As a key leader, this individual will guide clinical asset and disease strategies, ensuring projects are completed on time, within budget, and in line with organizational goals.
The Executive Director will also play a vital role in shaping and expanding the Clinical Development department by recruiting, mentoring, and developing team members.
The role involves working closely with clinical investigators, key opinion leaders (KOLs), scientists, and multidisciplinary internal groups, such as regulatory, research, legal, business development, and commercial teams.
Responsibilities: Act as a key contributor in shaping clinical development strategy, presenting recommendations to internal governance committees.
Lead and provide clinical oversight for all assigned studies, taking accountability for the execution and progress of clinical programs.
Collaborate with regulatory teams to complete and submit regulatory filings and documentation.
Offer scientific and clinical expertise to support regulatory submissions and other related activities.
Lead communication strategies for ongoing and completed studies, engaging with KOLs, advisory boards, and attending major medical meetings and conferences.
Contribute clinical insights to the broader scientific strategy within relevant therapeutic or disease areas.
Identify resource needs, including staffing, processes, and technology to support clinical development efforts.
Mentor and coach team members, guiding their professional development and growth.
Uphold leadership values and act as a mentor, fostering a strong and motivated team.
Qualifications: Minimum of 8 years, with preference for 10+ years, of experience in biotech, pharmaceuticals, or related academic fields.
Advanced medical degree (MD or equivalent) with specialized training in hematology or oncology.
Extensive knowledge of the scientific and development processes required to turn a research asset into a therapeutic product.
Ability to translate complex scientific information into commercially viable plans.
Strong written, verbal communication, organizational, and cross-functional collaboration skills.
Proven experience in leading study start-up, overseeing clinical execution, managing regulatory interactions, and guiding teams through data cleaning, medical review, and database locks.
Strong leadership skills, with a focus on building highly effective teams both cross-functionally and externally.
Demonstrated ability to develop high-potential team members into future leadership roles.