Medical Director, Clinical Science, GI2 TAU- Nephrology

About the role

The Medical Director, Clinical Science, GI2 TAU is responsible for leading and driving strategy for the global clinical development of assigned Takeda pipeline compounds. They lead a multi-disciplinary, multi-regional, matrix team through complex decisions and are accountable for high-impact global decisions.

Responsibilities

• Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product.
• Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.
• Recommends scope, complexity and size, and influence the budget of all aspects of a program.
• Maintains a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements.
• Monitors and interprets data from ongoing internal and external studies, assesses the medical and scientific implications, and makes 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 other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies.
• Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
• Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
• Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.
• Identifies and evaluates potential business development opportunities, conducts due diligence evaluations, and develops and negotiates clinical development plans for potential alliances and/or in-licensing opportunities.
• Assesses scientific, medical, and development feasibility, evaluates strategic fit with overall portfolio, evaluates complete or ongoing clinical trials, assesses regulatory interactions and future development plans, interacts with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and represents clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC.
• Leads TGRD internal teams and may lead global cross-functional teams, as appropriate.
• Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.
• Conducts performance reviews and drive goal setting and development planning.

  Requirements

  • MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of the above).
  • Nephrologist preferred.
  • Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
  • NDA/MAA/Submission experience preferred.
  • Management experience.

  Qualifications

  • Therapeutic area knowledge relevant to mechanism of action.
  • Regional/global Regulatory requirements.
  • Emerging research in designated therapeutic area.

  Skills

  • Superior communication, strategic, interpersonal and negotiating skills.
  • Proactive prediction and problem-solving abilities.
  • Drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
  • Diplomacy and positive influencing abilities.

  Benefits

  U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to 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, company holidays, and well-being benefits, among others. U.S. based employees are also 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.

  Pay

  $237,200.00 - $372,790.00

  Schedule

  Hybrid