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Adjunct: Perspectives

Akebia Therapeutics

Adjunct: Perspectives

Cambridge, MA
Full Time
Paid
  • Responsibilities

    Reporting to the Head of Research and Development and Chief Medical Officer, the Vice President of Clinical Development will be a member of the Senior Management Team and have ownership over clinical development strategies, plans and oversight/leadership for execution of these plans. This individual will be responsible for building and leading a team of professionals who oversee the medical aspects of all clinical trials. He/she will also lead the clinical pharmacology team. The Clinical Development organization will provide therapeutic area as well as general medical expertise, from high-level protocol development through study conduct, global regulatory submission(s) and product launch.  The VP of Clinical Development will oversee clinical development activities for the marketed product Auryxia, including significant Phase 3b and 4 trials, and the Phase 3, 3b, and 4 development of vadadustat, and for pipeline/in-licensed assets. Vadadustat is an investigational, oral hypoxia-inducible factor prolyl hydroxylase inhibitor, or HIF-PHI, in global Phase 3 development for anemia due to CKD. 

     

    In addition to the above activities the Vice President of Clinical Development will:

     

    • Through effective communication with the project team, senior management, and external stakeholders as needed, establish clear clinical development strategies aligned with corporate goals

    • Ensure execution of strategy and implementation by working closely with members of the Research and Development organization

    • Be responsible for ensuring scientific and medical excellence for clinical programs

    • Provide ongoing scientific and medical expertise to program team(s) regarding disease area and therapeutic agents

    • Establish and/or help to maintain relationships with Key Medical Experts and other external stakeholders

    • Participate in in-licensing activities, including due diligence activities as required

    • Attend key scientific and medical conferences and when required, prepare for and present Akebia program objectives

    • Provide oversight of clinical pharmacology teams and development of plans/execution

    • Provide medical input and oversight during the preparation of various regulatory reports for submission to the health authorities and other stakeholders (e.g., DSUR, IND annual, RMPs, REMS, NDA/MAA, etc.)

    Required Skills Required Experience

    The successful candidate will be a sophisticated and tested leader of teams, with the ability to develop strong relationships cross-functionally.  

     

    • MD required, specialty training preferred, with greater than 12 years industry experience, and a minimum of 8 years leadership experience

    • Demonstrated leadership capabilities including line management responsibilities, effective cross-organizational skills, and proven track record building teams and mentoring individuals

    • Experience with the design and execution of Clinical Development Plans, Phase 1-4 clinical studies including preparation of protocols, Investigator Brochures and other relevant study documents, safety management plans and Statistical Analysis Plans

    • Regulatory agency experience, including submission of briefing documents and presenting at meetings

    • Excellent working knowledge of FDA & ICH/GCP regulations and guidelines

    • Excellent verbal and written communication skills including demonstrated scientific productivity (g., publications, review articles, abstracts)

    • Experience in presenting at investigator meetings, advisory boards and medical and scientific conferences

    • Knowledge and experience working closely with other scientific disciplines within the organization or externally (e.g. discovery/research, non-clinical, clinical pharmacology, regulatory, CMC)

    • Experience conducting and managing trials through contract research organizations (CROs)

    • Independently motivated, detail orientated, with the ability to distill complex issues into actionable solutions

    • Strong interpersonal skills to enable cross function and cross-business success

    • High sense of urgency and commitment to execution with the flexibility and ability to respond to rapidly changing environments and circumstances.

    • Demonstrated high degree of integrity, professionalism, and the ability to establish credibility internally and externally

     

    Akebia is an equal opportunity employer and welcomes all job applicants.  All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

  • Qualifications

    QUALIFICATIONS

     

    To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, ability and/or physical demands required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    KNOWLEDGE/SKILLS/ABILITIES

     

    Ability to communicate effectively in English, both verbally and in writing. 

    Demonstrated ability to handle multiple tasks simultaneously in a fast pace environment.

    Ability to work independently. 

    Strong customer orientation with excellent interpersonal communication skills. 

    Strong analytical and problem solving skills. 

    Detail oriented with excellent organizational skills. 

    Proficient with Word and Excel, and working knowledge of computer operating system.

    Basic knowledge of accounts payable, accounts receivable and maintaining general ledgers is helpful.  Ability to maintain high level of accuracy in preparing and entering financial information. 

    Time management skills. 

    Ability to maintain confidentiality concerning financial files. 

    Be honest and trustworthy; demonstrate strong work ethics. 

     

    CORE COMPETENCIES

     

    • Job Knowledge
    • Work Quality / Work Quantity
    • Customer Focus
    • Initiative / Decision Making / Judgement
    • Communication / Active Listening
    • Accountability / Integrity
    • Interpersonal Skills / Team Oriented / Collaboration
    • Emotional Stability / Adaptability
    • Emotional Intelligence
    • Organization / Time Management
    • Creativity

     

     

    WORKING ENVIRONMENT / PHYSICAL REQUIREMENTS   

     

    Work performed in an office environment. Extensive amount of sitting and using office equipment and computers.  Average mobility to move around an office environment and ability to do some lifting of supplies and materials from time to time.  Working area is in a busy, open area office.  Sensory demands – spends extensive time in intense concentration, entering financial information on a computer which requires attention to detail and high levels of accuracy.  Must meet deadlines.

     

    OTHER DUTIES

     

    Please note this job description is not designated to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.  Duties, responsibilities and activities may change at any time with or without notice.

  • Industry
    Transportation / Trucking / Railroad