Clinical Development & Operations

Role Summary:

The Clinical & Medical role will lead the clinical development and medical strategy for the organization's portfolio, ensuring alignment with business goals and regulatory standards. This role is responsible for overseeing clinical trials, medical affairs, regulatory submissions, and stakeholder engagement, as well as providing scientific leadership across all therapeutic areas. The individual will collaborate closely with internal and external stakeholders to drive the success of clinical programs, ensure patient safety, and promote the organization's vision for innovative healthcare solutions.

Key Responsibilities:

Clinical Development & Medical Strategy:

Lead the design, execution, and management of clinical development programs from early- phase to late-stage trials, ensuring alignment with the organization's strategic goals.

Develop and execute clinical development plans for new therapies and products, including protocol design, patient recruitment strategies, and study management.

Work with cross-functional teams (R&D, regulatory, commercial) to integrate clinical insights into overall development strategies.

Ensure clinical trials meet regulatory standards (FDA, EMA, ICH-GCP) and are conducted efficiently within budget and timelines.

Provide medical and scientific oversight for clinical trials, ensuring patient safety and scientific integrity.

Lead the development of medical strategies and communication plans to support product approvals and commercial launches.

Engage with key opinion leaders (KOLs), investigators, and external partners to build relationships and maintain scientific excellence.

Develop clinical presentations, abstracts, and publications to showcase clinical outcomes at scientific conferences and in peer-reviewed journals.

Clinical Operations Management:

Oversee global clinical trials, including protocol development, site selection, patient recruitment, and data analysis.

Manage CROs, investigators, third-party laboratories, and other stakeholders to ensure adherence to timelines and protocols.

Implement risk management strategies to address trial challenges and maintain successful trial execution.

Monitor clinical performance through audits, reviews, and feedback, ensuring corrective actions are taken as necessary.

Regulatory Compliance Safety:

Collaborate with regulatory affairs to support clinical trial applications (IND, CTA) and ensure compliance with global regulatory requirements.

Provide input on regulatory submissions, including clinical study reports, safety reports, and product labeling.

Monitor patient safety throughout clinical trials, overseeing adverse event reporting and safety management procedures.

Stakeholder Engagement:

Serve as the primary point of contact for internal and external stakeholders on clinical and medical matters, providing updates to senior leadership, regulatory agencies, and key partners.

Develop and maintain strong relationships with KOLs, investigators, CROs, and healthcare professionals in relevant therapeutic areas.

Represent the organization at national and international scientific meetings, presenting clinical outcomes and engaging with the scientific community.

Team Leadership and Development:

Lead and mentor the clinical development and operations team, fostering a culture of scientific excellence, collaboration, and continuous improvement.

Ensure team members are trained in best practices for clinical development, compliance, and regulatory requirements.

Promote innovation within the team, identifying opportunities for process improvements and implementing best practices in clinical and medical operations.

Budget and Resource Management:

Manage clinical and medical budgets, ensuring efficient allocation of resources and cost- effective trial execution.

Collaborate with finance and operations teams to forecast clinical development costs and allocate resources accordingly.

Primary Objectives:

Clinical Development & Medical Strategy

Clinical Operations Management

Regulatory Compliance Safety

Stakeholder Engagement

Team Leadership and Development

Budget and Resource Management

Competencies Required:

Technical Competencies:

o Strategic leadership and vision with the ability to drive clinical and medical strategies. o Exceptional communication and stakeholder management skills.

o Expertise in clinical trial design, regulatory compliance, and safety monitoring.

o Ability to manage multiple projects simultaneously and work in a fast-paced, dynamic

environment.

o Strong analytical skills, with the ability to interpret and present complex clinical data. o Experience in clinical trials, teaching, training, public speaking, presenting papers & publications

Soft Skills:

High motivation to create impact, Ability to drive results.

Understanding of clinical trial applications

Strategic thinking and problem-solving

Qualifications:

MD or a related medical discipline.

Clinician preferably haemato-oncologist

10+ years of clinical and medical experience in the biotechnology, pharmaceutical, or healthcare industry.

Proven track record of leading clinical development programs from Phase I to Phase III and beyond.

Strong knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and healthcare industry standards.

Working Conditions:

Role Type: Full Time and Onsite

Work Hours: 9:00 AM to 6:00 PM for the General Shift

Travel Requirements: Depends