Career Opportunities

AVEO Pharmaceuticals, Inc. is looking for an experienced CMC Regulatory Affairs professional who wants to play an integral role in building a regulatory infrastructure at AVEO.  This individual will become a part of a dynamic and talented team focused on the discovery and development of novel, targeted cancer therapeutics.  This is an excellent opportunity for someone who thrives in a creative environment and excels in leadership roles.  The Associate Director will be responsible for overseeing and managing all CMC regulatory activities to support high priority oncology programs.

This individual will report to the Head of Regulatory Affairs, who is dedicated to ensuring an exciting career development opportunity at AVEO based on ability, growth and motivation.

Responsibilities
•    Responsible for the oversight and management of all CMC regulatory activities (US and EU/ROW) to support oncology clinical trials
•    Develop effective CMC regulatory strategies for global product development (investigational and ultimately commercial)
•    Represent CMC regulatory at relevant strategic and operational teams (e.g., Global Development Team and Regulatory and Clinical Subteam meetings)
•    Apply knowledge of key global CMC guidance documents, regulations, or directives and effectively communicate any impact on AVEO's development programs
•    Liaise with regulatory authorities (FDA, EMEA, HC, etc.) regarding CMC aspects for all programs
•    Interface with manufacturing contractors when necessary
•    Lead all regulatory activities to support high quality CMC sections of regulatory documentation (e.g., INDs, NDAs, CTAs, briefing documents, post-approval supplements, etc.)
•    Develop and maintain/manage timelines for the preparation of CMC submissions
•    Ensure compliance with existing regulatory applications (e.g. IND/CTA maintenance)
•    Contribute to the development and implementation of processes and standards

Qualifications
 
•    BA/BS or equivalent, preferably in Chemistry, Biochemistry, Biology, or Pharmaceutical Science; advanced degree preferred
•    Minimum of 6-8 years regulatory affairs experience
•    Extensive knowledge of US/EU CMC regulatory requirements, with the ability to apply knowledge both strategically and operationally to development projects
•    Strong knowledge of current Good Manufacturing Practices (cGMP)
•    Previous experience in leading submission teams for investigational products and marketing applications
•    Direct experience with interacting with regulatory health authorities
•    Experience and knowledge in the preparation of global regulatory CMC submissions (e.g. INDs, CTAs, amendments, NDA/BLA/MAA, briefing documents to support milestone health authority meetings)
•    Knowledge and understanding of applicable global CMC regulations
•    Knowledge of eCTD content/format requirements strongly preferred
•    Ability to lead and influence cross functional teams and committees
•    Strong interpersonal skills and the ability to deal effectively with a variety of personnel, including medical, scientific, and manufacturing staff
•    Must demonstrate strong and effective project management, problem-solving, and negotiating abilities
•    Excellent verbal and written communication skills are essential
•    Proficiency with MS Project is desired

We are seeking a highly motivated, independent bioinformatics scientist to join a group of scientists, analysts and programmers to develop tools and methodologies for large-scale gene expression data analysis.  The group supports a variety of research projects in target and drug discovery as well as biomarker development for AVEO’s growing pipeline of novel anti-cancer drugs.

AVEO’s Translational Research program utilizes a novel platform combining proprietary, inducible tumor models and bioinformatics approaches to discover, validate and generate therapeutics against molecular targets in oncology.  We have generated large populations of tumors that exhibit inter-tumor heterogeneity similar to that seen in human tumor populations. Each tumor has been characterized by microarray, array CGH, histology, key signaling pathways as well as sensitivity to a variety of cancer therapeutics, including AVEO’s clinical stage drug candidates.  This well-characterized tumor population model system enables the correlation of gene expression and DNA copy number with drug efficacy, providing an attractive platform for the creative innovative bioinformatics scientist to develop and test translational hypotheses. Our goal is  to use the platform to inform clinical trial design regarding tumor, tumor subtype and patient selection for AVEO’s own clinical stage oncology drug candidates.

Responsibilities

The candidate will:

• Participate in generating, processing and evaluating large oncology-related datasets. 
• Work on a variety of high-dimensional data projects largely centered on biomarker discovery and develop biomarkers for response to therapy and disease subtype classification.
• Execute a wide range of computational and analytical tasks, including developing and implementing algorithms for target identification and biomarker discovery.
• Integrate publicly or commercially available genomic data with novel experimental data.
• Identify and execute innovations (computational, statistical, and strategic) that will quantifiably improve Projects.
• Identify new datasets and data mining techniques relevant to cancer target and drug discovery
• Develop and test novel methods and algorithms, working with academic collaborators where opportunities arise.

Qualifications & Requirements

• PhD in Biology, Bioinformatics, or equivalent, as well as 2+ years of full time experience in an academic or biotechnology industry lab, or equivalent experience.
• Interest in, and working knowledge of cancer biology.
• A solid understanding of statistics. Have experience with a broad range of statistical methods for classification and prediction, e.g., linear models, machine learning, and other multivariate analysis methods.
• Programming experience and ability to write R and Perl script.
• The candidate will have experience with large-scale genomics data and a solid understanding of bioinformatics data bases (eg: GenBank, RefSeq, dbSNP etc).
• Experience with some bioinformatics software such as: Spotfire, Partek, Ingenuity, GeneGo, Balst, and Blat.
• The candidate will have the ability and interest in learning new techniques and skills in accordance with evolving research program needs.
• Candidates with a proven ability to work efficiently in a team setting, and excellent communication skills are preferred. 

Aveo Pharmaceuticals, Inc. is looking for an experienced clinical data management professional.  The incumbent will be responsible for handling data management on multiple global clinical trials.  The incumbent will oversee CROs and ensure that the data management objectives are met in accordance with current SOPs and timelines.  The incumbent will also provide assistance in protocol review and form design for newly conceived trials working either in the EDC or paper data management environment. Experience with data management on late stage oncology trials is strongly preferred.

Responsibilities 

• Oversee data management activities performed by CROs.
  • Review of CRFs for completeness, content, standards, and database considerations
  • Review of Database specifications
  • Review and Management of Data Management Plans
  • Perform data review periodically for quality issues and general data trends
  • Perform SAE review between CRF data and safety database
  • Oversee the management of non-CRF data for file format and timelines
  • Oversee the management of timelines of CROs
• Ensure adequate filing and archiving of relevant data and documentation.
• Work effectively as a team player with Biostatistics, Clinical, Medical, and Regulatory staff.

Qualifications 

• BA/BS degree or equivalent in a scientific or health care field preferred.
• Minimum of 5 years experience in clinical data management in the pharmaceutical/ biotechnology/ CRO setting.
• Knowledge of medical terminology required.
• Knowledge of coding dictionaries (MedDRA, WHO Drug).
• Excellent verbal and written communication skills as well as interpersonal and organizational skills.
• Attention to detail, ability to prioritize and handle multiple projects.
• Knowledge of Electronic Data Capture (EDC) and related tools and processes.
• Proficiency in MS Office applications.
• Proficiency with data management systems.
• Knowledge of database design and database concepts.
• Experience with lab data is a plus.
• Preferable but not required: SAS, SQL, Access.
• Occasional business travel may be required (domestic and international).

In this newly created position, the Financial Planning & Analysis Manager will be directly responsible for managing the annual budget, monthly forecast, and longer range planning

Responsibilities

• Lead the annual budget process and longer range planning process
• Lead the monthly forecast process to update corporate operating forecast
• Initiate rolling monthly forecast
• Implement new budgeting software package
• Prepare quarterly closing accruals/estimates
• Coordinate monthly preparation and distribution of budget reports
• Develop and prepare reporting analyses including performance versus last year , performance versus budget and analysis of trends
• Design, develop and produce ad-hoc reports and analytical models to support the business
• Participate in other projects as required

Qualifications

• Bachelor's degree or higher in Finance, Accounting or Business Administration, MBA is preferred
• 3+ years of experience in business analysis or budgeting
• Previous biotech/pharmaceutical experience preferred
• Strong analytical and problem solving skills
• Excellent communication, organizational skills and interpersonal relationship skills required
• Proficient in excel and facility in financial modeling required

We are seeking an experienced Human Resources professional with strong generalist and compensation background to join a dynamic oncology biotechnology company in late-stage clinical development with plans for an NDA and commercialization in two years’ time.

This incumbent will report to the Senior Director of Human Resources and will be an integral member of the HR team, playing a key role in delivering the full range of human resources services to a large segment of the Company, including employee relations, non-executive compensation programs, change management, performance & talent management, HRIS, and benefits. 

Responsibilities include but are not limited to the following:

• Providing proactive HR consultation/services to assigned groups. 
• Providing expertise to managers and employees on a broad range of issues (e.g., employee relations, performance issues, talent management, compensation, organizational issues).  Partnering with legal counsel and recommending appropriate course of action if appropriate.
• Partnering with recruiter on staffing issues, which may involve identifying and interviewing candidates.
• Conducting annual compensation market analysis, participating in industry salary surveys, and developing/ reviewing internal non-executive compensation structures.
• Overseeing HRIS and scaling up HR infrastructure and processes to meet current and anticipated needs of a growing organization
• Assisting in the development and implementation of HR policies, procedures, and communication plans.
• Spearheading HR projects as they arise, such as development of career ladders.
• Participating in the Employee Activities Committee to promote positive employee morale.
• Maintaining regulatory and legal compliance programs (e.g., AAP, EEO) in partnership with Corporate Counsel as needed.
• Fostering collaborative relationships with Finance, Legal, Administration, and all other key internal stakeholders and partnering on cross-functional projects and initiatives.

Qualifications

• Bachelor’s degree or equivalent work experience required
• 8+ years of human resources experience including experience in the areas of employee relations, compensation and HRIS
• Demonstrated ability to address HR issues in a fast paced, dynamic, growing environment
• Strong interpersonal and communication skills with the ability to work effectively with all levels of the organization and a strong team orientation
• Experience from a commercialized biotechnology/pharmaceutical organization is highly desirable
• Excellent computer skills: MS Outlook, Excel, PowerPoint; experience with web-based HRIS

This newly created position will be reporting directly to the  Vice President of Clinical Research and will be an integral member and leader of the Company’s evolving clinical organization and infrastructure.  This person will play a key role in helping to advance Aveo’s novel technology and compounds into clinical trials, with a particular focus on Tivozanib clinical and translational programs.

The incumbent will be responsible for strategic development and implementation of all the Company’s Clinical Oncology programs, including the following: design and implementation of all clinical trials, selection of indications, clinical sites, and investigators.  The person will develop protocols, clinical timelines, budgets, and study related documents as well provide overall direction to the clinical sites.  Further, the incumbent will ensure compliance with all applicable regulatory guidelines.

Additional responsibilities include but are not limited to the following:

• Providing medical guidance and leadership to AVEO’s translational research department as well as regulatory affairs to ensure maximum scientific and regulatory input to study design.
• Presenting AVEO’s clinical programs externally, at meetings with scientific, medical and regulatory (both in U.S. and Europe) authorities.
• Developing and maintaining relationships with academic investigators, pharmaceutical partners/sponsors (current and new), KOL’s, and patient advocacy groups.
• Writing clinical development plans and clinical protocols for new compounds from first-in-man to regulatory approval.
• Maintaining the highest quality clinical programs, following GCP and ICH guidelines. Managing timely reporting of safety signals to regulatory authorities and the generation of clinical study reports.
• Providing clinical information required for IND’s, NDA’s, and other related documents.

Currently, this is an individual contributor role with project management responsibilities in a matrix environment.

Qualifications:

Qualified candidates will have a MD or MD/PhD degree with a minimum of 3 years of experience in oncology clinical development in the industry.  Board certification in oncology is strongly preferred.  Experience in Phase II/III development is highly desirable.  Energy and versatility to work in a pre-commercial biotech setting.  Excellent communication and leadership skills. 

The successful candidate will play an integral role in the development and generation of mouse models of cancer, through the genetic manipulation of embryonic stem cells.  The mouse models are designed to support AVEO’s drug development pipeline. The candidate will learn a wide array of new techniques and cutting edge technologies to assist our growing team and collaborative work environment.

Responsibilities:

• Perform Molecular Biology techniques to support the genetic engineering of mouse lines; including, cloning and mutagenesis of DNA constructs, purification of DNA and RNA from cells and tissues of engineered lines, and analysis by PCR and other methods for gene integration and expression
• Engineer the genome of mice using the most advanced ES cell technology to create mouse models of cancer
• Embryonic stem cell culture, electroporation, and colony picking, propagation, and freezing.
• Assist in derivation of new primary embryonic stems cells
• Perform injections of embryonic stem cells into blastocysts (early mouse embryos) to make chimeric model mice
• Use standard mouse procedures including small animal surgery, embryo transfer, and  colony husbandry
• Assist with genotyping and characterizing of model mice using PCR and flow cytometry (FACS)

Qualifications & Requirements:

• BS/BA in Life Sciences or a related Field and 2+ years of relevant laboratory experience
• Technical expertise will include RNA and DNA hybidization and quantitative RT-PCR, and genotyping DNA and RNA purification and analysis, PCR, and tissue culture.
• Cloning and subcloning of plasmid based DNA constructs
• Experience in generation of mouse models through the manipulation of embryonic stem cells.
• Transgenic technology such as chimera production by blastocysts injection and small animal surgery/embryo transfer is a plus

Reporting to the Chief Medical Officer, the person in this newly created position will create and provide strategic vision, leadership, and management for all activities of medical affairs, including KOL identification and engagement, Medical Science Liaison development and management, publications, medical communications and information, CME sponsorship and oversight of investigator initiated clinical trials. The successful candidate will be that unique individual who combines strategic visionary and tactical operational skills and will build capabilities from the ground up, defining the optimal medical affairs strategy, and execute on that strategy.   Initially this is an individual contributor role with an expectation that the Medical Affairs Group will grow as  product launch nears.

Responsibilities

• Design and implement a world class medical affairs function and infrastructure
• Partner, collaborate, and interface with fellow clinical team members to support our mission to develop great new medicines and make them available to patients in need
• Work collaboratively with Aveo partners on global medical affairs strategies and provide oversight for execution and management of those strategies to meet worldwide needs and to enhance the value of Aveo therapeutics
• Oversee the design and conduct of Phase 3b/4 clinical trials to support the brand strategy and life cycle for Tivozanib, as well as for future products
• Establish and provide senior leadership to medical science liaisons to support product life cycle activities and key messaging
• Create an interactive and compliant drug information function to support post-marketing brand strategies
• Develop and oversee brand publication strategies
• Lead medical review of promotional and advertising strategies and implementation
• Lead corporate strategy and administer external educational grants and continuing medical education support activities
  
  

Qualifications

• M.D. degree or equivalent; board-certified
• Medical expertise in oncology preferred
• Minimum of 10 years of pharmaceutical/biotechnology industry experience, at least 8 of which should be in medical affairs
• Experience building the medical affairs function, or one or more of the key capabilities of medical affairs, from the ground up, is a plus
• Demonstrated success in building effective teams, systems, and processes; proven ability to identify, select and manage a variety of external resources related to execution of medical affairs functions
• Ability to lead a team of functional experts and negotiate the multi-disciplinary environment in which they operate
• Strategic and analytical thinking with the ability to plan and design effective medical affairs brand and life cycle strategies
• Experience and expertise in clinical trial design, interpretation of scientific data, market research, competitive intelligence tools, drug information systems, and medical marketing strategies
• High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a “player/coach” as necessary, and an appetite to lead all activity within the medical affairs functions
• Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills
• Available for domestic and international travel

We are seeking a highly motivated research scientist to join our in vivo pharmacology group which focuses on translational research of novel targeted cancer therapeutics. The successful candidate will join a dynamic team which focuses on utilizing innovative in vivo models tailored to molecular targets for the understanding of mechanisms of action, biomarker discoveries and rational combinations. Areas of responsibilities include establishment and implementation of in vivo models, efficacy assessment, PK/efficacy PK/PD relationship studies, biomarker discovery and development. as well as productive interactions with team members and effective communication across disciplines.

Responsibilities

• Assess pharmacological effects of novel cancer therapeutics through characterization and implementation of traditional and proprietary in vivo cancer models, including subcutaneous and orthotopic models.
• Carry out ex vivo pharmacodynamic studies tailored to the molecular target of interest.
• Working familiarity with histology, IHC and semi-quantification analysis using image analysis tools.
• Maintain proper scientific documentation, analyze, interpret and summarize experimental data.
• Present summaries of results to team members within a group or in a multidisciplinary team-setting.
• Work effectively with team members within a group and across functions.

Qualifications & Requirements

• The successful candidate should possess a BS or MS in biological sciences or related fields with 2+ years of experience in cancer models.  Industry experience with oncology models is strongly preferred.
• Hands-on in vivo skills are required, including experience in formulation, dosing via standard routes, necropsy and sample collection techniques.
• Experience in molecular and cell biology, including  proficiency in general histology, immunohistochemistry Western blotting,, ELISA and qRT-PCR.
• Demonstrated ability to respond and work effectively in a team-oriented environment.
• A track record of successful transitions to new areas and ability to master new techniques/instrumentation.
• High ethical and professional standards, including a commitment to research in a collaborative setting.