Medical Director - Chicago, IL | Biospace
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Medical Director

Xeris Pharmaceuticals, Inc.

Location:
Chicago, IL
Posted Date:
6/8/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Medical Doctor
Areas of Expertise Desired:

Job Description

Xeris is an emerging pharmaceutical company dedicated to the development of patient-friendly injectable drugs to address important unmet medical needs while improving patient compliance, lowering total costs of treatment, and having a positive impact on patient and caregiver quality of life. With this singular focus on patient quality of life, each member of the Xeris team is working to develop novel products that improve upon existing products or enable delivery of novel drug substances, allowing for treatments not previously possible.

Job Purpose

Xeris is looking for a Medical Director to join our team in Chicago, IL or San Diego, CA.  The Medical Director provides specialist medical strategic and operational input into core medical affairs activities including, interactions with health-care professionals; generation of clinical and scientific data; educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization and safety surveillance activities).  Works closely with clinical development, regulatory affairs, sales, marketing and other internal teams to provide strategic medical input into clinical development plans, regulatory strategy and support medical/marketing activities and market access.  Provides strategic leadership and is responsible for overseeing the development and implementation of the medical and scientific communication platform.  In addition, the Medical Director provides medical input into the long-term vision and growth strategies for Xeris’ product portfolio.

Responsibilities

•   Serve as the in-house medical and scientific expert for Xeris’ product portfolio (glucagon-based and other programs) and support internal colleagues from Research, Clinical Development, CMC, Business Development, Portfolio Planning, Marketing and Sales.
•   Participation in development of hypotheses, rationale and design of Xeris’ clinical research protocols and study reports.
•   Participation in design and execution of clinical trial safety, post-marketing surveillance, product safety and risk management plans.  May also carry responsibility for safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events and Serious Adverse Events from clinical studies as assigned.
•   Participate in the conduct of clinical trials and is medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.  
•   Develop and maintain relationships with national external experts and through Professional and Patient Advocacy Associations, Professional Meetings and Conferences, etc. in support of common scientific objectives.
•   Seek input and alignment with key internal stakeholders on Medical Affairs initiatives (e.g, research gap analysis, communication plans, novel indications, etc.)
•   Manage the budget for the specific Cost Center as assigned and provide direction and oversight for the overall Medical Affairs budget.
•   Provide medical and scientific direction and review for pre and post launch regulatory strategies (which may include label (PI), protocols, NDAs and Supplemental NDA’s, etc)
•   Either directly, or indirectly through supervision, oversee the medical review and sign-off of promotional pieces in support of the Medical-Regulatory-Legal committee.
•   Participate in the publications strategy by providing scientific and publication planning input, including review and sign-off of materials for medical/scientific presentations and publications.
•   Interact internally with senior level management to inform corporate strategy and provide decision-support.
•   Participate in external alliances and partnerships to help foster Xeris’ corporate objectives.
•   Provide support for departmental initiatives and other duties as assigned.

Requirements

•   Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with current or recent board certification in internal medicine and/or endocrinology.
•   Maintain minimum standards of education/certification in individual professional discipline.
•   Minimum 5 years of clinical trial experience in the biotech/ pharmaceutical industry or academia or equivalent combination of experience.  7+ years of experience is preferred.
•   Experience in Medical Affairs including clinical research, medical communications, publication activities, congress presentations and interactions with professional and patient advocacy organizations.
•   Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials, experience in development strategy and the design of protocols.
•   Up-to-date knowledge of FDA, OIG, PhRMA, ICMJE (GPP3) and ACCME guidelines.
•   Proven leadership skills in a cross-functional team environment.  
•   Ability to interact externally and internally to support corporate business strategy.
•   Must possess excellent oral and written communication skills.
•   Some domestic and international travel may be required (up to 25%)

Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law.  It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.