Director/Senior, Clinical Research
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 antifibrotic 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.
Role: Clinical Trial Associate, Clinical Operations
The Director/Senior Director, Clinical Research will have responsibility to provide support and clinical oversight for the development plans and oversee the design and execution of clinical trials (Phase 1 to Phase 3) 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 Director/Senior Director, Clinical Research will ensure the clinical development goals and timelines are aligned with the interdisciplinary teams (regulatory, research pre-clinical, medical affairs, precommercial/ commercial), He/she will assist in the development of Blade Therapeutics’ pipeline by thorough assessments of candidates, innovative thinking and active search of opportunities. The Director/Senior Direcotr of Clinical Research will report to the Vice President Clinical Research.
- Participate in all activities in Clinical Development strategy, assisting in designing clinical trials and execution of the clinical and regulatory strategy supporting drug development for drug candidates.
- Provide support and clinical oversight for one or more relevant projects.
- Work with cross functional teams to plan, develop, design and implement Phase 1-3 trials and programs.
- Assist in the analysis and interpretation of the clinical results in the development of Blade Therapeutics pipeline
- Participate in ongoing clinical study team and relevant sub-team meetings, other interactions and communications internally. Interact with research, pre-clinical, pre-commercial/ commercial, regulatory, medical affairs, CMC and other functions to provide input to the clinical development plan.
- Accountable as a medical monitor for one or more clinical trials. Ensure adherence to GCP/ICH standards and internal SOPs in the conduct of clinical trials
- Work with regulatory and other internal partners in completion of regulatory documents and support others with clinical science information.
- Assist with development and implementation of communication with Key Opinion Leaders at advisory boards, major meetings, congresses, publications, other materials.
- Contribute scientific input into the relevant therapeutic disease states for internal and external stakeholders
- Collaborate with internal and external organizations (CROs, clinical and scientific advisors, KOLs, patient advocacy groups, etc.).
- Provide input/leadership to ensure project deliverables are met.
- Provide input/review study start up documents and participate in cross functional data review with other team members (data management, biostats, etc).
- Minimum 4 years relevant experience in research and development within a pharmaceutical or biotechnology industry.
- Clinical development experience across all phases of product development and in multiple therapeutic areas.
- Experience in pulmonology is a plus.
- Proven track record of success in leading and managing teams to design and execute a clinical development plan.
- Experience in design, conduct, analysis, and reporting of clinical studies.
- 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
- An attractive compensation package commensurate with this senior leadership role will be provided
Interested applicants, please send resume to: Marianne Eid
Blade Therapeutics Is An Equal Opportunity Employer