Title Senior Manager Clinical Development Onco

Senior Manager Clinical Development Onco

ID: 2569

Date of Posting: May 18, 2026

Business Area: Research & Development

Job Type: Direct Employee

Territory:

Full-Time or Part-Time: Full Time

Seniority: Mid-senior

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.

We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.

At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.

This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.

Recordati. Unlocking the full potential of life.

Job Purpose

• Provide comprehensive medical and scientific leadership to the design, set‑up, execution and conduct of planned and ongoing clinical trials, from protocol development to study closure and Regulatory submission.
• Support program and portfolio goals; may participate in the preparation of the Clinical Development Plans, based on the strategy agreed with the cross‑functional Team.
• Ensure that development strategies, trial designs, and execution plans are scientifically sound, operationally practical, and compliant with GCP standards and Regulatory expectations.
• Act as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials.
• Establish and maintain excellent partnership with the medical/scientific community and Key Opinion Leaders, as well as with Patient Associations.
• Collaborate effectively with Clinical Pharmacology, Clinical Operations and Biostatistics to inform protocol design, amendments, and Regulatory interactions.
• Provide medical/clinical support to the Business Development Team.

Key Responsibilities

• Act as the medical expert to ensure that clinical trial designs, endpoints, and assessments are fit‑for‑purpose in rare disease settings, scientifically rigorous, and operationally feasible.
• Lead the clinical components of key clinical trial documents, including clinical trial protocols and amendments, Investigator’s Brochures and updates, Informed Consent Forms, Medical Monitoring Plans, Safety Monitoring Plans, and statistical analysis plans.
• Act as Medical Monitor to ensure continuous evaluation of clinical and safety data; provide medical support to investigators and CROs.
• Maintain end‑to‑end medical oversight of trial execution in close partnership with internal functions and external stakeholders.
• Ensure that the necessary regulatory, safety and data evaluation requirements are met in conjunction with the Regulatory and Pharmacovigilance Departments.
• Act as primary contact for any study related medical/clinical questions and manage the preparation of responses to requests of Regulatory Authorities.
• Provide scientific leadership during engagement with external experts and stakeholders, including investigators, key opinion leaders, advisory boards, and patient advocacy groups.
• Contribute to Regulatory interactions, including preparation of clinical sections and participation to meetings as a medical expert.
• May contribute to the preparation and the execution of clinical development plans in line with Company strategies and objectives.
• Support Business Development and Licensing activities.
• Maintain close relationship/provide clinical and medical support to Clinical Operation Team to ensure smooth and effective study setup and management.
• Support Clinical Operations to identify high quality investigators and study sites for the conduct of clinical studies.
• In cooperation with the Safety Leads, ensure that any important safety issues are discussed and handled with appropriate departments.
• Work closely with Biostatistics/Data Management team to ensure Data Analysis and interpretation of data.
• Collaborate with Clinical Pharmacology to interpret and contextualise pharmacokinetic and pharmacodynamic data.
• Support preparation and finalistion of clinical study reports.
• Support preparation of study related communication plans/ publications.
• Establish and maintain excellent professional relationships between the company and Key Opinion Leaders (KOL) and the broader medico‑scientific community.
• Support discussions related to potential investigator‑initiated trials and relevance to Company portfolio and objectives.

Required Education

• Medical Doctor Degree
• Board Certification in Oncology/Haematology/Immunology will be considered a plus

Required Skills and Experience

• At least 3 yrs clinical experience (trial experience desirable)
• At least 5 yrs in the pharmaceutical/biotech industry
• At least 3 yrs in a clinical development role, with direct medical monitor responsibility for clinical trials
• Experience with Regulatory interactions and submissions
• Experience within onco‑haematology/immunology therapeutic areas and with rare diseases
• Knowledge of clinical trial methodology, including trial set‑up and conduct, protocol development, medical monitoring, review and interpretation of clinical data
• Sound knowledge of GCP
• Knowledge of Regulatory frameworks
• Familiarity with fundamental clinical pharmacology and pharmacokinetic principles as applied to Oncology drug development (e.g., dose selection, exposure–safety relationships, and interpretation of PK outputs)
• Ability to critically evaluate external assets and contribute to scientific and clinical due diligence for business development and portfolio expansion activities
• Ability to interpret and communicate complex clinical and scientific data
• Advanced communication skills with ability to interact with internal and external stakeholders
• Ability to manage multiple tasks and respond to rapidly changing priorities

Required Behaviours and Competencies

• Strong medical and scientific leadership, with the ability to influence and align diverse stakeholders
• Strategic thinking combined with a hands‑on, accountable approach to program delivery
• High level of scientific integrity, decision‑making rigour, and attention to detail
• Collaborative mindset with the ability to operate effectively in a global matrix organization

Required Languages

Fluency in spoken and written English

At Recordati we believe in people! Inspired by our purpose – unlocking the full potential of life – we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.

We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.

If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.