Senior Director, Clinical Development
Scorpion Therapeutics, San Francisco, California, United States, 94199
Role Summary
The Senior Director of Clinical Development will serve as a key leader in driving the clinical strategy and execution of one or more development programs, from Phase I through Phase III, ensuring scientific integrity and regulatory compliance. The role involves end-to-end design and execution of clinical programs, collaboration with cross-functional teams, leading regulatory submissions, and establishing partnerships with key opinion leaders and external stakeholders. Location: Brisbane, California (preference for candidates in the San Francisco Bay Area).
Responsibilities
Lead the strategic direction and execution of clinical development programs, from early-phase through late-stage clinical trials ensuring they are scientifically robust and meet regulatory requirement.
Collaborate cross-functionally with teams in clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics to ensure the successful execution of clinical development plans.
Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, and study protocols, ensuring alignment with global regulatory guidelines (FDA, EMA).
Analyze, interpret, and communicate clinical trial data to inform key decisions, providing clear recommendations to guide clinical development strategy.
Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives.
Manage clinical trial budgets, timelines, and resources, ensuring the delivery of high-quality results aligned with corporate objectives.
Regularly present clinical progress, data outcomes, and strategic recommendations to executive leadership, stakeholders, and external partners.
Stay at the forefront of industry trends, scientific advancements, and regulatory developments to ensure the company remains competitive in clinical development strategies.
Identify potential risks in clinical development timelines, budgets, or regulatory pathways, and develop contingency plans to mitigate them.
Qualifications
Required: MD or PhD in Neurology, Neuroscience, or a related field.
Required: Over 10 years of experience in clinical development, with a focus on CNS-related indications.
Required: Proven leadership in designing, managing, and executing clinical trials from early phase through late-stage development.
Required: Demonstrated experience in leading clinical development teams at a senior or executive level, ideally within a high-growth biotech or pharmaceutical environment.
Required: In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA) and clinical development processes, including experience in HA meetings, writing briefing books, attending/supporting meetings.
Required: Exceptional leadership, strategic thinking, and communication skills with a proven ability to influence across functions and levels.
Required: Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.
Required: Strong analytical and problem-solving skills, with a data-driven approach to decision making.
Required: Demonstrated success in building collaborations with cross-functional teams and external partners in a dynamic, fast-paced environment.
Preferred: Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting.
Preferred: Familiarity with emerging trends in neurology, including cutting-edge therapeutic modalities.
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Responsibilities
Lead the strategic direction and execution of clinical development programs, from early-phase through late-stage clinical trials ensuring they are scientifically robust and meet regulatory requirement.
Collaborate cross-functionally with teams in clinical operations, regulatory affairs, medical affairs, pharmacovigilance, and biostatistics to ensure the successful execution of clinical development plans.
Drive the preparation, submission, and management of regulatory filings, including clinical trial applications, investigator brochures, and study protocols, ensuring alignment with global regulatory guidelines (FDA, EMA).
Analyze, interpret, and communicate clinical trial data to inform key decisions, providing clear recommendations to guide clinical development strategy.
Establish and maintain strategic relationships with key opinion leaders (KOLs), clinical investigators, and external stakeholders to advance clinical initiatives.
Manage clinical trial budgets, timelines, and resources, ensuring the delivery of high-quality results aligned with corporate objectives.
Regularly present clinical progress, data outcomes, and strategic recommendations to executive leadership, stakeholders, and external partners.
Stay at the forefront of industry trends, scientific advancements, and regulatory developments to ensure the company remains competitive in clinical development strategies.
Identify potential risks in clinical development timelines, budgets, or regulatory pathways, and develop contingency plans to mitigate them.
Qualifications
Required: MD or PhD in Neurology, Neuroscience, or a related field.
Required: Over 10 years of experience in clinical development, with a focus on CNS-related indications.
Required: Proven leadership in designing, managing, and executing clinical trials from early phase through late-stage development.
Required: Demonstrated experience in leading clinical development teams at a senior or executive level, ideally within a high-growth biotech or pharmaceutical environment.
Required: In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA) and clinical development processes, including experience in HA meetings, writing briefing books, attending/supporting meetings.
Required: Exceptional leadership, strategic thinking, and communication skills with a proven ability to influence across functions and levels.
Required: Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.
Required: Strong analytical and problem-solving skills, with a data-driven approach to decision making.
Required: Demonstrated success in building collaborations with cross-functional teams and external partners in a dynamic, fast-paced environment.
Preferred: Experience with regulatory submissions and clinical trial oversight in a biotech or pharmaceutical setting.
Preferred: Familiarity with emerging trends in neurology, including cutting-edge therapeutic modalities.
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