Senior Director Medical Affairs 9/16/2017
South San Francisco, CA
JOB DESCRIPTIONAPPLY ABOUT THE COMPANY Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for Senior Director Medical Affairs.
As part of 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 collaborate with the world for the health of everyone in it.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
The Senior Director leads the medical affairs and clinical operations team for the Endothelin Receptor Antagonist Franchise. Oversees the direction, planning, execution and interpretation of clinical research and the data collection activities for Opsumit and Tracleer.
Primary responsibilities include the following. Other duties may be assigned.
* Lead/Chair Medical team
* Co-Chair brand team with Marketing brand lead
* Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports.
* Monitors adherence to protocols and determines study completion.
* Develops systems for organizing data to analyze, identify and report data and trends.
* Interacts with various inside/outside groups to facilitate clinical trials research.
* Works closely with the Senior VP of Medical to plan and implement departmental processes and specific department and individual goals in support of Corporate objectives.
* Responsible for the development and implementation of the US medical plans.
* Brand Life Cycle Team representative for US Medical.
* Drug Safety Review Committee representative for US Phase IV program.
* Manage and oversee investigator initiated studies program.
* Partner with Regulatory Affairs on NDA annual reports, label updates and FDA communications.
* Partner with Clinical Science on clinical development initiatives.
* Function as a medical expert for Actelion 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 Clinical Leader for Phase IV studies and US only studies, manage Medical Monitors and clinical operation leads and ensuring that clinical trials are conducted according to the investigational plan, regulatory requirements of study conduct and industry standards of Good Clinical Practice as well
as Actelion SOPs. * Responsible for managing data from Phase IV clinical program.
* Responsible for the quality of data and scientific presentations, and manuscripts for publication.
* Develops brand medical strategy for advisory boards and steering committees.
* Responsible for scientific data at scientific conferences and other venues.
* Oversee the development and presentation of scientific data to internal and external audiences.
* Responsible for the content and quality of the clinical study reports for Phase IV and other regulatory documents as needed.
* Develop the US Medical strategies for medical projects.
* Manage and mentor the Directors, Associate Directors and/or managers in Medical Affairs and Clinical Operations.
* Responsible for the development of the strategic medical plan and timely execution of annual Medical Plans, both strategic and tactical.
* Partner and serve as the Medical Lead for necessary cross-functional teams within Actelion US and Global.
* Collaborate and communicate effectively with Global Medical, R&D, Life Cycle Team and other relevant teams in relation to assigned responsibilities and programs.
CANDIDATE 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.
* MD, PharmD or PhD with 12 years relevant experience of which eight years are in 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.
* Strong knowledge of PAH, pulmonary medicine and critical care
* Strong communication and interpersonal skills
* Medical science background with a strong understanding of clinical research and clinical trial design and management
* Excellent 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 needed
If 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.
Marsh & McLennan Companies and its Affiliates are equal opportunity employers
Additional BenefitsTuition Reimbursement