Vice President, Clinical Research MD
Location: San Francisco, CA
Blade Therapeutics (“Blade”) is a private biopharmaceutical company founded on a commitment to revolutionize the treatment of debilitating, incurable fibrotic diseases that impact millions of people worldwide. The Company is an expert in novel biological pathways – including autotaxin / lysophosphatidic acid (LPA) and calpain biology – that are foundational to cell and tissue damage responses leading to fibrosis. Blade is advancing a robust pipeline of potential first-in-class investigational therapies for diseases of lung, liver and heart fibrosis, as well as neurodegenerative diseases.
Blade is advancing a robust pipeline of potential first-in-class investigational small-molecule therapies to combat diseases of lung, liver and heart fibrosis, as well as neuro-degenerative conditions. This pipeline includes multiple direct inhibitors of autotaxin / LPA and of dimeric calpainsthat offer distinct but complementary anti-fibrotic mechanisms.
The Company has assembled critical leadership expertise supplemented by a world-class network of scientific, pharmaceutical and clinical advisors to enable efficient and successful drug development. Since the company’s founding in 2015, Blade has used a combination of in-house drug research and selective in-licensing to build a risk-diversified pipeline. Our focused approach offers tremendous opportunity to produce disease-modifying, life-saving therapies.
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