At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. ã
Janssen Scientific Affairs, LLC is dedicated to providing medical information and consultative support to the Janssen pharmaceutical companies.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
- Overall strategic direction for clinical initiatives of US Medical Affairs in the mood disorder and related therapeutic area.
- Supervision of personnel supporting the design and execution of company-sponsored trials.
- Participate in the selection and supervision of investigator-initiated research.
- Develop launch and lifecycle plans for products in the mood disorder and related therapeutic area
- Guide development and execution of publications, scientific presentations and other data deliverables.
- Lead other relevant clinical and scientific initiatives.
- Adherence to project budgets and timelines, the safety and privacy of research participants, and compliance with applicable laws and regulations.
- Provide clinical and scientific leadership within the operating company, in collaboration with therapeutic area business partners elsewhere in Johnson & Johnson, and with clinicians, researchers, study investigators, regulatory authorities, and other leaders in government, industry, academia and clinical medicine.
- May participate in development of strategic priorities and in the evaluation of therapeutic compounds or platforms for in-licensing or acquisition.
- Create an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
Qualifications for the Therapeutic Area Leader, Mood Disorders include:
- An MD/DO is required with a minimum of 9 years of post-doctoral experience (clinical, academic and/or pharmaceutical).
- Board Certification or Board Eligibility in Psychiatry or significant relevant experience in Psychiatry is required.
- Seven years in the pharmaceutical industry including supervision of cross-functional project teams is required.
- Extensive clinical and scientific knowledge of mood disorders pathophysiology and management of related disciplines that are relevant to compound development and the evaluation of candidate compounds and therapeutic platforms for in-licensing or acquisition are required.
- Should have extensive experience in clinical research, which may include experience as a clinical investigator, lead investigator for clinical trials, or other related experience in clinical investigation that would contribute to a broad knowledge of pharmaceutical medicine.
- Must have expertise in the design and management of clinical trials, and have the ability to develop clinical trials that support clinical development strategies across multiple therapeutic areas.
- A demonstrated track record of research productivity is preferred.
- Pharmaceutical experience should include participation and leadership in compound lifecycle strategies, development of clinical trials aligned with these strategies, and supporting unmet clinical needs, budgetary oversight, organizational and personnel development, and demonstrated ability to collaborate effectively and exert influence in a matrix organization.
- Demonstration of effectiveness in working with industry partners in co-development, co-promotion or co-commercialization agreements is desirable.
- Knowledge of FDA regulations - including good clinical practices and regulation of pharmaceutical promotional activities, and other laws and regulations governing the investigation and promotion of pharmaceuticals, is required.
- Experience in the submission of New Drug Applications / Supplemental New Drug Applications and interactions with regulatory authorities is desirable.
- Should have experience and demonstrated competency in the supervision and professional development of other medical, technical, scientific and administrative personnel.
- Must be able to develop and administer franchise budgets, and establish and support priorities that are aligned with franchise and company goals.
- Must have excellent oral and written communication and presentation skills, and have working knowledge of computer technologies required for scientific, administrative and presentation needs.
- May require up to 20% (domestic) annual travel.
United States-New Jersey-Titusville
Janssen Scientific Affairs, LLC (6120)
Clinical Research MD
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=2001180128&lang=en
• Post ID: 53291382 southjersey