Johnson & Johnson is recruiting for a Clinical Leader, Pulmonary Hypertension located in Cherry Hill, NJ or Allschwil, Switzerland.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.
The R&D organization numbers over 11,000 employees based across 10 research hubs around the world. Janssen operates across six therapeutic areas - Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, Cardiovascular and Metabolism and Pulmonary Hypertension.
Pulmonary Hypertension is the most recent therapeutic area for the business and formed through the acquisition of Actelion in June 2017. This $30BN acquisition represented one of the largest and most high-profile acquisitions of the last decade and by integrating Actelion’s significant operations into the JnJ group, Janssen has assumed market leadership in the field of Pulmonary Arterial Hypertension.
The company has two major products already on the market – Opsumit® (macitentan) and Uptravi® (selexipag) – each with a long patent life ahead of it. Both products have demonstrated long-term outcome benefits in large randomized controlled trials where they were used in combination with other PAH-specific therapies. Both Macitentan and Selexipag are being investigated in additional PAH indications such as Chronic Thromboembolic Pulmonary Hypertension and in pediatric conditions.
Pulmonary Hypertension is a collection of rare diseases that are progressive and, most importantly, an area where significant unmet medical need remains with 40% of PH patients dying within seven years of diagnosis. Janssen is dedicated to building on Actelion’s 20-year legacy of ground-breaking innovation in PAH and is committed to improving the life of these patients and has an overall vision to cure Pulmonary Hypertension. In addition to this, the company will also focus on adjacent disorders such as Idiopathic Pulmonary Fibrosis, sarcoidosis and other serious and rare cardio-pulmonary diseases.
Johnson and Johnson has an outstanding reputation as an organization and employer and has spent the last thirty years on the Fortune Magazine “Most Admired Companies”. It is one of only two AAA rated companies in the world.
As Clinical Development Leader you will be responsible for providing input, oversight and guidance on Clinical Development Programs and their execution from conception of strategy to design, implementation, execution, and submission/approval under the guidance of the Sr. Clinical Leader. You will also provide medical support internally for all Clinical Development Science (CDS) - responsible project activities through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to the disease area.
You will be working on one of Janssen’s flagship Pulmonary Hypertension assets, Macitentan. This is an exciting period for the franchise as the company is investing heavily into the area. This includes the recent commencement of one study and two more planned for early 2020. These very large studies will be in pulmonary hypertension related indications – PH caused by pulmonary embolism and PH associated with left heart failure.
The position reports into the Senior Clinical Leader who joined the organisation last year. This is a highly qualified MD with a long academic record in the field of Pulmonary Hypertension. The Snr Clinical Leader heads a small but highly qualified group consisting of four MDs and a wider clinical science group (non-MDs). Although the core of the R&D group is in Switzerland, there is an even split in the clinical science unit between Switzerland and the US.
As Clinical Development Leader you will be responsible for all aspects of the Clinical Development Program and the execution from conception of strategy to design, implementation, execution, and submission/approval. This is a highly visible role internally and you will be regarded as a key medical resource providing support across all Clinical Development Science (CDS).
This is a key strategic function within the group and you will be a critical figure as the organization expands into adjacent cardio-pulmonary disorders. The position offers great career development potential both within this latest therapeutic area or across the broader Janssen structure.
Externally, you will liaise with opinion leaders and regulatory bodies and represent the world’s largest and most reputable pharmaceutical company. As such, you must be able to communicate complex scientific topics with relative ease. Responsibilities include:
- Provide direction and leadership for the assigned Clinical Development Programs.
- Maintain knowledge of therapeutic area(s) and indications, as well as maintaining knowledge of current relevant regulations and guidelines to ensure safe and ethical conduct of trials.
- Attend relevant medical conferences and maintain knowledge of key publications.
- Support the assessment of new in-licensing opportunities and business development activities / due diligence evaluations.
- Provide medical leadership internally:
- Develop and implement a clinical development strategy to ensure high quality clinical trials and respect of timelines.
- Undertake product and therapeutic area reviews and provide input to the study-related, strategic and regulatory documents.
- Accountable for the delivery of the medical aspects of the Clinical Project Development Plan (CDP) related to the indication and executing its implementation.
- Responsible for the development and approval of the core medical/scientific information required in all clinical documents (e.g., protocols, statistical analysis plans, core informed consent forms, clinical study reports, investigators’ brochure, clinical components of regulatory submissions, safety related documents), and assure production of high-quality documents.
- Provide medical input on behalf of CDS to the monitoring and analysis of the safety profile of the product together with Global Drug Safety.
- Responsible for ensuring projects are adequately supported medically and prioritized to ensure timely and on-target delivery on set objectives and deliverables in line with clinical development goals.
- Interface medically with affiliates as needed to provide product and therapeutic area training and to raise global project awareness for the product, both to stimulate recruitment and prepare the ground for potential future commercialization.
- The following responsibilities may be required as well based on the specific project / trial:
- Be the key physician contact for sites and investigators during study start-up and study execution, act as a liaison between the company and clinical investigators, CRO’s, and CRA’s.
- Present trial- and compound- related information at Investigator Meetings and internal training sessions.
- Lead medical review, interpretation, and reporting of the results of the research, including submission to health authorities.
- Oversee preparation of medical narratives on research subjects as needed
- Provide program input:
- Manage and support (with medical and scientific input) strategic decisions of the Compound Development Team (CDT) for assigned Project.
- Accountable for delivering/maintaining a Clinical Development Plan (CDP), that addresses regulatory and clinical requirements for a successful program development strategy. Responsible for discussing and addressing key scientific and medical issues.
- Overall accountable for the scientific, ethical and regulatory conduct of all study related deliverables within his/her assigned program.
- Accountable for content of medical input on behalf of Clinical Science to the monitoring and analysis of the safety profile of the product, together with the Project Physician / Study Responsible Physician and Drug Safety Physician. This task may be delegated to the Scientific Leader as appropriate.
- Interface with Research, Medical Affairs and Global Commercial Strategy.
- Accountable for all clinical trial deliverables of assigned programs, along with the ongoing assessment / identification of program risk and implementation of mitigation strategies:
- Oversee development of scientifically sound clinical study documents (protocol, SAP, CSR) that are aligned with clinical development strategy
- Contribute clinical/medical expertise and content of clinical sections of regulatory documents such as briefing books, NDAs/MAAs etc
- Accountable for tracking/analysis of any potential safety signal across clinical trials under his/her responsibility
- Supervises and supports Project/Trial-Responsible Physicians, as needed
- Interact with clinical investigators and Key Opinion Leaders as appropriate.
- Work closely with Data Management and with Biostatistics and Data Management. Leads the review, interpretation and communication of study results
- Leads the development and compilation of clinical sections of NDA/MAAs and supports responses to Health Agency questions and HA presentations post-filing.
- May review/co-author medical publications, emerging from clinical trial results.
- Assess and plan for external clinical research opportunities in collaboration with the Senior Clinical Leader and Business Development.
- Provide external medical leadership (delegate to Molecule Responsible Physician as appropriate):
- Accountable for the development and maintenance of contacts with Key Opinion Leaders and Investigators.
- Accountable for all clinical Advisory Boards, Steering Committee Meetings and Data Monitoring Committees.
- Represent company at key regulatory interfaces, Investigator Meetings, internal team and management meetings as well as partner meetings where applicable.
- Plan and execute publication and clinical communication strategy in coordination with Medical Communications.
- Upon request of management, support the assessment of in-licensing opportunities and due diligence activities and presentation of recommendations to senior management
- Maintain knowledge of therapeutic area and pharmaceutical development regulations:
- Attend relevant medical conferences and maintain knowledge of relevant literature and publications.
- Ensure clinical trial activities comply with the highest quality/ethical standards
- Deputizes for the Sr. Clinical Leader as a representative at the CDT.
- Deputizing the Sr. Clin. Leader as representative of Clinical Science to company Strategic Boards.
- Perform objective setting and performance review at mid and end of the year for all Clinical Science employees reporting to him/her.
- Discuss and negotiate with the Sr. Clinical Leader resources to be allocated to the program.
Must possess intimate knowledge of clinical development and clinical trial design including a working understanding of standard statistical methodologies is required.
First-hand experience with handling inquiries/requests from regulatory agencies highly desirable.
Sound knowledge of regulatory requirements, International Council for Harmonisation - Good Clinical Practice (ICH-GCP) guidelines is required.
Good organizational skills, and able to effectively work as part of a team in a matrix environment and independently is required.
Motivated and energetic individual with high personal and ethical standards is required.
Flexible mindset, agile, and able to deliver on timelines and to strict deadlines is required.
Demonstrated ability to think strategically is required.
Excellent communication skills - strong verbal, written, and presentation skills are essential is required.
Detail-oriented with a hands-on approach is required.
Strong scientific oral and written communication skills is required.
Demonstrated analytical and problem-solving skills with strong ability to persuade and influence at the project team level and management level is required.
Good communication skills and ability to lead by influence is required.
Willingness and ability to travel (not expected to be more than 20%) on a national and international basis is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability
United States-New Jersey-Cherry Hill-
Janssen Research & Development, LLC (6084)