• Ferring Pharmaceuticals
  • $131,430.00 -199,650.00/year*
  • Parsippany , NJ
  • Healthcare - Physician
  • Full-Time
  • 125 Janelle Blvd

Job Title:Medical Director, Gastroenterology/HepatologyJob Description:

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology), orthopedics and Oncology. Ferring's US operations employ approximately 900 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary: Medical and scientific expertise within the therapeutic area Gastroenterology-Hepatology and an understanding of immunology and metabolism in disease pathophysiology, with the objective to further and build a portfolio at different R&D stages; strategic input in internal programs and external innovation efforts. Contributing to high quality R&D development plans and study designs, in line with the TA and R&D strategy and in cross-functional teams. Scientifc-Medical evaluation of in-licensing opportunities. Contribution to writing regulatory documents and interaction with Health Authorities.

Responsibilities:

* Scientific-medical contribution to positioning of investigational compounds based on pathway-based indication(s) selection and unmet medical needs;
* Scientific and medical contribution to nonclinical, clinical and regulatory documentation (Investigator's Brochures, IND submissions and consultatory documents, trial protocols & reports). Responsible for medical-scientific content and interpretation of clinical documents to be submitted as part of registration dossiers in collaboration with Regulatory and other R&D functions.
* Contribute to development plans at different stages of R&D with scientific medical input on rationale, indication selection, safety plans, biomarkers and endpoints; provide support for a mechanism of action and disease biology driven R&D strategy. Ensure proper design of individual clinical studies and provide medical leadership to the clinical operation group to conduct and implementation. Participate in data analysis and presentation of data
* Provide scientific and medical TA expertise in a cross-functional environment, including clinical and non-clinical functions, Discovery, Regulatory Affairs, Innovation and Business Development, Project Management, Medical Affairs and commercial. Support R&D TA strategy efforts in the therapeutic teams. Active participation, scientific-medical evaluation and due diligence reports of in-licensing opportunities in the TA
* Contribute to safety evaluation, medical monitoring, and TA expertise oversight in clinical trials/ programs, DSMB Management and risk management plan for projects in the TA, in close collaboration with Global Pharmacovigilance.
* Participate as needed in life cycle management in collaboration with Medical Affairs, e.g., indication extension; data analyses, data mining, etc. for clinical documents, abstracts and publications. Responsible for the publication and presentation of TA data as required. Provide input to the TA publication strategy.
* Adherence to Good Clinical Practice, SOPs and regulatory requirements.
* Ensuring the development and maintenance of relationships and co-operation with regulatory authorities and other appropriate external bodies. Maintain scientific peer relationships with external experts and institutions of excellence.
* Up to date knowledge within the TA and transmit this knowledge to the rest of the department and organisation.

Requirements:

* Medical Doctor, preferably with a PhD or advanced science degree and strong analytical skills
* Understanding of immune and metabolic pathways in human disease, ideally with clinical experience in gastroenterology and hepatology
* 5-10 years' experience in the pharmaceutical industry or notable academic career
* Basic understanding of relevant GCP, guidelines and regulatory requirements
* Innovative, flexible, self-starter with ability to multi-task, prioritize and work independently. Excellent planning and organizational skills
* Team player, relationship builder with ability to collaborate across departments and globally; providing scientific-medical leadership to project teams
* Experience working in a multi-cultural environment and in a matrix structure

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email ...@ferring.com

Location:Parsippany
Associated topics: administrative, administrative assistant, administrative coordinator, administrative staff, asso, beverage, chief operations officer, facilities, front desk, operations director

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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