Program Lead

4 days ago

Cary, United States Chiesi Full time

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with over 85 years‘ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people‘s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work.
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

What we offer

Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that ‘Every one of us is different. Every one of us is Chiesi.‘

Purpose

The CPL is a permanent member of a cross-functional R&D global Core Team (CT) who plays a key role in defining the target disease profile (TDP), target product profile (TPP), and the development and life cycle strategies of a given project. The CPL leads the Clinical Development (CD) Team (which consists of functional leaders from within GCD e.g.: Clin Pharm, Clin Ops, Biostats, etc.) in the design and execution of the clinical development plan (CDP) from Phase I to Phase IV. The CPL is the senior clinical signatory on all clinical documents related to a project including Phase I-IV study protocols, Investigator‘s Brochures, Risk Assessment & Mitigation Plan, publications, and is responsible for all clinical aspects related to the Clinical Trial Dossier (clinical modules, briefing books, scientific advice, meetings with regulatory agencies, etc.) and is the main clinical contact with external though leaders, professional societies and patient advocacy groups. The CPL serves as the principal internal clinical resource for R&D concerning the disease area and project, working with other members of the Core Team to raise disease awareness and product knowledge levels within Chiesi.

At Chiesi, CPLs may also serve as clinical research physicians on select phase I-IV studies, where needed.

Main Responsibilities

* Develops the TPP and the Clinical Development strategy as a member of the Core Team and with input from the CDP team
* Coordinates alignment and agreement on CDP matters with the CDP Team, Core Team and GCD-LT
* Ensures that the design of each clinical study is consistent with the CDP
* Ensures that the CDP is in line with the approval path agreed with Regulatory Agencies and with the agreed business plan & objectives
* Provides clinical approval (protocols, CSRs, lay summaries, clinical trial disclosure &/or deferral strategy, data sharing requests)
* As part of the Submission Team, prepare/review Briefing Books, eCTD modules, represent clinical aspects during interaction with Regulatory Authorities
* Regularly updates the CDP team all aspects discussed at Core Team or internal bodies
* Secures necessary internal approvals & external endorsement (e.g. disease area experts, consultants) to the CDP elements
* Ensuring accurate & timely documentation of all actions and decisions related to the CDP.

Experience Required
  • Required experience/background: A significant experience in designing and executing a comprehensive clinical research & development plan. At least 5 years in an R&D role in the pharmaceutical/biotech industry, or 7-10 yrs in academia with clinical investigator track record. Experience within respiratory therapeutic area is very highly preferred.
  • Technical skills: Fluent written and verbal communication skills in English. Ability to interact with academic and regulatory experts with confidence, integrity and persuasion. Strong business acumen, able to see the big picture and to weigh pros and cons and drive towards an informed decision. Strong ability in analysing and interpreting complex data sets.
  • Managerial skills: Leading a cross-functional team, working in a matrix environment, problem-solving, motivating team members and providing a safe environment for the expression and exchange of innovative thoughts and ideas. Courage to take initiative and to learn from failures and setbacks. Excellent communication with peers, stake holders, Sr. managers, and teammates
  • Pharmaceutical industry / Clinical Investigator experience: 7-10yrs for CPL
  • Proficiency in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance
  • Demonstrated proficiency in Written, Verbal and Face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies
Education
  • Medical Doctor Degree required
  • certification in Respiratory Diseases/Pulmonology will represent a plus

Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, veteran status, gender identity or expression or any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one‘s employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.

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