Dan Farina Email & Phone Number

Greater Philadelphia Area, Pa, Us

Junto HLS focuses exclusively on Life Sciences recruiting. We partner with pharmaceutical and biotech companies ranging from 50 to 50,000 employees; successfully recruiting top talent across the spectrum from Discovery through Development and Commercialization.We have a built a strong network based on integrity, trust and results. Our efficient and effective approach will be a competitive advantage for you and your business.Our Mission: Recruit top talent to meet our clients'​ business objectives and the medical needs they address.www.JuntoHLS.com

Newtown Square, Pa, Us

Dublin 2, Ie

- Major Pharmaceutical Company: Site / Study Management (Clinical Operations) Organization and Process Improvement – Performed an as-is assessment and determined key issues and recommendations. . Improved key processes identified in the assessment. Led composition of the Future Model. Facilitated the globalization of clinical operations/services organizations. Led role description creation and RACI development for 2700 FTEs - CRAs / Site Managers, Study Managers, Global Trial Leads, Medical Monitors, Clinical Trial Associates and Clinical Research Scientists.- Major Pharmaceutical Company: Data Governance – Led the design and deployment of a process for the creation of both clinical data standards and study eCRFs/ associated components which met in-place cycle times/ milestones. Managed creation (design to go-live) of a Library Management System to search, store, and utilize clinical data standards. Oversaw the definition of operating model details. Trained large cross functional groups and provided content and strategic input to the long-term training solution.- Major Pharmaceutical Company: CDISC / SDTM Data Migration Factory (Lead) Created a reusable, standardized process for the mapping, migration, and validation of study data to the SDTM format. Defined key processes (i.e. programming, verification, change control and mapping creation and approval), and met submission times.- Mid-Tier Pharmaceutical Company: Clinical IT Roadmap - Provided IT and business functions with both a 3 year initiative roadmap and capital/expense estimates to support FY10 budget requests. Cross functional stakeholder interviews elucidated key business needs. Needs were prioritized based on Strategic Imperatives as defined by Sr. Leadership. Created project charters reflecting business needs, scope, key assumptions, and qualitative value.

New Brunswick, Nj, Us

- J&J Company: Regulatory Strategy and Operations – Led the filing of the first electronic IND in eCTD format at Therakos. Integrally involved in development program/ protocol design. Authored CMC sections and project managed CMC timelines. Collaborated with Toxicologist to draft and finalize toxicology sections. Compiled/generated the submission. Regulatory Lead on 2 study teams.

Malvern, Pa, Us

• Co-monitoring of clinical sites and in-house site point of contact• Ensure contract CRAs completing required tasks/ drive query resolution• Managed investigator grant payment (Saved $50K by finding CRA mistakes/ site overpayments)

Cambridge, Cambridgeshire, Gb

- AstraZeneca ($2.5 B Megabrand): Regulatory Strategy – -Regulatory lead on 2 business critical Ph. III submission studies - Regulatory lead on US & Global Investigator Sponsored Study Teams (>100 protocols reviewed)- Prepared Key Messages doc. for global submissions (Leveraged TPCs, protocols, & guidance)- Supported the preparation for a pre-sNDA meeting with the FDA-Managed and prepared an FDA submission regarding the discontinuation of a risk management program after consultation with cross-functional stakeholders

Bs, Pharmaceutical Product Development (Business/Science/Industry Specific)

Education record