Director, Early Development - Clinical Science

<p><strong>About the Role</strong></p> <p>The Director, Early Development - Clinical Sciences will create early development clinical plans, program outlines, study designs and clinical study essential documents. This individual will be accountable for leading the cross-functional Study Teams to meet study deliverables and represent clinical development in core team and investigator meetings as needed.</p> <p>This role will collaborate closely with cross-functional teams such as Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, Finance and Legal to drive efficient and scientifically rigorous early development clinical work.</p> <p><strong>Let’s talk about some of the key responsibilities of the role:</strong></p> <ul> <li>Maintains direct ownership of early development clinical deliverables, actively contributing to protocol development, document authoring, data review, study-level problem solving and execution decisions to ensure scientific rigor and operational excellence.</li> <li>Shape clinical plans including timelines, budgets and oversight of clinical teams.</li> <li>Author and critically review key clinical and regulatory documents, including protocols, SAPs, CSRs, IBs and clinical value dossiers, ensuring scientific rigor, regulatory alignment and quality execution.</li> <li>Lead and oversees the training of study investigators on protocol and on clinical trial procedures.</li> <li>Conduct research to develop foundational education material to inform the early development program strategies.</li> <li>Interpret clinical data and support data-driven decisions.</li> <li>Serve as program lead on early development Core teams, investigator meetings and scientific advisory boards.</li> <li>Engage with internal and external stakeholders, including KOLs and regulators.</li> <li>Exhibits and fosters key leadership competencies, including an innovative mindset, strong business acumen, an outcome-driven orientation, and a commitment to growing and expanding the capabilities and capacity of the team.</li> <li>Collaborate with Clinical Operations, Regulatory Affairs, Translational Sciences, Biostatistics, Medical Affairs and others to ensure robust trial design, scientific and operational alignment and execution .</li> </ul> <p><strong>Factors for Success:</strong></p> <ul> <li>Advanced degree in sciences (e.g. PharmD, MD, PhD) with deep experience in early clinical development</li> <li>Experience in ophthalmology is preferred; dermatology or infectious diseases a plus.</li> <li>Minimum of 10 years of biotech/pharmaceutical clinical development experience, with a minimum of 8 years leadership in clinical trial management experience required</li> <li>Established leaders