Associate Medical Director, Clinical Science (Remote)

Location
Working from Home
Posted
May 14, 2022
Ref
4458548004
Required Education
Doctorate/PHD/MD
Position Type
Full time

ASSOCIATE MEDICAL DIRECTOR, CLINICAL SCIENCE (Remote)

Position Summary:

Global Blood Therapeutics, Inc. (GBT) is seeking an experienced clinical scientist/physician, leader and innovative drug developer with passion and creativity and who places the patient at the center of everything they do.

The individual will be a self-starter with excellent, communication (within and outside of the organization) and multi-tasking skills. They should have a strong experience with clinical study conduct, data analysis and health authority document preparation and interactions.

Essential Duties and Responsibilities:

  • Clinical point of contact for all study related matters including clinical study operational conduct, data gathering, analysis and interpretation, safety assessments, regulatory documentation and publications
  • Execution of study related activities in a GCP-compliant manner
  • Clinical lead in communications to senior management and governance committees on study progress and strategic updates
  • Perform responsibilities independently and exhibit proficiency as the Medical Monitor for clinical trials 
  • Support Health Authority document writing, review and interactions, including protocols, CSRs, Information Requests, CTD modules for regulatory filings, Investigator Brochures, pediatric investigational plans, and aggregate reports for pharmacovigilance
  • Provide medical support for allied non-Development functions within the organization, including Business Development, Commercial, Corporate Communications, Medical Affairs, Research, and Technical Operations

Cross-Functional Team Activities

  • Represent Clinical Science in Study Execution Team (SET) Meetings and program sub-teams
  • Participate in Clinical Sub Team (CST) Meetings, contributing study-specific expertise and input
  • Provide clinical leadership to support the training and monitoring of study sites

Clinical Development Planning 

  • Take a leadership role in proposal development to identify effective clinical and regulatory implementation strategies
  • Stay abreast of internal and external clinical and SCD landscape developments and update Clinical Science and other development functional areas
  • Assist in health authority document preparation and interactions
  • Provide clinical input into the relevant therapeutic/disease area scientific strategy
  • Provide clinical input for transitioning new drugs/indications into clinical development

Clinical Development Plan Implementation

  • Provide clinical oversight of relevant studies and progress, including participation in vendor interactions, reviews of medical/safety data, CSR writing
  • Provide clinical leadership for clinical studies, including site feasibility/startup, site interactions, fielding medical questions, clinical monitoring, and conducting Investigator Meetings
  • Represents GBT through collaborations with internal and external partners such as investigators, clinicians, scientists and key opinion leaders
  • Collaborate with Biometrics to ensure appropriate medical/scientific data collection and interpretation for study reporting and health authority interactions
  • Provide clinical science input into annual and strategic lifecycle plans

 Qualifications:

  • MD (or equivalent) preferred; PhD or PharmD acceptable with relevant industry experience in hematology clinical development
  • 7-11+ years of relevant experience
  • Training/board certification in hematology, or industry experience in clinical development of a hematology product strongly desired
  • 2+ years of industry experience, predominantly in a clinical development role, ideally with substantive experience in authoring study protocols, collaborating with thought leaders, data safety monitoring boards, and clinical investigators, starting up clinical trials, medical monitoring, evaluating potential safety signals, and authoring CSRs
  • Some participation in development of regulatory documents, including INDs, NDA/BLAs, Information Requests, and pediatric investigational plans
  • Ability to work independently and in a fast paced, hands-on, growth-oriented work environment

Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.