Global Clinical Strategy Lead

1 month ago

Bengaluru, India Viatris Full time

At VIATRIS, we believe healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

  • Access – Providing high quality trusted medicines regardless of geography or circumstance;
  • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
  • Partnership – Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how this role will make an impact:


POSITION PURPOSE

A brief summary of the purpose this position must fulfill.

Global Clinical Strategy Lead (GCSL) is a strategic role with in the Global Clinical Strategy and Innovation Department, which is primarily responsible for review and evaluation of external and internal product opportunities from a clinical strategy and development perspective in collaboration with cross functional departments. The person will provide medical and strategic leadership in identification, evaluation, and clinical due diligence of differentiated and novel products in the assigned therapeutic area. GCSL will also be responsible for providing clinical strategic program leadership for the clinical development of assigned products. This position will lead a highly matrixed organization to establish, develop and execute robust clinical development programs in assigned therapeutic areas across various verticals. This role works collaboratively with Global Business Development (GBD), Portfolio, Global Commercial Development (GCD), Global and Regional Medical Affairs, Global Clinical Operation Leads, Biometrics, Regulatory Affairs, Development Program Leaders, PK-DM Scientists, Vertical R&D Leaders, and other key internal stakeholders to achieve the goals of the organization. Ensures compliance with the Standard Operating Procedures (SOPs), current Good Clinical Practices (GCP), and regulatory requirements.


ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Identification and evaluation of product opportunities developed internally or externally in the assigned therapeutic area
  • Supports or leads multidisciplinary teams in assessing potential product opportunities, driving an integrated approach for the review, evaluation and recommendation for the clinical part of global (and regional or local as applicable) product evaluation
  • Provide medical and clinical development expertise for the evaluation of internal and external R&D opportunities
  • Responsible for the assessment of the appropriateness of clinical development plans suggested by partners or developing clinical development plans (including budget and timelines) for in-licensing deals under consideration. Responsible for the evaluation of products from clinical regulatory requirements based on the prevailing regulatory guidance and clinical best practices
  • Works closely with Global BD, Global Commercial Development and Global R&D to support business cases by providing information on TPP, product positioning, competitive landscape, clinical development milestones, costs and probability of technical success.
  • Maintains a strong network of subject matter experts within the organization across functions and key opinion leaders outside the organization to get insights for product evaluations and assigned clinical development programs
  • Integrate scientific rationale, regulatory requirements, target product profile, product development plan and commercial goals to build and optimize a clinical development plan (CDP) and gain approval from internal and external stakeholders
  • Generate estimates for cost and timelines to execute the CDP with the support from global clinical operations (GCO). Estimate the probability of clinical development success for the calculation of overall PTRS (probability of technical and regulatory success). Incorporate key decision points and clinical criteria for Go-No-Go decisions.
  • Serve as Clinical Sciences Study Lead (CSSL) for the assigned clinical development programs. Plans, designs and oversees clinical programs as required throughout all stages of drug development with operational assistance from a clinical operations team and program management team. Accountable for clinical protocol and study report content. With clinical team, tracks emerging clinical profile of the drug, keeps line management informed of changes in the profile as they occur. Must be fully knowledgeable about the clinical profile of programs on which studies are being conducted or which are called for in the protocol.
  • Leads other team members in the data review, analysis and reporting of assigned clinical studies, with responsibility for overall content and accuracy of study report and final sign-off.
  • Serve as the Sponsor Medical Monitor (MM) for clinical trials, to address patient eligibility and protocol questions in cooperation with the contract research organization (CRO) MM. Conducts a periodic clinical oversight of assigned clinical development programs as per the Standard Operating Procedures (SOP).
  • Clinical contributions to all regulatory documents including Investigator Brochures, regulatory advice meetings, NDA/MAA. Leads the resolution of clinical queries from drug regulatory agencies, takes a lead role in reviewing responses to regulatory queries.
  • Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct, including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource in terms of both medical background and clinical trial design.
  • Ability to produce and present quality scientific papers at external meetings and for publication. With line management endorsement, manage and initiate external collaborations with world leading clinical experts to forward clinical science in assigned therapeutic area.


QUALIFICATIONS

EDUCATION/EXPERIENCE

  • Medical degree along with post-graduate training like MD/MBA/PhD and 5 to 10 years of relevant clinical development, clinical strategy or clinical due diligence experience. However a combination of experience and/or education will be taken into consideration.
  • Must set a vision for the successful clinical progression of drug candidates and inspire others to excel and constantly strive to succeed.
  • Constantly challenges existing paradigms in clinical research and encourages use of breakthrough designs based on an understanding of clinical methods, biomarkers and new technologies

LICENSES/CERTIFICATIONS

  • Licensed medical practitioner desired
  • MBBS+MD is Mandatory

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Normal office situation. Periodic travel is required.

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