The Medical Director, Clinical and Translational Development is the global clinical leader responsible for clinical programs in autoimmune and degenerative disease indications. Under the guidance of the Senior Director, Clinical Development, the Medical Director will lead a cross functional program team, and is accountable for the design, implementation, and execution of a clinical development program(s) to support decision milestones, regulatory requirements and market access. They will also work closely with Translational and Research teams to support pipeline product development and biomarker strategy. Needs a strong understanding of the compliance framework for clinical development activities and has an innovative drive to help the organization succeed and bring new cures to life.
This position will be based on-site in South San Francisco, CA.
Roles and responsibilities:
- Represents Clinical Development on the Program/Project Team
- Partner with the Project Team Leader to develop and execute the clinical strategy
- Develops the Clinical Development Plan in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval and market access for one or multiple indications
- Leads the creation of clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including IND/CTA and regulatory responses) with high quality and consistency with the CDP.
- Partner with Clinical Operations to provide oversight of trial execution and reach clinical milestones
- Work closely with Translational and Research team to support initiation, execution, and interpretation of data from translational studies
- May act as Medical Monitor, ensuring continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection
- As the medical expert, participates in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g., Clinical Operations, Data Science, Regulatory Affairs, Project Management, Research, Manufacturing, Translational Medicine), and internal decision committees
- Develop and present CRO/CRA/site training materials and present at Investigator Meetings/site initiation visits as required
- May serve as Project Team Leader to strategize and execute a development program under the guidance of the Chief Medical Officer
- Author/review abstracts, posters and manuscripts for publication.
- Travel internationally and domestically up to 15%, as required
Qualifications and Education Requirements:
- MD or equivalent is required
- Advanced clinical training/knowledge or clinical research experience in a medical/scientific area, preferably in gastroenterology
- At least 5 years of experience in clinical research in an academic institution or 3 years in an industry environment required
- Detailed understanding of all aspects of clinical protocol development, implementation, regulatory submissions and overall drug development
- Deep knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the development of study designs is desirable.
- Experience with regulatory submissions and health authorities is required
- Demonstrated ability to establish strong scientific partnership with internal and external key stakeholders
- Demonstrated leadership and strong communication skills with a documented track record of delivering high quality projects/submissions/trials in a global/matrix environment in pharmaceutical or biotech industry or academia or clinical CRO required
- Experience conducting gene or cell therapy clinical trials or prior work in the following indications: inflammatory bowel disease, inflammation, auto-immune disorders, neuroinflammation, or rare/orphan diseases
- Ability to think critically and creatively with a strong attention to detail
- Experience in translational medicine efforts, including use of biomarkers to inform and facilitate clinical development plan