Exec. Director/Vice President, Clinical Development

Surrozen is a biotechnology company pioneering targeted therapeutics that selectively activate the Wnt Pathway for tissue repair and regeneration.  Surrozen is focusing its Wnt biology expertise and Wnt signal modulation antibody technologies on its ophthalmology programs including development of new treatment options for retinopathies. The Company recently completed a private placement consisting of two tranches in aggregate up to $175 million in gross proceeds to fund multiple ophthalmology programs through initial Phase 1 safety, tolerability and efficacy studies.  Phase 1 studies are expected to commence in 2026.

Modulation of Wnt signaling has the potential to be relevant in a broad range of highly prevalent eye diseases including “wet” and “dry” Age Related Macular Degeneration (AMD), diabetic retinopathy, Fuchs’ endothelial corneal dystrophy (FECD), and non-infectious uveitis as well as certain rare eye diseases like retinitis pigmentosa, Stargardt’s and Familial Exudative Vitreoretinopathy (FEVR). The two lead candidates for the treatment of retinopathies include SZN-8141 (Fzd4/VEGF) and SZN-8143 (Fzd4/VEGF/IL-6). 

SZN-8141 combines Frizzled 4 (Fzd4) agonism and Vascular Endothelial Growth Factor (VEGF) antagonism which has the potential to provide benefits over treatment with single agents for Diabetic Macular Edema (DME) and neovascular Age Related Macular Degeneration (wet AMD). 

SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism which may have benefits over single agents for treatment of DME/wet AMD/uveitic macular edema (UME). 

Reporting directly to the CEO, the Exec. Director/VP Clinical Development will contribute to and lead early clinical programs in ophthalmology and assist in the development of new therapeutic targets. The design and analysis of the clinical programs will involve close collaboration with multidisciplinary teams including preclinical development, biostatistics, clinical operations, quality, regulatory affairs and CMC. As leader of the clinical organization, you will successfully maintain alignment and excellent communications with key stakeholders internally and ably represent Surrozen to Investigators and in public presentations.

Responsibilities

·       Critical team member in establishing the strategic long-term vision for the program(s)

·       Lead development and maintenance of clinical documents (e.g. protocols and amendments, investigator brochures, clinical study reports, informed consent documents, case report forms, etc.) and ensure appropriate medical monitoring for clinical studies

·       Lead clinical study teams and update development staff and upper management on patient recruitment, trial issues, investigator's feedback, patient enrollment issues, and a plan of action for resolution of issues

·       Help identify ophthalmology study sites for Phase 1b/2a studies and foster relationships with study investigators

·       Assist in the preparation of clinical sections of key regulatory documents, including IND annual reports and briefing packages and lead the development of clinical study documents to be used in regulatory interactions and filings

·       Prepare presentation materials for internal and external meetings, such as team meetings, Advisory Boards, and Board of Director Meetings

·       Advise on current and future clinical development plans within internal and joint development teams

·       Maintain state-of-the-art knowledge in relevant therapeutic areas by conducting literature reviews, attending conferences etc. to support clinical development strategies

·       Develop manuscripts, abstracts and presentations for scientific meetings

•        MD or MD/PhD and board certification or training in ophthalmology

•        At least 5 years' experience in the biotech/pharmaceutical industry, with experience in phase 1 and 2 clinical studies in ophthalmology

•        Track record of contribution to successful US IND filings with antibody-based therapies

•        Experience with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, briefing packages and other regulatory submissions

•        Experience interacting with regulatory authorities (e.g. FDA, EMA, etc.)

•        Thorough working knowledge of clinical trial design, methodology, and statistical concepts

•        In-depth knowledge of GCP/ICH guidelines

•        Strong leadership presence and the ability to work effectively with other clinical and scientific leaders

Preferred:

•        Experience managing significant accelerations and/or challenges in clinical programs

•        Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals

•        Is a team player, and works well in a team environment both as a leader and a key contributor

•        Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies

•        Strong communication and organizational skills and ability to interact with a diverse group of individuals

•        Results and detail-oriented; self-motivated, ability to work with minimal supervision

•        Ability to perform in a fast-paced environment

●       We offer a dynamic working environment and a collaborative, passionate team

●       Excellent benefits, including competitive employer contributions

●       Stock options

●       Paid vacation, sick time and holidays

●       Shuttle service to/from Caltrain, BART and the SSF Ferry

●       State of the art research facility complete with bowling alley and onsite gym (amenities available through The Cove