Note: The job is a remote job and is open to candidates in USA. EPM Scientific is recruiting for a public late-stage biotech developing receptor antagonist therapies for rare, life-threatening disorders. The Senior Clinical Development Lead will provide strategic leadership and drive end-to-end execution of Phase 1–3 clinical development programs, including trial oversight, protocol development, safety management, regulatory submissions, and cross-functional collaboration.
Responsibilities
- Develop and define short- and long-term objectives aligned with global clinical strategies, and communicate these effectively with clinical staff
- Provide strategic leadership to phase 1-3 development programs and oversee global clinical trials/trial teams on assigned programs
- Lead study protocol development, oversee study execution and final study report development
- Identify and address safety issues reported within assigned programs and develop appropriate mitigation strategies
- Participate in Clinical Team and Operations meetings, including discussion on program budgets and resource allocation
- Evaluate emerging medical and scientific data within therapeutic areas and design clinical strategies to support product development
- Collaborate with cross-functional teams, including nonclinical and business development, to explore new therapeutic targets and indications
- Present at academic congresses, investigator meetings and advisory meetings
- Contribute to regulatory submissions by authoring and reviewing clinical sections of submission dossiers as a medical expert, ensuring alignment with global strategies
- Conduct due diligence by evaluating clinical strategies and development plans of external partners
- Engage with external professional bodies to identify and develop key opinion leaders in assigned therapeutic areas
- Stay current with scientific advancements and provide training and guidance to team members as appropriate
Skills
- MD preferably with a relevant specialization (eg: immunology, hematology, nephrology)
- 5+ years of experience of clinical research, preferably within industry, especially in rare diseases
- Excellent written / oral communication skills. English is company language
- Regulatory experience, especially with successful IND and/or NDA submission experience preferred
Benefits
- Remote - East Coast Preference
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