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Sr. Director, Program Management

4 months ago

Emeryville, United States 4D Molecular Therapeutics Full time

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

 

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.  

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators: 

•    Fully integrated clinical-phase company with internal manufacturing
•    Demonstrated ability to move rapidly from idea to IND
•    Five candidate products in the clinic and two declared pre-clinical programs
•    Robust technology and IP foundation, including our TVE and manufacturing platforms
•    Initial product safety and efficacy data substantiates the value of our platforms
•    Opportunities to expand to other indications and modalities within genetic medicine

GENERAL SUMMARY: 

4DMT is seeking a Sr. Director, Program Management to join its Program Management team and ensure the progress and success of the clinical stage assets at 4DMT.

The ideal candidate will successfully leverage their prior drug development experience in complex biologics to partner with Therapeutic Area Heads and Project Team Leaders and the cross-functional teams to effectively drive the clinical development of 4DMT’s therapeutic assets in clinical development.

Experience and a deep understanding of the requirements in all stages of drug development, from discovery to late-stage clinical development, is critical to the success of this role. 

RESPONSIBILITIES:   

Lead cross functional teams to develop and execute upon clinical program strategy, drive strategic and tactical planning, program budget preparation and management as well as prepare accurate program updates for the Executive Team.  Assess the needs of programs alongside Therapeutic Area Heads and Project Team Leader and cross functional team leads to guide operational decisions in effectively advancing 4DMT’s clinical programs  Drive planning for key drug development stage-gate decision points (FIH, regulatory filings, study start-up, etc.)  Identify project risks and proactively facilitate mitigation strategies and resolution.  Ensure relevant communication and alignment across departments, together with internal and external subject matter experts, as appropriate.  Effectively present information, respond to questions, facilitate communications regarding program risks and business impacts the Executive Leadership Team and the Board of Directors, when required.  Support to establish, maintain and enforce best practices, accurate record keeping and implementation of knowledge management databases in collaboration with IT.  Support development, implementation and adherence to operational procedures throughout the organization.  Actively participate in system and process improvements, including documenting policies and procedures to streamline data gathering from all teams for project status reporting.  Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. 

QUALIFICATIONS: 

Education: 

Bachelor’s degree in life sciences or a relevant field. Advanced degree in life sciences preferred. 

Experience: 

15+ years’ experience managing global complex cross-functional programs in the biopharmaceutical industry 6 + years of management experience.  Deep experience managing and leading drug development projects/programs at a pre-clinical and clinical stage within the biopharmaceutical industry is required.  Must have sound knowledge of integrated drug development processes in a biopharmaceutical company. Experience with gene or cell therapy programs preferred.  Experience in ophthalmology, cardiology, or pulmonology therapeutic areas is desirable.  Ability to manage multiple work streams and projects concurrently. Ability to problem-solve, research issues, and propose solutions. Excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly. Team player who leads by example employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve shared objectives.   Project Management Professional (PMP) or other relevant certification is a plus.  Ability to function independently in a fast-paced environment. 

Skills: 

Proficient in the Microsoft suite of programs  MS Project SME OnePage

Compensation range for base salary $265,000/yr - $314,000/yr

Please note: the base salary compensation range and actual salary offered to the final candidate depends on various factors: relevant work experience, skills, and years of experience

  4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.   Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities