Responsibilities
Develop the short- and long-term scientific objectives for the organization covering discovery, development, manufacturing, licensing/approval, and commercialization of product(s) aligned with the company s portfolio.
Provide visionary leadership and strategic direction for the scientific, medical, and regulatory functions, ensuring alignment with the company's overall goals and objectives. Lead regulatory strategy and operations, ensuring compliance with FDA and other relevant regulatory bodies. Oversee the preparation and submission of regulatory filings, including but not limited to INDs, and NDAs.
Develop the strategy for the build out of internal drug discovery capabilities and/or leverage external contract research organizations (CROs).
Oversee all aspects of CMC. ensuring robust processes are in place for product manufacturing and quality control.
Develops and delivers scientific and medical presentations, organizes, and leads medical advisory boards, participates in investigator meetings, provides medical support to commercial team.
Serve as the scientific lead for drug discovery collaborations.
Serve as the scientific due diligence lead for business development activities including search and evaluation, licensing, mergers, and acquisitions.
Oversee and build clinical and medical affairs strategy to support commercialized products and drug candidates in development.
Seek alliances with other science-based organizations; creates and manages effective partnerships that will drive cutting edge ophthalmic treatment for patients.
Represents the company with scientific agencies, globally addressing aspects of the company s research and product development.
Additional responsibilities as assigned.
Qualifications:
15 20 years of relevant experience in the pharmaceutical or biopharmaceutical industry, including 10 years in senior level leadership experience. Prior experience in the field of ophthalmology is required.
MD, PhD, PharmD or similar degree in a life science field from an accredited institution required.
Prior experience building out drug discovery capabilities and overseeing a drug discovery team desired.
Proven track record of successful regulatory submissions and product approvals with the FDA and other regulatory agencies.
Extensive experience in clinical development, regulatory affairs, and CMC/supply chain management.
Strong written and verbal communication skills. Able to effectively communicate concepts and ideas to technical and non-technical audiences.
Effective interpersonal skills. Prior experience with establishing and advancing industry partnerships strongly desired.
Desired experience around due diligence of business development opportunities.
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