Address
Form of workWe are hiring a Senior Director, Preclinical Programs to lead and advance our in vivo therapeutic program for Hemophilia A. Reporting to the Senior Vice President, Preclinical, this role will be primarily committed to advancing this program to the clinic by applying strong technical leadership and people management skills. In addition, this role will be able to initiate and manage early-stage in vivo programs for other rare inherited diseases.
How you'll contribute
- Reporting to the SVP Preclinical, lead the Hemophilia A gene editing program to a successful IND application
- Partner with CMC, QC, Business Development and the in vivo models team to design and execute IND-enabling studies to meet all regulatory requirements
- Lead interactions with regulatory agencies to support IND study design
- Successfully manage and scale a team of talented scientists and research associates to ensure timely execution and communication of research results with high-quality standards, enabling clear go-no/go decisions and timelines.
- Collaborate with the Chief Medical Officer to understand and plan for clinical translation and establish pre-clinical criteria for development candidate selection
- Present progress updates to key decision-makers, including the executive team, partners, research, and management teams
- Establish scientific standards and set strategic direction and priorities for gene editing strategies
- Collaborate closely with Discovery and Protein Engineering groups to leverage advances in the gene editing platform for future therapeutics
- Provide scientific leadership by proactively advising, sharing knowledge and expert opinions across functions and with senior management
- Work with cross-functional leads to create and execute research strategies
- Anticipate scientific barriers and proactively develops strategies to ensure the successful selection of development candidates
- Oversee the development and execution of assays and studies (efficacy and mechanism of action) to enable the in vivo gene delivery platform and support drug candidate nomination and selection.
- Apply experience and expertise in preclinical development of gene editing drugs to guide in vivo study design.
- Ph.D. in cell/ molecular biology/pharmacology
- Exceptional leadership skills and at least ten years of experience managing senior-level scientists
- Experience in rare inherited diseases with a focus on liver/ metabolic diseases including Hemophilia or other non-malignant hematological disorders
- Demonstrated experience in drug discovery in the gene editing or gene therapy space
- Experience in designing IND enabling studies including toxicology and pharmacology studies
- Successful experience writing/reviewing regulatory sections of IND
- In-depth experience managing CROs to achieve nonclinical milestones on time and within budget
- Comprehensive knowledge of the drug development process, including cross-functional integration from animal preclinical POC through Phase I
- Experience in pharmacokinetics, toxicology, and animal pharmacology/monitoring animal studies
- Experience leading and managing partnerships with biopharma
- A transparent, flexible, can-do approach to address issues innovatively and proactively to promote teamwork and a pleasant work environment.
- Outstanding influencing, oral, and written communication skills.
California Pay Transparency Disclosure:
This position is classified as an exempt position under the Federal Labor Standards Act. The anticipated base salary range for this position will be $250K-$270K. You will also be eligible to receive equity, bonuses, and a full range of medical, financial, and other benefits depending on the position offered. Please note that individual total compensation for this position will be determined at the Company's sole discretion and may vary based on location, skill level, years and depth of relevant experience, and education.
