The Biostatistician, Director, will be responsible for one or multiple therapeutic areas to ensure Clinical Development projects are correctly designed, properly analyzed and clearly presented to support new product development, domestic and international regulatory submissions.
Reporting to the Senior Vice President, Clinical Development, this Director will be accountable for the execution of all aspects of biostatistical activities.
The finalist will be a critical team member and should possess a PhD or equivalent greater than 7 years of experience in biostatistics within the pharmaceutical/medical device industry.
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The candidate will be responsible for managing cross-functional clinical stage development projects to ensure on-time and on-budget performance. They will partner with the Project Leader for the projects to assure that the project plans and timing are aligned with both project and corporate strategy. In addition, the candidate will be asked to help manage the more mature drug discovery projects as they transition into development. Clinical development will take place both nationally and internationally. The Project Manager will report to the CSO and work in concert with senior members of the Non-clinical Development, Pharmaceutical Development, Regulatory Affairs, Clinical Development Finance and Commercial teams to deliver the project as planned.
The finalist should possess a BS or equivalent and greater than 10 years of drug discovery and/or development experience.
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The candidate will provide leadership for the GXP compliance and Quality Unit function at Trevena, Inc. Responsible for ensuring the compliance of non-Clinical actives with cGLPs; Pharm Dev with cGMPs; and Clinical Operations with cGCPs. Responsible for growing and enhancing the Quality Systems at Trevena in order to achieve this compliance. Serve as final approval of products, materials, documentation and reports as directed within the defined quality systems. Offer support, guidance and/or resource to all teams where questions arise around GXP compliance activities. Responsible for communication of Quality Systems and GXP compliance actives to appropriate regulatory bodies and heads of quality assurance from external vendors. The Sr. Director/VP of Quality Assurance may not have extensive experience in all three areas (GLP/GMP/GCP), but must have sufficient experience and external vendor management skills to establish Quality Unit support of all GXP functions.
Reporting to the CEO or CFO, the finalist must possess a PhD or equivalent and greater than 10 years of leading a GXP function.
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The Clinical Development Scientist, Associate Director, leads and oversees the scientific planning, analysis, and reporting of clinical trials (Phases I-IV), in compliance with company processes and regulatory requirements.
Works on interdisciplinary teams to develop and execute clinical development strategies to support new product development, domestic and international regulatory submissions.
Reporting to the Senior Vice President, Clinical Development, the finalist should possess a PhD or equivalent and greater than 7 years of experience in clinical development within the pharmaceutical/medical device industry.
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The candidate will serve as the Company’s strategic outsourcing manager, coordinating the evaluation, implementation and management of all Research and Development (R&D) outsourcing. The individual will be responsible for the hands-on management of the Request for Proposal (RFP) preparation process, including development of project specifications, timelines, budgets and payment schedules (unit cost milestones etc.) in collaboration with the functional team. Further, the incumbent will coordinate Clinical Research Organization (CRO)/vendor evaluation and selection activities, oversee third parties to ensure timely execution, and work closely and in concert with Senior Management, Clinical Operations, Project Management, Finance and Contracting in developing and implementing R&D strategy.
The finalist should possess a B.S. degree in Science or other discipline, with 5+ years of hands-on clinical outsourcing and contracts experience working in the pharmaceutical industry and/or with a CRO.
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We believe in our science and in the people that make it possible. As a small company, every employee is critical to our success and we strive to make sure that every voice is heard. We all sit in an open-plan office with no physical barriers to communication and interaction across disciplines and across levels. The company’s goals, challenges and successes are clearly outlined and we work as one team to make the organization successful.
We empower our employees to make their contribution count. Every employee has an opportunity to impact Trevena’s success and to benefit personally from that success as a shareholder of the company.
We work hard but we also have fun. Whether it’s sharing a home-made cake in the break room, running off calories together in Valley Forge park or throwing gutter-balls at Trevena bowling night, there is a strong focus on social as well as scientific interaction.
At Trevena, we have built a great team, who are committed to ground breaking science, and to each other. We involve all key team members in hiring decisions and are delighted that the culture of passion, commitment and fun stays strong as the company continues to grow.
The Trevena site is a custom-built office and laboratory space in King of Prussia, Business Center. The Business Center provides access to a café, a small gym and shower facilities. For the outdoor enthusiast, Valley Forge park is on the doorstep and for shopping/dining, King of Prussia Mall is close by.
In the broader area, there are a multitude of attractive, communities where our employees can base themselves. From the Philadelphia Main Line through to West Chester, towns include Bryn Mawr, Radnor, Villanova, Wayne, Devon, Berwyn, Paoli and Malvern. Even closer to the site, employees live in King of Prussia, Conshohocken, Phoenixville and Audubon. There are many opportunities to base yourself near great schools, restaurants, farmers’ markets etc.
The Trevena region is part of the Greater Philadelphia’s Life Sciences Cluster, an active, vibrant and supportive community working to accelerate the growth of life sciences companies. This region achieved top rankings in the 2009 Milken Report due to a strong blend of established pharma, research infrastructure, world-renowned universities, emerging startups, workforce, and support network for entrepreneurs.
Source: Select Greater Philadelphia
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