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

7430 Baxalta Innovations • Boston, MA

5d • Hybrid

About The Position

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.

Requirements

• M.D. or internationally recognized equivalent degree is required.
• 3-5 years of strong clinical research/drug development experience within the pharmaceutical industry is required.
• Knowledge/experience in Immunology, or a related specialty, disease mechanisms and plasma derived/related therapies.
• Regional/global Regulatory requirements.
• 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 teams
• Diplomacy and positive influencing abilities

Nice To Haves

• Additional advanced degree, e.g. Ph.D. is desired.
• Clinical Immunologist or Allergy / Immunology Specialist or Internal Medicine Specialist is preferred.
• 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.
• Management experience is preferred.

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 assoc. med 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 and 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 also hire, manage, mentor, motivate, empower, develop and retain staff to support assigned activities.

Benefits

• 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)
• 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
• company holidays
• well-being benefits
• up to 80 hours of sick time
• up to 120 hours of paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Senior