Vice President, Medical Affairs

Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

Precigen has developed novel manufacturing processes to deliver UltraCAR-T® and AdenoVerse™ immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.

Precigen is advancing an exciting pipeline of novel cell and gene therapy products and to further our efforts we are seeking a Vice President,Medical Affairswho will support clinical and medical assets by the successful execution of clinical development programs and deliverables in partnership across the organization; with external academicians and collaboration partners.

As a leader in the organization, the incumbent will be accountable to jointly develop clinical program strategy and help assure that activities are executed within expected scope, budget and timelines. The Vice President,Medical Affairswill play a key role the establishment and growth of clinical research functions to assure best-in-class global capabilities and execution. This role will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, safety/pharmacovigilance, regulatory, and translational research.

DUTIES AND RESPONSIBILITIES:

• Partner with clinical operations and other functional areas for the successful implementation and execution of clinical studies.
• Provide scientific expertise for selection of investigator and vendors.
• Train colleagues and study site staff on the therapeutic area and/or clinical protocol.
• Provide scientific and medical support throughout conduction of clinical trials; respond to clinical questions from sites, IRBs/IECs, Health Authorities, and CROs.
• Facilitate generation of, author, update, and/or review key documents, including, but not limited to:
  1. Protocol concepts, synopses, protocols, and amendments
  2. Informed consent documents
  3. Investigator Brochures
  4. Clinical study reports
  5. Abstracts, posters and manuscripts
  6. Clinical sections of INDs (and equivalent applications), NDAs (and equivalent applications), Annual Reports, and Developmental Safety Update Reports
  7. Clinical sections of Health Authority Briefing Documents, Orphan Drug applications, and annual reports
  8. Risks / benefits analysis for applicable documents.
  9. Clinical Development Plans
• Review, query, and analyze clinical trial data.
• Interpret, and present clinical trial data both internally and externally.
• Create clinical study or program-related slide decks for internal and external use.
• Build and maintain opinion leader/investigator networks; organize and present at key opinion leader advisory boards and investigator meetings.
• Contribute to or perform therapeutic area/indication research and competitor analysis.
• Build strong relationships with internal experts.
• Identify continuous process improvement opportunities.
• Identify incremental organizational resource needs – staff, budget, and systems.
• Develop, track, execute and report on goals and objectives.
• Be accountable for compliant business practices.
• 30% travel

EDUCATION AND EXPERIENCE:

• MD or PhD with 10+ years of experience within a clinical and/ scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
• Demonstrated experience and success within other biotech/pharmaceutical companies.
• Previous participation in a clinical development program is essential, including involvement in all stages of clinical trials (i.e. from start up to study report), ideally having taken at least one study through from start to finish in a clinical setting.
• Gene and cell therapy experience; candidates with exceptional experience in other therapeutic areas would be considered if they demonstrated clear potential to apply their existing skills to oncology, autoimmune and infectious diseases.
• Expert understanding of global clinical study design and drug development process.
• High level of communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
• Knowledge of GCP and ICH Guidelines.
• Flexibility to work with colleagues in a global setting.
• Able to engage in work-related travel approximately 20% of time.
• Strategic leader with demonstrated success building, managing and developing individuals and teams is preferred.
• Experience with the development and support of related SOPs and policies is expected.
• Knowledge of industry standard Clinical Development IT solutions expected.

DESIRED KEY COMPETENCIES:

• Executive presence; confident, positive attitude, enthusiastic and charismatic.
• Value based collaborator – respectful, accountable and collaborative.
• Self-motivated and independently minded.
• Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
• Self-organizer, meticulous hands-on habits, keen attention to detail.
• Impactful written and verbal scientific communication.
• Successful and superior influencing skills across all levels of the organization and external collaborators.
• Problem solving and risk-mitigation skills.
• Appreciation of diversity and multiculturalism.
• Strategic and creative thinker.
• Ability to build working relations throughout the organization and with business partners to achieve business goals.
• Strong time management and organizational skills.
• Ability to manage multiple projects in a fast-paced environment.
• Skilled in multiple computer-based tools, in addition to software programs such as Word, Project, PowerPoint, Excel, etc.

EOE MFDV

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. We invite you to discover more at www.precigen.com.

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