Colleen Mullen Email and Phone Number

Selected Contracts:-Medical /scientific writing and editing for Fortune 500 biotechnology companies, medical device companies and start-ups.- Peer-reviewed manuscripts, clinical trial reports, case studies, conference materials, training programs, white papers, corporate communications- Regulatory writing includes ICF, IDE, CE mark, IRB, feasibility studies, clinical protocols for medical diagnostic devices, mobile medical applications, mobile ehealth devices- Pre-clinical development strategic planning inclusive of CMO, CRO assessment, CMC validity and alignment.

Director, Patient Narrative FranchiseSelected accomplishments:• Program management of multiple projects supporting >10 regulatory submissions and safety updates• Directs and manages team of medical writers, QC specialists, technical editors and medical reviewers (MD’s) for the narrative franchise• Lead writer, development of SOPs, guidance and client facing materials for the narrative franchise• Business development supporting growth of narrative franchise

Selected accomplishments• Nonclinical writing supporting IND filings of novel oncology therapeutics including cell based therapies• Protocol and protocol amendment development, writing, management of timelines for multiple small molecules in oncology space• CSR development, writing, management of process for small molecules in oncology space.• Team leader, program management for narrative process and development supporting NDA for small molecule in oncology space• Supported multiple successful submissions (FDA, cHA)• Manuscript preparation and editing, oncology and mobile health in MS

Analyzed mental health outcomes for patients using psychiatric emergency services in the Cambridge/Somerville area. Facilitated and coordinated with key stakeholders to increase public safety and created initiatives to support emergency services.

Vice President and Program Executive, Biologics Selected accomplishments:• Designed, implemented comprehensive research to development program in support of variant activated protein C program (VAPC) and devised strategic plan for pre-clinical and Phase I/II activities.• Program Management inclusive of identification of manufacturing partner, analytical services partner, legal partner, PK/toxicology consultants and regulatory affairs consultants; facilitation of all partners relationships and milestone goals to support Pre-IND activities for VAPC • Medical writing in support of pre-clinical and clinical activities along with grant funding activities. • Comprehensive review of external first generation program from EMEA, FDA filings, post BLA and clinical development literature; implemented pre-clinical strategic pathway that avoided potential liability with competitors’ footprint.• Business development, extension of intellectual property portfolio and commercialization strategic plan for external partnership opportunities. • Successful transition to development ahead of schedule resulting in Round 2 series investment.

Vice President Pre-Clinical Development • Pipeline development plans for two Alzheimer related proteins and designed R&D Phase I strategic plans for AD receptor program. Successful Round 1 series investment.