Director, Publications at Vertex Pharmaceuticals
Greater Boston Area
Director, Publications at Vertex Pharmaceuticals
Greater Boston Area
● Medical communication leader with demonstrated experience with generation, review and approval of publications, abstracts and conference presentations
● Project manager with a strong knowledge of drug development processes, including preclinical, manufacturing, clinical, regulatory activities from research through NDA/BLA submissions, post-launch development, marketing and sales.
● Ph.D. scientist with background in infectious diseases and oncology, drug and vaccine development
● Effective communicator with excellent influencing, negotiating and conflict resolution skills; able to work in a complex matrix management environment and to develop and cultivate excellent working relationships with internal stakeholders, external partners and key opinion leaders
● Multilingual: Fluent in French, good understanding of Spanish
● Publication Planning
● Medical, Scientific and Regulatory writing
● Project management
● Virology
(Public Company; 501-1000 employees; VRTX; Pharmaceuticals industry)
October 2008 — Present (10 months)
(Public Company; 201-500 employees; IDIX; Pharmaceuticals industry)
November 2006 — October 2008 (2 years)
● Defined and implemented strategic planning of all medical information dissemination throughout the product lifecycle
● Supervised management and timely execution of the Global Medical Affairs publication strategy and scientific meetings plan by collaborating with investigators to coordinate development, review and approval of scientific, clinical and marketing documents by Idenix and its alliance partner Novartis
● Served as primary writer for pre-clinical and clinical abstracts, posters, manuscripts, slide-sets, medical letters, and other clinical, scientific and commercial communications in collaboration with internal and external authors.
● Coordinated closely with cross functional team to ensure consistent messages are delivered
● Supported Medical Affairs and Global Marketing by providing editorial and scientific review of documents prepared by other medical writers in English, French and Spanish
(Privately Held; 51-200 employees; Biotechnology industry)
July 2005 — August 2006 (1 year 2 months)
● Developed strategy for selection of methods to characterize complex biologics according to ICH guidelines in preparation for BLA filing and commercial launch of Therion’s lead cancer immunotherapy
● Led a group of five scientists and research associates responsible for all cellular and virological aspects of product characterization at pre-clinical and clinical phases of development, method development, validation and transfer to QC group.
● Led the company AIDS vaccine clinical program, organized distribution of products to clinical facilities, participated in drug safety weekly calls with clinical trial’s Principal Investigator and clinicians
● Responsible for managing external collaborations and interactions with contractors
(Privately Held; 51-200 employees; Biotechnology industry)
January 1999 — July 2005 (6 years 7 months)
● Led the company HIV vaccine multi-site, multi-million dollar, 5-year government grant program involving collaborators at research and clinical institutions by coordinating writing of NIH grant and contract proposals, budgeting and reporting to company’s senior management and NIAID grant coordinator
● Provided scientific and technical guidance on all AIDS-related projects
● Represented the company during clinical protocol development and initiation of two AIDS vaccines clinical trials sponsored by NIAID
● Participated in preparation of regulatory documents (IND, IB)
● Provided regular performance feedback, development and coaching to two research associates
(Educational Institution; 501-1000 employees; Research industry)
April 1994 — December 1998 (4 years 9 months)
● Studied the transactivation function of the virion-associated proteins Vpr and Vpx from various primate lentiviruses and the role of coreceptors in HIV-1 and HIV-2 infection using in vitro methods: construction of virus chimera, transfection, viral infection of cell lines and human PBMCs, detection of viral replication by RT assay and ELISA
● Worked and helped in training of two Ph.D. students under BL3 conditions
Post-doc , Virology , 1994 — 1998
Ph.D. , Virology, Molecular Biology , 1989 — 1994
M.S. (DEA) , Microbiology, Molecular Biology , 1988 — 1990
B.S. (Maitrise) , Molecular Biology , 1986 — 1988
B.T.S. , Biochemistry , 1984 — 1986