Proclinical is currently recruiting for a Medical Director with a pharmaceutical company located in Redwood City, CA.
- Participate in the development of Global Medical Affairs Plans and outline strategic approaches for generating required evidence and research output necessary to the plan.
- Contribute to develop and execution of the MAR medical strategy and activities to demonstrate the value of medicines
- Research activities will focus on the broad areas of pharmacoepidemiology and will include retrospective database analyses, prospective cohort studies, PROs and real world research
- Create or co-develop study concept documents, protocols, analysis plans, and final study reports, as well as draft manuscripts for studies which include relevant outcomes
- Work cross functionally to assess, evaluate and select which data sources, cohorts, registries and collaborators represent the best partners to achieve the strategic objectives and data generation plans
- Collaborate with colleagues in multiple other functional areas, including HEOR, Therapeutic Area Medical Directors, Commercial Strategy and Clinical Development
- Provide high quality technical and methodological support to cross-functional teams to effectively use clinical, and humanistic data to optimize treatment practice and improve patient outcomes throughout the lifecycle of our medicines
- Contribute assessing data gap and to provide input on clinical and PRO endpoints with Phase II/III/IV clinical trials in partnership with Medical Affairs, Clinical Development and Commercial
- Develop scientific communications (e.g., manuscripts, scientific forum presentations, slide decks) to build the peer reviewed published scientific evidence base
- Maintain and continue to enhance knowledge of technical and methodological advances and trends to ensure best approaches are used in studies and evaluations
- Engage key clinical and methodological experts and facilitate the building of relationships via collaboration on various projects. Provide methodological support at advisory boards, regional educational programs, conferences and other external meetings
- Adhere to all applicable pharmaceutical codes, Office of Inspector General (OIG) guidelines, and company policies
- Exhibit company's core values: integrity, teamwork, accountability, excellence, and inclusion
Skills and Requirements:
- Deep knowledge and prior working experience in fields of company's areas of interest, especially RWD and PRO in oncology and/or liver disease therapeutic areas
- Advanced scientific degree (Ph.D., MD, Pharm.D. or equivalent) ideally in Epidemiology, Public Health, Outcomes Research, or Biostatistics, with a minimum of 6+ years of experience in pharmaceutical industry, and 4+years of OR
- Strong methodological knowledge including retrospective and prospective study design and analysis, database assessment (including quality assurance metrics to ensure validity and robustness of the data elements) and analysis, advanced statistical methods needed for observational data, real world studies and/ or PRO development. Proven track record as demonstrated by publications in peer-review journals
- Excellent project management and organizational skills, including management of multiple priorities and resources
- Proven track record of executing clearly defined goals and objectives
- Affinity for a collaborative, team-oriented environment and approach; ability to network and partner with internal and external stakeholders, including medical thought-leaders, and academic institutions
- Aptitude for, and experience in, scientific dissemination of study outputs focused on internal and external stakeholders
- A comprehensive understanding of global healthcare systems is preferred
- Excellent oral and written communication skills and interpersonal skills
- Knowledge of Microsoft Office suite (Word, PowerPoint, Excel, and Outlook) is required
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.