This candidate will provide leadership for all aspects of Trevena drug substance and drug product analytical development. Responsible for method development activities, impurities assessments, specification proposals, and stability/reference standard programs, from drug candidate nomination through commercialization. Will partner with Pharmaceutical Development and compound teams to develop appropriate analytical strategy and plans. Responsible for execution of analytical activities predominantly through external relationships. Will offer analytical development support and guidance to all teams when needed. Responsible for communication of Analytical Sciences activities to appropriate regulatory bodies.
Reporting to the VP, Pharmaceutical Development, the candidate should have a proven track record of successful analytical development from discovery through commercialization. In addition, the Candidate should have a thorough knowledge of analytical cGMPs, ICH guidelines and regulatory requirements. Should have a proven track record supporting IND and NDA filings (modules 2 and 3) and experience with European filing requirements.
The finalist should possess a MS/PhD in Analytical Chemistry or related field and 8 – 10 years of pharmaceutical, analytical sciences experience.
Submit your resume for consideration for this role to email@example.com
This candidate will be responsible for managing legal matters affecting the Company including: (i) having primary responsibility for the Company’s contracting process, (ii) providing a variety of general corporate and commercial legal advice and services directly or through liaison with outside counsel, (iii) coordinating legal matters handled by outside counsel, (iv) assisting in the development and oversight of the Company’s compliance programs, and (v) anticipating and guarding against legal risks facing the Company.
Reporting to the SVP, General Counsel & Secretary, this Associate Director will provide counsel and legal support to various departments including Clinical Research and Discovery Research, manufacturing, Commercial and Business Development.
The finalist will require 5-8 years of general corporate legal experience as an attorney in a law firm, corporation or both. In addition, the finalist will require a J.D. from an accredited law school and experience in the pharmaceutical or biotechnology industry, preferably in an in-house capacity.
Submit your resume for consideration for this role to firstname.lastname@example.org
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.
Submit your resume for consideration for this role to email@example.com
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.
Submit your resume for consideration for this role to firstname.lastname@example.org
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
Copyright © Trevena, Inc.