Medical Director, Global Clinical Science, Immunodeficiency (f/m/d), Hybrid

About the Role

Plasma Derived Therapies Business Unit Research and Development (PDT R&D) group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. The Medical Director – Immunodeficiency leads and drives strategy for the overall global (US/EU/Japan/other regions and countries) clinical development for assigned Takeda pipeline compounds in Immunodeficiency. The candidate will apply their clinical expertise development, taking into consideration the medical, scientific, regulatory and commercial perspectives.

Responsibilities

• Leads clinical development for a given product and/or indication and may represent Clinical Science on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.
• Establishes and drives development team strategy and deliverables producing the clinical development strategy, Clinical Development Plan and Clinical Protocols.
• Responsible for high impact global decisions with respect to Immunodeficiency monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development.
• Drives clinical science activities relating to the preparation/approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to associate medical directors and clinical scientists.
• Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.
• Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned products in PDT R&D.
• Responsible for identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and/or in-licensing opportunities. Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda PDT BU R&D’s strategic goals.
• Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned products.
• May hire, manage, mentor, motivate, empower, develop and retain staff to support assigned activities.

In this position you will report to the Head of Primary Immunodeficiency Clinical Science.

Requirements

• M.D. or internationally recognized equivalent degree is required. Additional advanced degree, e.g. Ph.D. is desired.
• Clinical Immunologist or Allergy/Immunology Specialist or Internal Medicine Specialist is preferred.
• 3-5 years of strong clinical research/drug development experience within the pharmaceutical industry is required.
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions is desired.
• NDA/MAA Submission experience is preferred.
• Knowledge/experience in Immunology, or a related specialty, disease mechanisms and plasma derived/related therapies.
• Regional/global Regulatory requirements.
• Management experience is preferred.

Skills

• Superior communication, strategic, interpersonal and negotiating skills.
• Ability to proactively predict issues and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team.
• Diplomacy and positive influencing abilities.

Travel Requirement is approximately 10 - 20%.

Benefits

• Awarded Great Place to Work and certified family-friendly employer.
• Flexible work models: hybrid working and flexible scheduling where possible.
• Career growth & learning: comprehensive development programs, continuous training, mentoring, talent programs, and apprenticeships.
• Internal mobility: opportunities for internal job rotations and cross-functional moves.
• Recognition & rewards: employee referral and recognition programs, plus an employee stock purchase plan.
• Inclusive culture & communities: active participation in employee networks (e.g., Diversity, Equity & Inclusion and Sustainability).
• Employee Assistance Program (EAP): confidential support provided by an external partner.
• Health & wellbeing: wide range of health services, including free vaccinations, psychological counseling, and massages.
• Fitness support: fitness offerings to help you stay active.
• Community & team spirit: company events and celebrations throughout the year.
• Great on-site amenities: company canteen with subsidized prices, Meal Allowances for locations without canteen.
• Family support: company childcare/bilingual on-site daycare (company kindergarten).
• Easy commute: excellent public transport connections.
• Convenient parking: free parking spaces available via booking app.
• Sustainable mobility: company bike leasing program (JobRad).

Pay

U.S. Base Salary Range: $237,200.00 - $372,790.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

U.S. based employees may be eligible for short-term and/or long-term incentives.

Schedule

• Full time.
• U.S. based employees are eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
• U.S. based employees may participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, and company holidays, among others.