManagementRetrophin Jan 2017 - Dec 2017Cambridge, MaLed development teams at pre-IND and commercial/post-marketing stages.• Coordinated with Quality, Regulatory and Pharmacovigilance teams and European consultants/vendors on completion of European inspections for marketed products.• Managed cross-functional efforts to kick-off a registry Phase 4 trial and a Phase 3 proof-of-concept trial for a label change.• Participated in trial design and coordinated with CRO to execute upon the study.• Supported development of ex-US strategy for marketed products
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Director, Nonclinical Project ManagementRetrophin Jan 2016 - Dec 2016Cambridge, Ma
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Head, Preclinical Project ManagementRetrophin May 2014 - Dec 2015Cambridge, Ma
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Senior Project ManagerRetrophin Mar 2014 - May 2014Cambridge, Ma
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Program ManagerIronwood Pharmaceuticals Jun 2013 - Jan 2014Cambridge, MaProgram manager for a small molecule development team. Organized the activities, timelines and deliverables of the 30-person team. Compiled an agenda for team meetings, collaborated on smaller action item-driven focus teams, and tracked external expenses, headcount, functional activities and timelines. • Developed and updated the company’s research and development operating plan by tracking external spend, headcount and timeline for a multi-million dollar project. Participated in and supported the quarterly and annual planning, helping to drive the corporate goals. • Proactively identified the critical risks for the program and developed an appropriate mitigation strategy enabling the program to move forward toward success without delay.• Collaborated with smaller focus teams charged to identify the mechanism of action for the molecule and establish a target product profile helping to expedite team decision making.• Streamlined data tracking processes with the maintenance of a SharePoint team site for central access to all team-related documents, spreadsheets and data. • Communicated team progress with an external partner on a bi-weekly basis. Built trust and credibility resulting in a strong informed partnership. -
Preclinical Development Study Manager I/IiIronwood Pharmaceuticals Jan 2007 - Jan 2014Cambridge, MaToxicologist on Preclinical Development team responsible for leading the planning, protocol development, coordination, and execution of contracted toxicology work. Responsible for strategic toxicology planning on discovery and development teams and assumed role of primary author for nonclinical sections in regulatory submissions. • Successfully negotiated numerous contracts/study outlines and start dates with contract research organizations and established mutually beneficial relationships with industry CROs.• Efficiently developed toxicology study protocols in compliance with applicable GLP, OECD, EMA and MHLW regulations/requirements and FDA, ICH guidances. • Conducted dose range-finding studies, general toxicology, genetic toxicology, safety pharmacology, carcinogenicity, reproductive toxicology, juvenile toxicology, specialty toxicology and mechanistic studies from IND to NDA.• Partnered with program management and scientific program leaders to identify, communicate and address preclinical challenges to the discovery and development programs. • Trouble-shot challenges (impurity levels, juvenile toxicology concerns and post-marketing requirements) as peptide was being developed to continue to move forward on critical path.• Authored, reviewed and updated nonclinical sections in all regulatory submissions. Reviewed entire compilation of regulatory submissions and collaborated with cross-functional groups to assemble sections for submission. This included numerous INDs, CTAs, briefing books for FDA meetings, Annual Reports, DSUR and PSURs, Investigational Brochures and one NDA.
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Senior Associate Scientist I Preclinical DevelopmentIronwood Pharmaceuticals Mar 2005 - Dec 2006Cambridge, MaToxicologist on Preclinical Development team responsible for leading the planning, protocol development, coordination, and execution of contracted toxicology work to support therapeutic programs. Responsible for strategic toxicology planning on discovery and development teams and assumed role of primary author for nonclinical sections in regulatory submissions.
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Senior Associate Scientist I In Vivo PharmacologyIronwood Pharmaceuticals May 2003 - Mar 2005Cambridge, MaKey member of the Pharmacology team that established and conducted in vivo models for discovery programs. Modified existing models to create Ironwood specific animal models and performed assays on a daily basis to assess the efficacy of molecules• Executed pharmacokinetic studies to provide data for determining the bioavailability of molecules for preclinical candidates.• Managed all in vivo experimentation to support discovery programs and served as point person for communication between integral functional teams.• Presented critical pharmacology data on a regular basis to team members and created presentations that were incorporated into due diligence packages for partner discussions.• Authored several IND pharmacology reports documenting the in vivo experimentation that supported the efficacy of the molecule.• Partnered with IT programmers to develop and customize IT systems which streamlined data processing and interpretation.• Trained fellow team members on new information systems and encouraged the active implementation of the systems, improving the overall efficiency of the team.
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Associate Scientist Ii In Vivo PharmacologyIronwood Pharmaceuticals Jan 2003 - May 2003Cambridge, MaKey member of the Pharmacology team that established and conducted in vivo models for discovery programs.
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Associate Scientist I High-Throughput ScreeningIronwood Pharmaceuticals Sep 2001 - May 2003Cambridge, MaKey member of High-Throughput and Technological Processing team that screened chemical libraries for primary hits in support of discovery programs.• Screened over 100,000 compounds through six major screens employing the use of various robotics and using programs designed for data management.• Developed new information management systems with an IT support team to track primary data and expedite hit to lead development time.• Lead the transition of reformatting the compound libraries to 384 well plates from 96 and assisted in the purchase of robotics to increase the rate at which a screen could be completed.• Managed the arrival of compound libraries at Ironwood and ensured the compounds were prepared, replicated, and stored for use in the primary screens
Tracy Kane Skills
Drug Development
Toxicology
Protocol
Regulatory Submissions
Pharmaceutical Industry
Biotechnology
Life Sciences
Program Management
Drug Discovery
Pharmacology
Clinical Development
Fda
Team Leadership
Presentation Development
Operating Budgets
Cro
Cross Functional Team Leadership
Drug Safety
Glp
Cro Management
Team Management
Strategic Communications
Scientific Writing
Highly Detail Oriented
Multi Tasking
Collaborative Problem Solving
Financial Modeling
Timeline Development
Risk Management
Risk Assessment
Troubleshooting
Contract Management
Glps
Oecd
Ich Guidelines
Program Facilitation
Tracy Kane Education Details
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Harvard University Extension School3.93 Overall Gpa -
Overall 3.4 Gpa
Frequently Asked Questions about Tracy Kane
What company does Tracy Kane work for?
Tracy Kane works for Lantheus
What is Tracy Kane's role at the current company?
Tracy Kane's current role is Senior Director, Asset Lead, Isotope Strategy.
What is Tracy Kane's email address?
Tracy Kane's email address is tk****@****rma.com
What is Tracy Kane's direct phone number?
Tracy Kane's direct phone number is +176026*****
What schools did Tracy Kane attend?
Tracy Kane attended Harvard University Extension School, University Of Rochester.
What are some of Tracy Kane's interests?
Tracy Kane has interest in Swimming, Hiking, Traveling, Skiing.
What skills is Tracy Kane known for?
Tracy Kane has skills like Drug Development, Toxicology, Protocol, Regulatory Submissions, Pharmaceutical Industry, Biotechnology, Life Sciences, Program Management, Drug Discovery, Pharmacology, Clinical Development, Fda.
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3hartfordschools.org, edadvance.org, torrington.org -
Tracy Kane
Nashville Metropolitan Area5gmail.com, gmail.com, leankit.com, dodsonparker.com, endeavorbusinessmedia.com4 +161549XXXXX
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Tracy Kane
Wilmington, Nc
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