Global Blood Therapeutics, Inc. (GBT) is a clinical-stage biopharmaceutical dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developing its lead product candidate, GBT440, for the treatment of sickle cell disease and idiopathic pulmonary fibrosis.
We are passionate and committed to developing our product candidate GBT440, an oral, once-daily therapy that is designed to modulate hemoglobin affinity for oxygen. GBT440 has the potential to treat sickle cell disease and improve hypoxemia in idiopathic pulmonary fibrosis.
The Senior Manager of Regulatory Affairs will provide leadership on global clinical regulatory activities for GBT compounds for the treatment of sickle cell disease (SCD). Responsibility will mainly focus on clinical regulatory filings and providing strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and NDA submissions activities, as well as international submission activities, for the product candidates.
Essential Duties and Responsibilities:
Provide interpretation of regulatory authorities’ feedback, policies and guidelines to GBT personnel
Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of clinical submissions required for regulatory approval
Work with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained
Responsible for filing of IND/CTA and contribute and/or lead NDA/MAA submission activities. Interacts with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions
Effectively plan, organize, and conduct in close collaboration with leads from other functional areas. Assure compliance with project team timelines and milestones
Provide organizational support and be prepared to manage personnel as company grows its product development pipeline
Bachelor’s degree in a Life Sciences discipline or equivalent, advanced degree preferred
Must have 5 to 8 years of biopharmaceutical experience, and at least 5 years of hands-on regulatory affairs and successful IND and NDA/MAA submission experience
Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills
Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus
Demonstrated excellence in regulatory liaison/strategy
Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams
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
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.
Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
Global Blood Therapeutics (GBT, www.globalbloodtx.com), based in South San Francisco, is a clinical stage biopharmaceutical company developing novel small molecule therapeutics to treat grievous, non-malignant blood-based conditions for which there are currently only limited therapy.
GBT440, the company’s lead drug candidate, is a potential once daily oral prophylactic therapy for patients ...with sickle cell disease (SCD). By disrupting the fundamental pathophysiology of SCD, GBT440 has the potential to halt red blood cell sickling and disease progression, which could fundamentally transform the lives of SCD patients. A Phase I/II study is ongoing; proof of concept was demonstrated in August 2015 which was the basis of the company’s IPO.
GBT has a pipeline of research programs addressing additional important blood disorders. The company is currently identifying small molecule leads for an orally administered prophylactic treatment of angioedema attacks. Additionally, GBT scientists are developing novel hemoglobin modifiers for pulmonary disorders in which increased oxygen delivery is needed (e.g. acute respiratory distress syndrome). GBT’s R&D programs have been discovered internally based on combining our extensive expertise and capabilities in blood biology, medicinal chemistry and structural biology.
GBT was launched in 2012 with $41 million in funding from leading healthcare investor Third Rock Ventures. In December 2014, the company completed a $48 million Series B financing. The company completed its initial public offering on August 11, 2015 with proceeds of over $120 million.
Our Core Values:
* Science dedicated to patients
* Embrace open communication and debate
* Trust, respect, and accountability
* One team, one purpose
...always do the right thing