Medical Director, Clinical Science, Inflammation TAU
About The Position
The Medical Director, Clinical Science, provides medical and scientific leadership for a global development program within Takeda’s Inflammation Therapeutic Area. The role contributes to clinical strategy and study execution, including study design, protocol development, medical monitoring and safety oversight, clinical data review and interpretation, and preparation of clinical and regulatory documents. The Medical Director works with cross-functional partners and provides medical input in interactions with investigators, external experts, and regulatory authorities. The position represents Clinical Science on project or clinical teams and may lead the Clinical Science function on those teams. It supports alignment between clinical activities and global strategy, contributes to the Clinical Development Plan and overall asset strategy, and leads the development of protocols and other documents needed for study execution and regulatory submissions. The role evaluates development strategies and study data, identifies challenges and contingency plans, and recommends high-impact global decisions, including decisions that may affect development plans, study designs, timelines, or product labeling. The Medical Director oversees clinical science activities related to synopsis and protocol approval and study conduct, advises other clinical scientists, and is accountable for the design and interpretation of clinical studies. Responsibilities also include presenting study conclusions to management, evaluating medical significance for patients, medical monitoring and safety assessment in conjunction with Pharmacovigilance, and making final study-conduct decisions related to scientific integrity. The role directs interactions with key opinion leaders, incorporates their advice into clinical programs as appropriate, and develops company positions and materials for research programs and regulatory interactions. The position evaluates potential business development opportunities through scientific, medical, and development due diligence; works with partners on ongoing alliance projects; interacts with the research division; and represents Clinical Science on high-impact task forces. It also hires, manages, mentors, motivates, develops, and retains staff. The position is classified as hybrid and requires approximately 15–25% travel, including possible overnight and international trips.
Requirements
- MD or internationally recognized equivalent.
- At least 2 years of clinical research experience in the pharmaceutical industry, a CRO, a health-related consulting company, or biomedical/clinical experience within academia, or a combination of these.
- Superior communication, strategic, interpersonal, and negotiating skills.
- Ability to proactively predict issues and solve problems.
- Ability to drive decision-making in multidisciplinary, multiregional matrix teams.
- Diplomacy and positive influencing abilities.
- Knowledge of therapeutic areas relevant to the mechanisms of action of compounds in remit.
- Knowledge of regional and global regulatory requirements.
- Knowledge of GCP/ICH.
- Knowledge of emerging research in the designated therapeutic area.
- Ability to drive or fly to meetings or client sites, including overnight trips; some international travel may be required.
Nice To Haves
- Clinical or industry experience in Nephrology or Immunology.
- Previous experience successfully leading matrix teams.
- Management experience.
Responsibilities
- Represent Clinical Science on project or clinical teams and potentially serve as the Clinical Science leader.
- Support the Global Project Team in aligning clinical team activities with global strategy.
- Contribute to the asset strategy and Clinical Development Plan; lead development of clinical protocols and other documents for study execution and regulatory submissions.
- Recommend study scope, complexity, and size, and influence study budgets.
- Continuously evaluate development strategies, identify challenges, and develop contingency plans.
- Recommend high-impact global decisions.
- Monitor and interpret internal and external study data; assess medical and scientific implications and recommend development, study-design, or go/no-go decisions.
- Oversee preparation and approval of synopses and protocols and conduct of clinical studies; advise other clinical scientists and ensure successful study design and interpretation.
- Present study conclusions to management and determine their impact on compound strategy.
- Interpret data from scientific and patient-level medical perspectives.
- Conduct medical monitoring and assess protocol-conduct issues and individual subject safety.
- Assess overall study and compound safety information with Pharmacovigilance.
- Oversee non-medical clinical scientists in assessment of study and safety issues.
- Make final decisions on study conduct related to scientific integrity.
- Direct interactions with key opinion leaders and lead meetings and negotiations relevant to assigned compounds and therapeutic areas.
- Lead development of company-position documents, meeting materials, and formal responses to regulatory organizations or opinion leaders.
- Incorporate appropriate advice and recommendations into clinical study and program designs.
- Evaluate potential business development opportunities and conduct scientific, medical, and development due diligence.
- Interface with partners on ongoing alliance projects to achieve Takeda’s strategic goals while maintaining effective working relationships.
- Interact with the research division using relevant clinical and development expertise.
- Represent Clinical Science on high-impact or high-priority internal and external task forces.
- Hire, manage, mentor, motivate, empower, develop, and retain staff.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
