Careers

Join Our Team

At Trevena we believe in our science and in the people that make it possible. Every employee is critical to our success and we strive to make sure that every voice is heard. The company’s goals, challenges and successes are clearly outlined, and we work as one team to make the organization successful. Every employee has an opportunity to impact Trevena’s success and to benefit personally from that success as a shareholder of the company.

At Trevena, we have built a great team who are committed to groundbreaking 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.

SUMMARY

The Director, QA will support the GXP compliance and Quality Unit function at Trevena. Primary responsibilities will include ensuring the compliance with cGCPs, though the Director, QA may also provide support with GLPs, GMPs, and QA systems.

Specifically, the Director, QA will

  1. Partner with clinical development and clinical operations teams to design strategy and plan/schedule GCP compliance programs.
  2. Execute on plans to improve and grow the GCP quality systems in a timely manner using both internal and external partnerships.
  3. Create, maintain and train team members on Trevena GCP SOPs.
  4. Manage GCP documentation retention activities.
  5. May serve as point person for quality inspections of Trevena.
  6. Communicate audit findings clearly with internal/external customers and auditees. Provide guidance, solutions and advice on complex problems related to quality and GCP compliance.
  7. Partner with the VP, Clinical Operations to resolve any issues that may arise during clinical development.
  8. Provide support in other areas of QA, including GLP, GMP and QA systems, as needed.
  9. Observes all Trevena policies, SOPs and safety guidelines.
  10. Other duties as assigned.

TRAVEL REQUIREMENTS

Up to 25% domestic/international travel.

 

EDUCATION & EXPERIENCE

  1. BS in life sciences or related field required. MS in QA or related field preferred.
  2. 7 years of QA experience in the pharmaceutical industry.
  3. 5 years in GCP compliance and quality.

KNOWLEDGE, SKILLS & ABILITIES

  1. Broad knowledge of drug-development regulatory requirements and proficiency in ICH guidelines and FDA/international regulations relating to clinical development.
  2. Experience with clinical trial logistics, including auditing and assessing capabilities of potential clinical and non-clinical development programs from a quality and compliance perspective.
  3. Significant experience managing external partners.
  4. Strong leadership skills, including effective facilitation and communication abilities
  5. Strong judgement and decision-making skills.
  6. Demonstrated ability to manage multiple projects simultaneously.
  7. Proficient computer skills i.e. Microsoft office, databases, electronic documentation system are required

TREVENA IS PROUD TO BE AN EQUAL OPPORTUNITY EMPLOYER WITH A DIVERSE TEAM.

Director of Quality Assurance: Apply Now

SUMMARY

Reporting to the Chief Medical Officer, the Vice President, Medical Research has responsibility for the medical leadership and strategic direction of medical research activities ensuring operational excellence, integrity, and continual improvement.

Specifically the Vice President, Medical Research will be able to successfully accomplish the following responsibilities:

  1. Directly supervise and provide management oversight of the Clinical Operations team, and provide medical leadership in collaboration with the Vice President, Quantitative Sciences and Clinical Development.
  2. Work with the Chief Medical Officer to develop appropriate project plans for all development candidates. Communicate plans effectively to Clinical Operations team members, and also report project progress as requested to Senior Management and Board of Directors.  Design appropriate budgets to accomplish project plans, and delegate team members accordingly.
  3. Organize the various functional leaders within the Clinical Operations team to effectively identify project goals, and to provide operational leadership to help the team to complete tasks on time and on budget.
  4. Identify needs, initiate and lead diverse strategic operational initiatives and re-challenge existing ones to improve effectiveness and efficiency. Maintain appropriate documentation of project plans including timelines, milestones and spending to budget.
  5. Collaborate with peer company colleagues in Medical Affairs, Quantitative Sciences, Nonclinical Development, CMC/Manufacturing, Business Development, and Commercial Affairs, and provide necessary work to complete cross-functional goals as required, ensuring an effective program of priority setting, budgeting and resource deployment across collaborating departments.
  6. Manage and oversee financial and budgetary aspects of Clinical Operations.
  7. Establish and foster professional relationships with study investigators, academic scientists, other business partners, consultants and vendors ensuring that vendor responsibilities are met, including performance, compliance and reporting.
  8. Possess extensive knowledge of drug development programs across all phases, clinical trials methodology, regulatory requirements for effective clinical trial management, clinical operations, and project management skills.
  9. Foster a collaborative, motivating, innovative, problem-solving culture and mindset and develop high-performing clinical trial management teams. Take the initiative in solving problems, not simply identifying them.
  10. Ensure high-quality operational execution with equal emphases on successful interpersonal communication, respect and engagement with colleagues, and scientific and strategic excellence.
  11. Ensure that all studies meet regulatory requirements and are conducted to GCP standards globally.
  12. Lead interactions with regulatory authorities and serve as the expert voice of Clinical Development on behalf of the company when necessary.
  13. Observe compliance with all Trevena policies, SOPs and safety guidelines.
  14. Other duties as assigned.

TRAVEL REQUIREMENTS

Up to 30% domestic/international travel.

 

EDUCATION & EXPERIENCE

  1. MD or PhD or PharmD degree.
  2. At least 10 years of pharmaceutical industry experience.
  3. Expertise in neuroscience development is strongly preferred.

KNOWLEDGE, SKILLS & ABILITIES

  1. A high level of integrity and respect for others, and a strong sense of enjoyment in seeing their team succeed.
  2. Capable of triaging projects in a sophisticated manner, with the ability to identify multiple potential courses of action and describe related risks of each to non-technical audiences.
  3. Experienced team leadership and project management skills.
  4. Demonstrated ability to formulate tactical and strategic recommendations to executive leadership.
  5. Strong presentation and communication skills (verbal and written) with ability to clearly communicate results, plans, issues, and risks.
  6. Strong attention to detail.
  7. Extensive knowledge of clinical trial methodology.
  8. Ability to operate within a rapidly changing environment, while maintaining a sense of humor, and inspiring others to collaborate effectively.
Vice President, Medical Research: Apply Now