Territory:
Shift: Full Time
Seniority: Director
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical force, listed on the Italian stock exchange, with over 4,300 employees.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our partners, customers, 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 The Director of Clinical Development will sit within Recordati's recently restructured R&D organisation and will be an integral part of a team whose mission is to further strengthen our global R&D capabilities.
The role will participate 'hands-on' in the preparation of the oncology portfolio clinical development plans, based on the strategy agreed with the cross-functional team, and lead several key projects. The Director of Clinical Development will establish and maintain excellent partnerships with the medical/scientific community and key opinion leaders (KOLs), as well as with patient's associations and provide medical/clinical support to the clinical operation team for the setup, conduct and finalisation of planned and ongoing trials/clinical development plans. The role will act as clinical/medical contact for HAs, IRBs, ECs for any aspect related to the implementation and conduct of clinical trials.
The role can be based at Recordati's offices in the US (NJ), UK (Hemel Hempstead), Italy (Milan), Spain (Madrid) or Germany (Ulm) and will involve international travel . We offer hybrid working with a minimum of 2 days per week in the office. Key ResponsibilitiesMaintain engagement across the global landscape with all potential investigators to identify appropriate clinical trial programs and supervise investigator-initiated trials to data portfolio.
Lead the preparation and the execution of clinical development plans at phase I, II and III including regulatory interactions, and of the study protocols, in line with company strategies and objectives.
Act as primary contact for any study related medical/clinical questions and manage the preparation of responses to clinical related FDA, EMA and other regulatory authorities' requests.
Prepare and/or supervise the preparation of all clinical documents necessary to study setup, in accordance to current regulations and laws.
Review and recommend amendments to the study protocols, investigator brochure and Informed Consent Forms to ensure study feasibility.
Ensure that the necessary regulatory, safety and data evaluation requirements are met to allow the conduct of clinical related actives in conjunction with the regulatory and pharmacovigilance departments.
Play a key role in lifecycle management and business development activities
Maintain close relationship/provide clinical and medical support to clinical operations team to ensure smooth and effective study setup and management.
Participate in internal and external clinical meetings, including committees to assess/approve support to investigator-initiated trials, investigators meetings and Advisory Boards, related to assigned clinical studies.
Support to 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 statistics/DM team to ensure data analysis and interpretation of data.
Prepare and finalise clinical study reports.
Prepare the study related communication plans and publications
Required Education Qualified physician – b oard Certification, eligibility, or fellowship training in oncology is required. Required Skills and Experience More than 5 years' pharma experience in a clinical development regional/multi-country role at a similar level with an oncology focus Rare disease experience is preferred Track record of successfully working within and coordinating cross functional team Experience in protocol writing and preparation of submission to regulatory authorities. Experience in trial data analysis, interpretation, reporting and presentation (oral presentation, posters, publications). Experience in communication with FDA/EMA Previous participation or coordination of advisory boards. Training in statistics or clinical trial methodology. Required Behaviours and CompetenciesHighly motivated, dynamic physician with aspiration to evolve and develop in the clinical development space.
Strong interpersonal, presentation, and excellent written and verbal communication skills.
Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.
Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
Develops technical and/or business solutions to complex problems.
Demonstrable ability in decision-making, influencing, leadership, and affecting change by using a collaborative approach.
Results orientated work ethic and a positive, can-do attitude.
Strong organizational and time management skills.
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Comfortable challenging the status quo and bringing forward innovative solutions
Highly motivated, self-driven
Willing and able to be "hands on" and willing to "roll-up sleeves" and delve into details as needed
Creates formal networks involving coordination among groups.
Required Languages Fluency in written and spoken English. Additional European languages would be advantageous
Travel required in % International travel will be required, up to 20%
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.
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