Responsible for proactively executing on regulatory affairs activities both within and outside the U.S. including: (i) global regulatory interactions, (ii) project-level regulatory interpretation and guidance, (iii) regulatory activities handled by vendors and/or CRO’s, and (iv) helping to anticipate and guard against regulatory risks facing the Company.
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The Senior Vice President, Commercial will report directly to Trevena’s President and Chief Executive Officer, Maxine Gowen, Ph.D. The successful candidate will be responsible for leading the development and execution of the Company’s commercialization strategy as Trevena advances its product candidates through clinical development, regulatory approval and launch. He/She will provide commercial input to R&D activities so a compelling business case can be built for each of the pipeline products. Functional responsibility will include overall commercial strategy, new product planning, and product brand strategy (product positioning, pricing, branding and launch). The SVP, Commercial will interact and collaborate effectively with peers inside of the company, Key Opinion Leaders, payers, business partners and investors. This position requires an exceptional individual who excels in leading cross-functional teams.
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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.
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Clinical Pharmacokineticist (PK), Associate Director The Clinical PK, Associate Director, is responsible for PK and PK/PD related support such as study design, planning and execution, data evaluation, analysis, and report preparation. Specifically, providing PK portions of protocols synopses and protocols, dataset preparation and data merging for PK analysis, non-compartmental and/or compartmental PK analyses, simple population PK analysis, preparation of PK and PK/PD reports, publications, and presentation of PK data in regulatory documents and meetings. Works on interdisciplinary teams to develop and execute dosing strategies to support new product development, domestic and international regulatory submissions.
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This candidate will provide clinical development leadership with responsibilities for the following key items:
Reporting to the V.P. Clinical Development, the candidate should have a proven track record of supporting compound development and IND and NDA filing of compounds
The finalist should have an MD or equivalent and 5 years of drug development experience.
Submit your resume for consideration for this role to Directorclinicalapplicant@trevenainc.com
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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