Job Details

Loc: South San Francisco, CA

Job Responsibilities :

• Primary responsibilities include the following. Other duties may be assigned.
• Function as a medical expert for company products and provide expertise as needed within and outside the organization .
• Build strong relationships with key opinion leaders (KOLs) in the therapeutic area of interest and be committed to continuous scientific exchange with KOLs as appropriate in the field and during medical congresses .
• Act as the Medical Monitor for product Phase IV studies ensuring that clinical trials are conducted according to the investigation plan, regulatory requirements of study conduct and industry standards of Good Clinical .
• Practice as well as company SOPsPrepare study protocols, amendments, specific sections of study manuals and other documents as neededCoordinate and implement ongoing data for internal analysis and review .
• Coordinate the preparation and/or review of data listings, summary tables, study results, scientific presentations, and manuscripts for publication .
• Develop product medical content for advisory boards and steering committeesPresent scientific data at scientific conferences and other venues as needed .
• Prepare scientific data for Medical Affairs team and/or Sr VP of Medical as needed for internal and external presentationsDevelop and complete clinical study reports for Phase IV and other regulatory documents as needed .
• Provide medical and scientific feasibility for product medical projectsDevelopment of medical and scientific materials when needed for purposes of medical education internally for relevant teams as well as for HCPs/KOLs externally .
• Work with Medical Director in development and timely execution of annual product Medical Plans, both strategic and tacticalPartner and serve as the Medical Lead for necessary cross-functional teams within Medical, such as Publications, Drug Safety, Medical Information, PRC, MRC; within brand team, such as ARC to support these teams from a medical perspective and maintain.
• Company scientific leadershipCollaborate and communicate effectively with Global Medical, Life Cycle Team and other relevant teams in relation to assigned responsibilities and programsServe as the product medical conduit with Specialty Pharmacy in order to maintain medical relationship, provide product training and to provide medical guidanceCandidate .

Qualifications & Requirements :

• This job requires a combination of analytical, organizational and interpersonal skills. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the knowledge, skill, and/or ability required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• RequiredMD, PhD or PharmD with eight years relevant experience of which 5 years are pharmaceutical / biotech industry in medical affairs or clinical development, with strong medical focus and experience in regards to medical plans, publications, medical information, education grants, investigator initiated studies, and Phase IIIb/IV programs, or equivalent academic or clinical experience.
• PreferredMD, PhD or PharmD with eight years relevant experience of which 5 years are pharmaceutical / biotech industry in medical affairs or clinical development, with strong medical focus and experience in regards to medical plans, publications, medical information, education grants, investigator initiated studies, and Phase IIIb/IV programs, or equivalent academic or clinical experience.
• MD (cardiologist or pulmonologist)Strong knowledge of PAH, pulmonary medicine and critical careStrong communication and interpersonal skillsMedical science background with a strong understanding of clinical research and clinical trial design and managementExcellent interpersonal skills .
• Ability to form strong relationships based on credibility and trust, be able to work within teams and handle a fast-paced work environment .
• Ability to travel within and outside of the US as neededIf you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your application.Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.