Clinical Development Manager - Endocrinology
Basel, CH
Job Purpose
To deliver on the R&D Endocrinology Clinical Development targets and goals, in line with company objectives. The role, reporting to the Head of Global Clinical Development, will support the ongoing activities for the endocrinology pipeline's medications. The position is also responsible for driving a cohesive Recordati policy. Additionally, the role includes the supervision of up to two MDs in clinical development.
Key Responsibilities
- Serve as the medical lead for 2 to 6 assigned clinical development studies in the endocrinology treatment area.
- Assist in the development and execution of the clinical strategy.
- Develop an endorsed Integrated Development Plan (IDP) in line with the Target Product Profile (TPP).
- Contribute to the creation of clinical components for key documents such as Clinical Trial Protocols, Investigator's Brochures, and Clinical Study Reports.
- Act as the medical expert to support registration, market access, commercialization, and the maintenance of product licenses.
- Ensure continuous evaluation of the drug safety profile in collaboration with Pharmacovigilance.
- Support the Business Development department in assessing growth opportunities in endocrinology.
- As the medical expert, support interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders) and internal stakeholders.
- Support the publication and clinical communication strategy.
- Ensure the organization meets industry, regulatory, and Recordati quality standards.
- Ensure good employee working satisfaction and adherence to Recordati policies.
- Ensure the career development of direct reports through performance management, talent review, and succession planning.
Required Education
- A medical doctor with a minimum of 5 years of post-graduate medical education.
- Prior specialization or experience in Endocrinology is preferred
Required Skills and Experience
- A minimum of 7 years of clinical development expertise is required.
- Experience in the management of multi-country projects or studies.
- Thought leader (KOL) management.
- 3rd party vendor management.
Technical Competencies
- Data generation, communication, and medical education.
- Critical analysis of complex clinical data.
- Development of robust, experience-based solutions.
Required Behaviours and Competencies
- Ethical Leadership and Integrity: Champion the highest standards of ethics and transparency, fostering a culture of trust and accountability within the team.
- Collaborative Influence: Lead and inspire cross-functional teams by promoting open communication and shared problem-solving to overcome clinical development challenges and achieve strategic goals.
- Strategic & Operational Acumen: Possess the strategic foresight to define clear objectives, effectively plan activities, and adapt with agility to evolving clinical and regulatory landscapes.
- Stakeholder Engagement: Excel in communicating with a wide range of internal and external stakeholders, including Key Opinion Leaders (KOLs) and regulatory authorities, to build and sustain valuable professional relationships.
- Patient and Business Focus: Maintain an unwavering focus on patient needs while skillfully balancing this priority with the long-term success of the business and the well-being of the team.
Required Languages
Fluent in English