What are the responsibilities and job description for the Associate Medical Director position at Xeris Pharmaceuticals, Inc.?
Overview
The Associate Medical Director will act as the Medical Monitor for Xeris clinical trials, collaborating with cross-functional study teams on clinical trial strategy, design and execution. In this role, the individual will oversee study conduct and safety monitoring for assigned trials, spanning Phases 1 through 3, and may also contribute to selected projects across multiple clinical development programs.
Responsibilities
- Provides project physician support to clinical study teams during the execution of clinical research studies, including but not limited to protocol development, electronic Case Report Form (eCRF) development, therapeutic area training, protocol queries, patient eligibility determination, clinical/safety data review, and clinical summary report generation.
- Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution.
- Contributes to the preparation of regulatory documents in support of regulatory submissions, including but not limited to clinical section of Investigational New Drug’s (IND) application and Clinical Trial Agreement (CTA), IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/Institutional Review Boards , and other documents as appropriate.
- Provides scientific and clinical input to study-related documents and analysis plans [e.g. informed consent forms (ICF), statistical analysis plans (SAP), clinical study reports (CSR)].
- Performs other duties as assigned related to other aspects of Clinical Research.
- Represents Xeris at clinical sites during studies and in external reporting of study results.
- Up to 30% global travel
Qualifications
- Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment.
- Board certification/eligibility Internal Medicine, Endocrinology or another relevant medical field, is highly desired
- Ability to run a clinical research study with minimal supervision
- Clinical trial experience in the pharmaceutical industry, academia, or equivalent is desired
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials
- Excellent oral and written communication skills
- Ability to work collaboratively in a fast moving, team-based matrix environment and to function independently as appropriate
- This is a hybrid position based in Xeris’ Chicago office and a minimum of three days per week on-site is required. On-site requirements may change at management’s discretion.
The level of the position will be determined based on the selected candidate’s qualifications and experience.
#LI-HYBRID
As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, 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.
The anticipated base salary range for this position is $200,000 to $260,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Salary : $200,000 - $260,000
