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.

Reporting to the CFO, the Director / Sr. Director, BD & Global Alliance Management will focus on the creation of new US / OUS business development opportunities for our commercial and pipeline products.  S/he will also manage working relationships with our current and future partners and play a key role in strategic planning. 

Essential Duties and Responsibilities:

  • Business Development
    • Work with internal stakeholders, including executive and R&D teams, to develop a comprehensive business development plan for commercial and pipeline candidates
    • Source, evaluate and structure new strategic business relationships, including licenses and partnerships; participate in relevant industry conferences and events to support the business development process
    • Create and deliver concise presentations to potential partners; lead negotiations and coordinate cross-functional due diligence process
    • Generate market / competitive analyses and develop product forecasts / models in collaboration with finance team
    • Present recommendations on deal terms and valuation to executive team
    • Track competitive landscape and report on significant developments
  • Alliance Management
    • Maintain strong relationships with current and future partners; oversee governance of alliances, including monitoring receipt of milestones and royalty payments
    • Communicate regularly with partner alliance management counterpart and coordinate cross-functional discussions as needed
  • Observes all Trevena policies, SOPs and safety guidelines
  • Other duties as assigned

Job Requirements:

Education:   

BS or MS in a scientific field of study; graduate level degree (MBA / MD / PHD) preferred.

Experience:

[10]+ years’ experience in the biopharma industry; BD, corporate strategy, consulting related roles will be considered

Knowledge, Skills and Abilities:   

  • Proven track record successfully negotiating / structuring partnerships and managing alliances; demonstrated analytical and organizational skills
  • Experience leading multiple BD / due diligence work streams efficiently and independently
  • Excellent oral and written communication and presentation skills; ability to understand and translate scientific / technical detail
  • Clear understanding of drug discovery, development and commercialization process
  • Broad BD network and a familiarity with latest partnership and alliance structures
  • Analytical, valuation and financial modeling skills
  • Familiarity with contract and IP law; experience coordinating with internal / external legal counsel to review in due diligence and contract negotiation processes
  • Positive, collaborative, hands-on work style with strong interpersonal skills
  • Strong attention to detail 

Equal Opportunity Employer

Director/Senior Director, BD & Global Alliance Management: Apply Now

SUMMARY

Trevena, a publicly-traded, commercial stage biopharmaceutical company located in Chesterbrook, Pennsylvania is is looking for a Biostatistician at the Associate Director level  to join our team.  Reporting to the Director, Quantitative Sciences, the Associate Director, Biostatistics will be responsible for all aspects of statistical design and analysis within the Company.

Specifically, the Associate Director, Biostatistics will;

  1. Serve as a member of core development teams to ensure that the appropriate statistical strategy is incorporated into the clinical development across all assets,
  2. Work closely with colleagues in Clinical Development, Clinical Operations, Nonclinical Development, Commercial, CMC, Medical Affairs and Regulatory Affairs to provide statistical expertise,
  3. Work closely with existing and future partners to ensure timely delivery of data, analyses, and interpretation required for approval and marketing in non-US markets,
  4. Work closely with the Commercial, Marketing and Regulatory Affairs teams to develop appropriate promotional material,
  5. Design, review and execute Statistical Analysis Plans in a timely manner using both internal and external partnerships and assure the studies are completed within the appropriate regulated environment,
  6. Establish and maintain relationships of partners who will perform statistical functions on the behalf of Trevena,
  7. Communicate with regulators as required including writing and defending biostatistical regulatory documents,
  8. Observes all Trevena policies, SOPs and safety guidelines,
  9. Other duties as assigned.

TRAVEL REQUIREMENTS

Up to 30% domestic/international travel.

EDUCATION & EXPERIENCE

  1. Graduate degree in statistics (M.S.,PhD or equivalent) and ideally 1-3 years of experience in biostatistics within the pharmaceutical/medical device industry. New Ph.D. graduates may be considered.

KNOWLEDGE, SKILLS & ABILITIES

  1. Demonstrated ability to identify multiple potential courses of action and describe related risks of each to non-technical audiences,
  2. Familiarity with appropriate regulatory guidelines,
  3. Working knowledge of CDISC standards,
  4. Excellent SAS programming skills,
  5. Knowledge of the R programming language is a plus,
  6. High attention to detail.
Associate Director, Biostatistics: Apply Now

SUMMARY

Reporting to the Head, CMC and Analytical Development, the Associate Director of Chemical Development and API manufacturing is responsible for all development and manufacturing activities related to the drug substance with a broad knowledge of drug development process.  The Associate Director will support the achievement of operational objectives within CMC/Pharmaceutical Development, ensuring alignment to Trevena company strategy and objectives. 

Specifically, the Associate Director of Chemical Development and API Manufacturing will be responsible for:

  1. API chemical process development and solid-state development/characterization in support of drug product development,
  2. Manufacturing of non-GMP and GMP API batches (clinical through commercial) and identification, selection, and sourcing of starting materials to support API manufacturing,
  3. Evaluation of stability data and impurity identification/synthesis, evaluation of physico-chemical data of lab scale/pilot scale batches and adjustment of processes and methods as needed,
  4. Leading/managing the DOE study to finalize the API process and the process validation,
  5. Developing/implementing strategies to reduce the COGS of API and regulatory starting materials (RSM) while also maintaining a robust supply of API and RSM,
  6. Preparation of CMC documents related to clinical trial applications and authoring Drug Substance section for IND, IMPD, NDA, and sNDA filings,
  7. Selection and management of CMOs, executing CMC activities,
  8. Collaboration with Internal Quality and Compliance department to assure that CROs are performing according to cGMPs,
  9. Interaction with analytical and drug product CMC team members to build the CMC development plan and ensure execution thereof,
  10. Representing the CMC team in the cross-functional development team(s),
  11. Observes all Trevena policies, SOPs and safety guidelines,
  12. Other duties as assigned.

TRAVEL REQUIREMENTS

Up to 10% domestic/international travel.

EDUCATION & EXPERIENCE

  1. PhD in chemistry or related field or equivalent,
  2. 8+ years of experience working in drug development, especially in small molecule drug substance development/upscaling,
  3. Experience in the preparation of drug substance development reports for the CMC section of IND/IMPD and/or NDA submissions,
  4. Experience working in a virtual organization and managing CROs.

KNOWLEDGE, SKILLS & ABILITIES

  1. Strong knowledge of functional area, including deep knowledge of physical chemistry, solid state chemistry, organic synthetic chemistry and reaction mechanisms,
  2. General understanding of related functional areas within and beyond CMC,
  3. Ability to ensure alignment of methods, techniques and functional objectives with company strategy and organizational objectives,
  4. Demonstrated understanding of drug development including knowledge of drug discovery, clinical trials, and regulatory requirements for GMP API, regulatory starting materials, and GMP process,
  5. Strong analytical skills with a demonstrated ability to think strategically,
  6. Strong problem-solving skills with a track record of identifying and implementing novel solutions,
  7. Solid negotiation skills in quotation and a persuasive project management style when working with CMO/CRO to achieve company’s business and technical objectives,
  8. Transparent and direct communication styles internally and externally,
  9. Able to work in a fast-pace and constantly changing working environment.
Associate Director, Chemical Process Development & API Manufacturing: Apply Now

SUMMARY

Reporting to the Head, CMC and Analytical Development, the Director/Senior Director of Pharmaceutical Development is an experienced pharmacist/chemist with a broad knowledge of drug development.  The Director/Senior Director of Pharmaceutical Development will support the achievement of operational objectives within CMC/Pharmaceutical Development, ensuring alignment to Trevena company strategy and objectives. 

Specifically, the Director/Senior Director of Pharmaceutical Development will be responsible for:

  1. Drug product formulation development and process development, including evaluation of physical characteristics of development API (solubility, particle size, etc.), evaluation of early clinical and non-clinical data (pK, tox., etc.) and stability data (potency, impurity/degradants, etc.) of lab scale/pilot scale batches and adjustment of processes and methods, as needed,
  2. Working within the team to identify and qualify vendors and third-party manufacturers,
  3. Manufacturing of non-GMP and GMP batches, including batches to support clinical trials,
  4. Oversee the labeling and distribution of clinical trial materials,
  5. Leading/managing the DOE study to finalize the DP process and process validation,
  6. Developing/implementing strategies to reduce the COGS of drug product,
  7. Preparation of CMC documents related to clinical trial applications and providing technical support for NDA and sNDA filings,
  8. Selection and management of contractors executing CMC activities – including development work, process scale-up and CTM manufacturing,
  9. Collaboration with internal Quality and Compliance department to assure that CROs are performing according to cGMPs,
  10. Interaction with analytical and drug substance CMC team members to build the CMC development plan and ensure execution thereof,
  11. Representing the CMC team in the cross-functional development team(s),
  12. Observes all Trevena policies, SOPs and safety guidelines,
  13. Other duties as assigned.

TRAVEL REQUIREMENTS

Up to 10% domestic/international travel.

EDUCATION & EXPERIENCE

  1. PharmD, PhD in chemistry, related/equivalent qualifications,
  2. 10+ years of experience working in drug development, especially in drug product development/upscaling,
  3. Experience in the preparation of drug product development reports for the CMC section of IND/IMPD and/or NDA submissions,
  4. Experience working in a virtual organization and managing CROs,
  5. Experience with sterile injectable, solid oral, and alternative dosage forms.

KNOWLEDGE, SKILLS & ABILITIES

  1. Strong knowledge of functional area,
  2. General understanding of related functional areas,
  3. Ability to ensure alignment of methods, techniques and functional objectives with company strategy and organizational objectives,
  4. Demonstrated understanding of drug development including knowledge of drug discovery, clinical trials, and regulatory requirements for INDs, IMPDs, and NDAs,
  5. Strong analytical skills with a demonstrated ability to think strategically,
  6. Deep knowledge of physical properties, pharmacology, clinical trial supply,
  7. Strong problem-solving skills with a track record of identifying and implementing novel solutions,
  8. Solid negotiation skills in quotation and a persuasive project management style when working with CMO/CRO to achieve company’s business and technical objectives,
  9. Transparent and direct communication styles internally and externally,
  10. Able to work in a fast-pace and constantly changing working environment.
Director/Senior Director of Pharmaceutical Development: Apply Now

PURPOSE

Reporting to the Vice President, Scientific Operations, the Director of Project Management will provide strategic leadership, operational management, support, and oversight of commercial-, clinical- and discovery-stage development project teams.  As part of a cross-functional team, he/she will be responsible for all planning and execution of activities related to the project teams’ work, and ensure that all program deliverables are implemented on time, within scope, and on/or under budget. 

Specifically, the Director of Project Management will:

  1. Work with cross-functional teams to define project strategy, scope, goals and deliverables to support business objectives in collaboration with senior management and stakeholders.
  2. Create agendas, minutes and presentations to lead project team meetings and ensure action items are completed.
  3. Oversee project timelines, project budgets and resource tracking tools.
  4. Work with Finance to ensure that appropriate budgets and forecasts are maintained to deliver agreed upon milestones.
  5. Develop presentations, analyses and recommendations for the executive leadership and stakeholders.
  6. Proactively identify risks and identify/implement mitigation plans.
  7. Raise and clearly communicate critical issues and their impact to the appropriate stakeholders in a manner that results in resolution and allows others to do the same.
  8. Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.
  9. Participate in meetings with regulatory authorities.
  10. Observe all Trevena policies, SOPs and safety guidelines.
  11. Perform other duties as assigned.

TRAVEL REQUIREMENTS

Up to 10% domestic/international travel.

EDUCATION & EXPERIENCE

  1. BS/MS in scientific field required.
  2. Ten years’ experience leading clinical stage projects in the pharmaceutical/biotech industry.
  3. Previous experience interacting with regulatory authorities preferred.
  4. Experience developing drugs that target the central nervous system preferred.
  5. Experience managing others is preferred.

KNOWLEDGE, SKILLS & ABILITIES

  1. In-depth knowledge of drug development process (i.e. experience in discovery-stage and Phase I - IV clinical development programs, regulatory submissions and commercialization).
  2. Substantial knowledge of clinical and preclinical development, CMC, QA, regulatory affairs, commercial and BD.
  3. Proven track record of successful IND and/or NDA filings.
  4. Strong sense of urgency with the ability to proactively identify and respond to issues and opportunities.
  5. Demonstrated strategic thinker with the ability to continuously consider the broader company impact of decisions and actions.
  6. Ability to influence and partner with line managers to complete project tasks in a timely fashion.
  7. Ability to manage project-specific timelines and budgets.
  8. Excellent written and oral communication skills. Outstanding presentation skills.
  9. Results oriented with a track record of taking full accountability for actions and outcomes.
  10. Resourceful and creative with a demonstrated ability for tackling challenges with enthusiasm.
  11. Outstanding interpersonal skills.
Director, Project Management: Apply Now

SUMMARY

Responsible for proactively executing on regulatory affairs activities both within and outside the U.S. including, but primarily in the US: (i) executing regulatory interactions, (ii) providing project regulatory interpretation, strategy and guidance, (iii) coordinating regulatory activities handled by vendors and/or CRO’s, and (iv) anticipating and guarding against regulatory risks facing the Company.

ESSENTIAL FUNCTIONS

  • Partner with health authority project managers and review teams to represent their perspective in the Company.
  • Develop regulatory strategy for development and commercial projects.
  • Provide regulatory guidance and support to various departments including Clinical Research, Manufacturing, Commercial and Business Development.
  • Analyze regulatory history and competitor information to provide regulatory intelligence across relevant therapeutic areas and indications.
  • Review promotional and non-promotional materials for marketed products, and lead the Medical-Legal-Regulatory Review process
  • Coordinate project regulatory operations services.
  • Manages, drafts, and aids in securing internal approval of FDA meeting requests and briefing books.
  • Manages labeling documents, including preparing package inserts, as well as aiding in quality control of labeling submissions.
  • Responsible for managing the compilation, submission and maintenance of INDs, NDAs, amendments and supplements.
  • Support and participate in the Company’s due diligence activities in evaluating potential products for acquisition/in-licensing/joint development opportunities.

SUBORDINATES

None; but will manage a network of consultants and vendors.

JOB REQUIREMENTS

Technical Skills/Knowledge

  • 7+ years of regulatory experience in the pharmaceutical or biotechnology industry, preferably in an in-house capacity.
  • Experience in working with development project teams in a regulatory leadership role.
  • Experience with FDA regulations and their impact across the entire development cycle including promotion of pharmaceutical products and labeling.
  • Experience across multiple therapeutic areas is a plus.
  • Ability to provide strategic and operational guidance across all levels of the company and external vendors.

Independence/Accountability

  • Normally receives no instructions on routine work.
  • Receives detailed instruction on new assignments only and determines next steps with guidance.
  • Define and review goals and objectives and inform management team of changes in objectives and timelines.
  • Must be a self-starter, resourceful and able to participate in a highly collaborative, team-oriented environment.
  • Must be able to handle, prioritize and follow through on a high volume of work, including the ability to anticipate and manage changing priorities and timelines.
  • Must have a strong commitment to corporate compliance.Must be able to work virtually, both as a member of teams and independently.

Problem solving

  • Has the ability to work on complex problems in which analysis of situations requires an in-depth evaluation of various factors.
  • Suggests and implements solutions to problems.

Leadership Activities

  • Expected to assist others with problem solving.
  • Proposes ideas and presents data within own group.
  • Participates in interdisciplinary team meetings.
  • Is accessible to others for technical advice.
  • Highest personal integrity; committed to ethics and scientific standards
  • Ability to influence those over whom there is no immediate supervisory capacity to achieve objectives
  • Ability to interface with internal customers and stakeholders, industry contacts, and consultants to accomplish corporate objectives

Communication Skills

  • Excellent communication skills, both oral and written.
  • Must work well with others.
  • Actively participates in own team meetings.
  • Assists other departments as necessary.

Customary Education and Experience

  • B.S. in life sciences or chemistry discipline
  • Additional regulatory education and/or certification is a plus.
  • Some travel required.

PHYSICAL DEMANDS

  • Physical demands consistent with working in an office and laboratory setting.

WORKING CONDITIONS

  • Office and virtualsettings
  • Moderate noise level
  • Flexible hours.
  • May be required to work on off hours and weekends
Director, Regulatory Affairs: Apply Now

SUMMARY

Reporting to the Senior Director Medical and Scientific Communications, the Manager/Associate Director Medical Information and Drug Safety has responsibility for managing the outsourced call center which provides verbal and written responses to queries from healthcare professionals and collects the necessary information on adverse events and product complaints regarding OLINVYK.  This role also provides primary oversight of the pharmacovigilance vendor providing post marketing adverse event tracking, follow up and reporting.

Specifically, the Manager/Associate Director, Medical Information and Drug Safety will be able to successfully accomplish the following responsibilities:

  1. Manage the externally-sourced Medical Information call center and act as point of contact to answer brand-specific questions and writing and reviewing answers given to external HCP customers as required,
  2. Writing standard response documents (SRDs) by searching, retrieving, evaluating and summarizing the relevant information from in-house and external data sources and literature,
  3. Update SRDs to maintain a current and accurate information resource for the call center,
  4. Provide ongoing product-related and SRD training for the call center staff,
  5. Monitor call center for quality and performance. Collect and analyze metrics for call center activities (including Medical Information, Pharmacovigilance, and Product Complaints) to assure timely and accurate responses or routing to appropriate internal departments for review and action; provide a report on a regular basis,
  6. Oversee and manage the call center and Pharmacovigilance vendor budgets, POs, and invoices,
  7. Develop and conduct regular assessments to ensure compliance with SOPs consistent with all legal, regulatory, and Company guidelines,
  8. Collect and analyze types of customer requests to provide input to brand strategy,
  9. Ensure timely delivery of peer-reviewed publications, AMCP Dossier or other relevant materials to HCPs upon request,
  10. Support medical information booth activities at key congresses,
  11. Provide training support for multiple internal customers (including but not limited to Sales team members, Health Economic/Medical Science Liaisons),
  12. Provide information support for commercial activities of the Brand Team (literature updates, literature searches; competitor information),
  13. Conduct medical data quality control (QC) reviews of promotional and non-promotional materials (as part of Medical-Legal Review) as requested,
  14. Manage Pharmacovigilance vendor to ensure appropriate follow up of adverse events and timely submission of pharmacoviglance reports to the Food and Drug Administration,
  15. Work with Pharmacovigilance vendor, consultant and/or Trevena physicians to complete causality and regular signal detection assessments,
  16. Manage Pharmacovigilance and Call Center vendors in response to drug safety and/or Medical Information audits,
  17. Observe compliance with all Trevena policies, SOPs and safety guidelines,
  18. Other duties as assigned.

EDUCATION & EXPERIENCE

  • Registered pharmacist or Nurse (BSN); Advanced scientific degree (eg. Pharm D) preferred but not required
  • Minimum of 2 years of experience in Medical Information within the pharmaceutical industry; Drug safety experience a plus
  • Background/experience in opioid medications, IV analgesic medications preferred but not required.
  • Experience working with Medical Information vendor preferred

KNOWLEDGE, SKILLS & ABILITIES

  • Working knowledge of IRMS or other MI software,
  • Must possess the ability to work across a matrix organization including: R&D, Regulatory, Legal, Commercial Operations, et cetera,
  • Strong communication skills (verbal and written),
  • Strong attention to detail,
  • Strong personal integrity and customer focus are imperative,
  • Thorough understanding of and compliance with the FDA, OIG, HIPAA, PhRMA and other regulatory/ethical guidelines relevant to the pharmaceutical industry.

Additional Preferred Skills

  • Familiarity with pain management journals, and pain medical societies,
  • Sound computer skills including Microsoft Word, and Powerpoint,
  • Familiarity with PV software and reporting (eg. ARISg),
  • Knowledge of the pharma marketplace and hospital selling environment,
  • Familiarity with study design and statistical methodology,
  • Experience working with medical, marketing and sales teams,
  • Self-motivated and able to work in a fast-paced biotech environment.

Location:  Trevena headquarters office in Chesterbrook, PA

Manager/Associate Director, Medical Information and Drug Safety: Apply Now

SUMMARY

Reporting to the Vice President Medical Affairs, the Senior Director, Medical Affairs has responsibility for leading the development of brand medical strategy and execution of medical affairs activities that include engaging in scientific communications with KOLs and clinical experts, training and support of Field Medical Affairs teams, contributing to publication development and strategy, Advisory Boards, Congress activities, support of Phase 4 studies (including Investigator-Initiated Trials (IITs), and health economics projects.

Specifically, the Senior Director, Medical Affairs will be able to successfully accomplish the following responsibilities:

  1. Oversee/lead medical strategic and tactical planning for OLINVYK in the US working collaboratively with Commercial Operations, Clinical Development, Medical Information, Health Economics, and Field Medical Affairs teams (e.g., Health Economic/Medical Science Liaisons),
  2. Develop a cross-functional medical brand plan for OLINVYK and serve as a medical/scientific brand expert facilitating the development and implementation of, or providing support for the following broad-based initiatives:
    • KOL engagement
    • HE/MSL and field sales training
    • Medical and scientific communications and presentations
    • Advisory boards
    • Medical Congress activities
    • Slide library development
    • Phase 4 clinical trials and IITs,
    • Health economics research projects,
  3. Establish and foster professional relationships with KOLs and academic institutions; develop and execute Company Headquarter-based engagement plans,
  4. Provide clinical presentations alone or in conjunction with Health Economic/Medical Science Liaisons as needed to hospital P&T Committees and key health care decision makers (HCDMs),
  5. Assist with medical review of product advertising and promotional materials,
  6. Review and provide medical expert input into Medical Information responses (e.g., development and review of Standard Response Letters) and scientific publications,
  7. Observe compliance with all Trevena policies, SOPs and safety guidelines,
  8. Other duties as assigned.

EDUCATION & EXPERIENCE

  • Advanced scientific degree (e.g., PharmD, PhD, MD) required,
  • Minimum of 5 years experience with a thorough understanding of Medical Affairs activities within the pharmaceutical industry,
  • Background/experience in Acute Pain/opioid medications, hospital IV analgesic medications highly preferred.

KNOWLEDGE, SKILLS & ABILITIES

  • Team leadership and/or management experience preferred,
  • Must possess the ability to work across a matrix organization including: R&D, Regulatory, Legal, Commercial Operations, et cetera,
  • Strong presentation and communication skills (verbal and written),
  • Strong attention to detail,
  • Strong personal integrity and customer focus are necessary,
  • Thorough understanding of and compliance with the FDA, OIG, HIPAA, PhRMA and other regulatory/ethical guidelines relevant to the pharmaceutical industry.

OTHER PREFERRED SKILLS

  • Familiarity with pain management journals, and pain medical societies,
  • Basic knowledge of Health Economic models,
  • Existing network of KOL contacts and relationships in acute pain therapeutic area,
  • Sound computer skills including Microsoft Word, and Powerpoint,
  • Understanding of Marketing concepts/strategies,
  • Knowledge of the pharma marketplace and hospital selling environment,
  • Familiarity with study design and statistical methodology,
  • Experience working with medical, marketing and sales teams,
  • Ability to operate within a rapidly changing environment, while maintaining a sense of humor, and inspiring others to collaborate effectively.

TRAVEL REQUIREMENTS

Up to 30% domestic travel

Location:  Trevena headquarters office in Chesterbrook, PA

Senior Director, Medical Affairs: Apply Now

SUMMARY

Reporting to the Chief Medical Officer, the Vice President, Health Economics and Medical Science has responsibility for the medical leadership and strategic direction of all activities involving Health Economics, Formulary Access, and Medical Science research activities (Investigator-Initiated Studies and Medical Education Grant review) within the Medical Affairs Department, ensuring operational excellence, integrity, and continual improvement.

Specifically, the Health Economics and Medical Science Liaison will be able to successfully accomplish the following responsibilities:

  1. Provide scientific data presentations to formulary committees and other key HCDMs of the health economic model and associated clinical data, and serve as the field-based face of the organization to address questions about these data.
  2. Work with the Vice President, Health Economics and Medical Science to assist in the design and development of communication materials to enable robust discussions of the health economic model and the value proposition for the lead product, OLINVYK, to assigned HCDMs and key health care systems.
  3. Possess extensive knowledge of health economic model design and analysis and be able to present complex ideas in a straightforward and understandable manner to HCDMs. Possess a deep understanding of cost-effectiveness models, budget impact models.
  4. Understand the content and format of product dossiers, such as the AMCP dossier, and other scientific materials, and their appropriate use to achieve formulary access. Possess a deep understanding of the landscape to ensure regulatory compliance and integrity in all interactions with HCDMs and their institutions.
  5. Understand the hospital reimbursement environment and the processes associated with formulary access and Pharmacy and Therapeutics Committees. Seek input from relevant HCDMs on potential demonstration projects of interest.
  6. 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.
  7. Collaborate with peer company colleagues in Medical Affairs, Quantitative Sciences, Nonclinical Development, CMC/Manufacturing, Business Development, and Commercial Affairs, as required, to advance potential clinical development collaborations for the lead product, OLINVYK, at key academic institutions and assist in appropriately directing these opportunities to the Company’s Investigator-Initiated Studies program.
  8. Establish and foster professional relationships with KOLs and other academic scientists, and related business partners, consultants and vendors.
  9. Foster a collaborative, motivating, innovative, problem-solving culture and mindset. 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. Observe compliance with all Trevena policies, SOPs and safety guidelines.
  12. Other duties as assigned.

TRAVEL REQUIREMENTS

Up to 75% domestic travel.

EDUCATION & EXPERIENCE

  1. Minimum 3 years of experience in Medical Science Liaison role, with emphasis on Health Economics outcomes research.
  2. Minimum 3 years of experience in a an MSL role with primary emphasis on/knowledge of P&T committee processes.
  3. Hospital experience is strongly preferred.
  4. Expertise in neuroscience development and/or opioids and pain management 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. Strong presentation and communication skills (verbal and written) with ability to clearly communicate results, plans, issues, and risks.
  3. Strong attention to detail.
  4. Extensive knowledge of health care economics and the hospital reimbursement environment.
  5. Ability to operate within a rapidly changing environment, while maintaining a sense of humor, and inspiring others to collaborate effectively.
Vice President, Health Economics and Medical Science: 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