Vice President / Senior Vice President, Clinical Development Lead - Immunology & Program Leadership

About the role

Flagship Pioneering is committed to developing transformative treatments for patients suffering from serious diseases. We are seeking a highly experienced Vice President or Senior Vice President to take on the leadership role of Clinical Development in the immunology space. This individual will be instrumental in shaping and executing the clinical strategy for multiple innovative therapeutic programs, ensuring alignment with scientific insights, regulatory standards, and patient needs. The successful candidate will work closely with cross-functional teams, including research, translational sciences, regulatory affairs, clinical operations, biometrics, safety, CMC, commercial, and business development, to drive forward our mission of creating impactful medicines. This role offers an exciting opportunity to lead early-stage clinical development efforts, influence organizational strategy, and contribute to the advancement of novel therapies in a dynamic and innovative environment.

Key facts

What you'll do

• Lead the development and implementation of comprehensive clinical strategies for multiple immunology-focused programs, primarily in early phases such as Phase I and II trials.
• Develop detailed clinical development plans that incorporate scientific insights, patient needs, competitive landscape analysis, and company goals, ensuring a clear pathway from discovery to clinical proof of concept.
• Provide expert clinical leadership in designing, executing, and analyzing early-phase trials, including protocol development, dose selection, endpoint determination, and data interpretation.
• Oversee the operational aspects of clinical trials, ensuring adherence to scientific standards, operational excellence, and compliance with regulatory requirements.
• Collaborate with cross-functional teams to identify new indications and opportunities for program expansion, leveraging data and market insights to guide strategic decisions.
• Serve as the Program Team Leader or senior representative, coordinating efforts across functions to meet development milestones, manage budgets, and mitigate risks.
• Lead governance discussions, portfolio assessments, and strategic planning sessions with internal leadership and external partners, ensuring alignment with corporate objectives.
• Work closely with research teams to incorporate translational and biomarker data into clinical development plans, facilitating patient stratification and personalized medicine approaches.
• Analyze clinical, translational, biomarker, and competitive data to inform program direction and optimize trial design.
• Ensure clinical programs are conducted with scientific rigor, operational efficiency, and regulatory compliance, including preparation for regulatory submissions and interactions.
• Maintain a deep understanding of immunology, autoimmune diseases, inflammation, and related therapeutic areas to guide program development and strategic planning.
• Lead efforts to incorporate biomarker strategies and patient stratification techniques into clinical trials, enhancing the precision and efficacy of therapeutic interventions.
• Foster a collaborative environment by working closely with internal teams and external partners to facilitate integrated program execution.
• Proactively identify potential risks and challenges in clinical development and implement mitigation strategies to ensure smooth progress.
• Stay current with evolving regulatory requirements and industry best practices to ensure all clinical activities meet or exceed standards.
• Represent the company at scientific and industry conferences, fostering relationships with key opinion leaders and stakeholders.

Requirements

• MD or MD/PhD with extensive experience in clinical development, particularly within immunology or related therapeutic areas.
• A minimum of 10 years of experience in the biotechnology or pharmaceutical industry, with a proven track record of leading early-stage clinical programs.
• Demonstrated ability to manage cross-functional teams and influence organizational strategy at senior levels.
• Deep understanding of regulatory standards, clinical trial design, and the drug development process.
• Experience in designing and executing Phase I and II clinical trials, including protocol development, data analysis, and interpretation.
• Prior experience with IND submissions and interactions with regulatory agencies is highly desirable.
• Strong leadership skills, with the ability to motivate teams, coordinate multiple projects, and communicate effectively with diverse stakeholders.
• Excellent problem-solving and decision-making abilities, especially in complex, fast-paced environments.
• Familiarity with biomarker development, patient stratification, and translational medicine strategies.
• Ability to operate independently while collaborating effectively within a team-oriented environment.
• Knowledge of ITAR regulations related to sensitive therapeutic areas is a plus.
• Fluency in English, with excellent written and verbal communication skills.

Nice to have

• Experience working in early-stage clinical development and navigating IND submission processes.
• Familiarity with biomarker discovery, validation, and integration into clinical trials.
• Prior work in autoimmune, inflammatory, or immunological diseases.
• Experience with regulatory interactions, including pre-IND meetings and FDA/EMA submissions.
• Knowledge of the biotech industry landscape and competitive environment in immunology.
• Prior exposure to ITAR regulations and handling of sensitive therapeutic data.

Skills & tools

• Strong leadership and team management capabilities.
• Excellent communication skills, with the ability to present complex scientific and clinical data clearly.
• Strategic thinking and problem-solving skills, especially in a rapidly evolving environment.
• Proficiency in clinical trial management systems and data analysis tools.
• Ability to interpret complex clinical and translational data to inform decision-making.
• Effective stakeholder engagement and collaboration skills.
• Adaptability to changing priorities and a fast-paced work environment.

Practical notes

• Visa sponsorship is available for qualified candidates.
• The position offers a competitive benefits package, including health insurance, retirement plans, and paid time off.
• The role is based on-site in Cambridge, MA, and requires working at the office location.
• Applications are accepted on a rolling basis until the position is filled.
• Candidates should be prepared for a comprehensive interview process, including technical assessments and leadership evaluations.