Job Title: Vice President, Research
Department: Research and Development
Reports to: Senior VP, Research and Development
Location: San Diego, CA
The Vice President, Research will provide scientific leadership to discovery, preclinical, and clinical development programs. This position will be responsible for overseeing development and innovation efforts for Retrophin. The VP, Research will work with other teams within the company to strategize and bring new products from the R&D side to market or implementation within Retrophin.
Responsible for establishing company’s nonclinical/discovery research strategy and provide scientific input into company’s research and development programs in support of the overall corporate strategy.
Accountable for the design, execution, analysis and interpretation of nonclinical development and clinical pharmacology studies and data, to enable creative and timely regulatory submissions globally that satisfy regulatory expectations and requirements.
Ensure the integration of nonclinical and early clinical findings with planned clinical programs; secure cross functional alignment and transparent discussion of opportunities and risks, with clear plans to further investigate, optimize, and track throughout development.
Provide support to Technical Operations (Manufacturing/CMC) to problem solve real-time issues associated with commercialized products.
Provide guidance on potential business development opportunities, participate in ad hoc due diligence activities and provide expertise from a nonclinical development and clinical pharmacology perspective to Corporate Development.
Effectively and transparently manage multiple, at times conflicting priorities, and proactively seek creative yet viable solutions to resolve such conflicts.
Appropriately balance the internal infrastructure and capabilities versus outsourcing, while ensuring systems are in place to safeguard a GxP compliant environment.
Maintain up to date knowledge of regulatory agency nonclinical/clinical pharmacology and toxicology regulations/guidelines, and maintain a command of relevant scientific literature and evaluate implications for internal projects.
Represent nonclinical development and clinical pharmacology as a subject matter expert and thought leader, develop and maintain relationships with KOLs, clinical researchers and academicians.
Develop and administer budgets, resource plans and performance objectives for a functional area staff.
Responsible for providing strategic input for company’s mid- and long-term goals from the scientific standpoint.
Responsible for the collaboration of the company’s Scientific Advisory Board.
Specific responsibility in directing the discovery, preclinical and Translational Science Programs of the Company
Identify, evaluate novel preclinical drug development opportunities and candidates and progressing them into IND-enabling studies and into human PoC clinical trials.
Oversee efforts to seek partnerships/collaborations with academic institutions and/or with other pharmaceutical companies to support the Translational Sciences platform development.
Oversee the design and execution of in vivo studies, standardization of in vivo models, and development and characterization of new models to support project advancement as necessary
Generate key translational data using to guide indication selection and identify target patient populations for programs.
Participate in regulatory submission documents, internal documents preparation and scientific publication.
Establishing and managing key clinical and academic collaborations to facilitate access to clinical samples to support the Translational Sciences platform development.
PhD or MD in a drug development-related disciple with 15+ years of experience in the pharmaceutical or biotechnology industry, with 10+ years of direct experience in nonclinical development. Equivalent combination of education and applicable job experience may be considered.
A broad understanding of drug development as evidenced by a track record of significant contributions to successful patents, INDs, Regulatory Agency interactions, NDAs, drug approvals, in-licensing deals and peer reviewed publications. Global experience is strongly desired.
Proven ability to build and lead an excellent nonclinical development, ideally with extensive outsourcing components and including organizational design and the recruitment, development and retention of first-rate personnel.
Proven creativity in balancing project needs and department resources (Demand vs. Supply) in a unique, fit-for purpose model.
Experience building and managing collaborations with scientists, contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations.
Proven track record of being a strategic thinker and a tactical implementer.
Consistent publication record in peer reviewed journals across therapeutic areas and patent record.
Strong familiarity with validation of drug targets and the exploratory drug development process.
Overall business understanding including experience in business development and licensing contracts, strong leadership skills and the ability to drive results.
Fiscal responsibility and the ability to facilitate commercial return from research and development investments.
Strong ability to multi-task and to handle multiple programs and portfolios in drug discovery and development.
Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
Ability to travel 10% domestic and internationally.
Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer