Vice President, Clinical Research MD
Location: San Francisco, CA
Blade Therapeutics is advancing novel anti-fibrotic therapies to meet important patient needs in an area that has seen little innovation to date. Several rare/orphan and chronic debilitating conditions manifest as a consequence of fibrosis, a complex, pathologic process in which progressive scarring replaces functional tissue. We are seeking to develop therapies to modify disease progression, and in some cases, potentially reverse the fibrotic damage to tissue.
Blade is advancing a risk-diversified product portfolio to address various fibrotic diseases and their underlying pathophysiology. The Company has assembled a critical mass of fibrosis expertise and a top-tier leadership team and world-class network of advisors with unparalleled experience in anti- fibrotic drug R&D. Blade’s founding programs are based on the discoveries of Hal Dietz, M.D., Victor A. McKusick Professor of Genetics and Medicine, Johns Hopkins University, whose pioneering research has elucidated a biological pathway that is enabling the discovery of small molecules to treat and potentially reverse fibrosis.
Blade’s objective is to be the leading anti-fibrotic company with a pipeline of novel therapies designed to address the unmet needs for innovative treatments to treat various fibrotic conditions.
In response to the ongoing pandemic, Blade Therapeutics is evaluating the role of host and SARS- CoV cysteine proteases in viral replication, exacerbation of acute pneumonia, and post-recovery lung dysfunction. In April 2020 Blade Therapeutics initiated a controlled trial of BLD-2660, a Phase 2 ready oral small molecule, to treat COVID-19-related lung disease in hospitalized patients (Clinicaltrials.gov NCT04334460).
Role: Vice President Clinical Research, MD
The Vice President, Clinical Research MD will have responsibility to lead the clinical development team, along with the Senior Vice President, Clinical Development to set the development plans and oversee the design and execution of clinical trials (Phase 1 to Phase 4) and support regulatory submissions.
In collaboration with other development functions and quality assurance, ensure that clinical trials are conducted in accordance with GCP/ICH and regulatory standards.
The Vice President, Clinical Research MD will ensure all interdisciplinary teams (regulatory, research pre- clinical, medical affairs, pre-commercial/ commercial), are aligned with the clinical development goals and timelines and are contributing to its development. He/she will assist in the development of Blade Therapeutics’ pipeline by thorough assessments of candidates, innovative thinking and active search of opportunities.
The Vice President, Clinical Research MD will report to the Senior Vice President, Clinical Development.
- Responsible for designing clinical trials and execution of the clinical and regulatory strategy supporting drug development for early and late-stage drug candidates.
- Responsible for building, managing, and mentoring a clinical team to support clinical development programs.
- Head the Clinical Research Team, coordinating with head of clinical operations, clinical trials managers, clinical trials associates, clinical scientist, medical monitor, biostatistics, data management, clinical supply and medical writing.
- Achieve high quality and on time deliverables.
- Lead the analysis and interpretation of the clinical studies based on the SAP as well as additionally required post hoc analysis
- Assist in the development of Blade Therapeutics pipeline by thorough assessments of in licensing candidates, providing innovative thinking and active search of opportunities
- Interact with research, pre-clinical, pre-commercial/ commercial, regulatory, medical affairs, CMC and other functions to provide input to the clinical development plan.
- Partner with other functions (eg. CMC, Commercial, Medical Affairs, Regulatory Affairs) on the development and refinement of the Target Product Profile and commercialization strategy throughout the product life cycle.
- Ensure adherence to GCP/ICH standards and internal SOPs in the conduct of clinical trials.
- Work with public relations and other team members to prepare publications and presentations for external meetings as well as maintain responsibility for clinical sections of regulatory documents (IB, IND sections).
- 10 years relevant experience in the pharmaceutical or biotechnology industry.
- Broad and extensive clinical development experience across all phases of product development and in multiple therapeutic areas.
- Experience in hepatology is a plus.
- Proven track record of success in leading and managing teams to design and execute a clinical development plan.
- Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines essential, knowledge of ex-US regulatory processes.
- Experience in conducting global clinical trial programs.
- Ability to provide scientific and clinical expertise to a clinical development program and evaluate scientific and clinical strategies to obtain regulatory approval with an entrepreneurial spirit.
- Ability to execute strategies, identify core issues and obstacles for the clinical development of a designated indication and to critically evaluate outside expert advice.
- Demonstrated consistent achievement of team delivery against commitments and goals.
- Strategic thinker and problem-solver capable of identifying risks and risk mitigation strategies.
- Strong teamwork, negotiation and influencing skills, able to work in a team setting and establish clear and consistent goals and objectives.
- Excellent verbal and written communication skills.
- Strong scientific writer and oral presenter.
- “Out of the box” thinker, to take on calculated risks, and champion new ideas and approaches for the advancement of a product portfolio.
- Up to 20% travel may be required.
- MD/DMD/PHD degree with Board Certification
Interested applicants, please send resume to: Marianne Eid
Blade Therapeutics Is An Equal Opportunity Employer