Vice President, Clinical Research and Operations Cytokinetics
THIS JOB HAS EXPIRED Description:
We are currently seeking a key executive to join our Clinical Research and Development team to provide leadership to our clinical research physicians and our Clinical Operations and Drug Safety groups. This MD must have significant experience in the clinical development of small molecule therapeutics, ideally with formal training in one of the following areas: Neurology or Neuromuscular Diseases, Cardiovascular Diseases, Anesthesiology, Critical Care, Internal Medicine, Nephrology, or Pulmonary Diseases. The successful candidate will be a seasoned physician executive chartered to establish a critical partnership with our Chief Medical Officer/Senior Vice President of Clinical Research and Development in all aspects of designing, initiating, executing, and reporting our Phase I-III clinical studies.
Serves as a primary medical advisor to our clinical and preclinical development programs for drug candidates from our muscle biology platform, including selective skeletal muscle activators, smooth muscle inhibitors, and cardiac muscle activators.
Provides direct and indirect medical input to design, planning, initiation, execution and reporting of our clinical trials.
Approves final clinical trial protocols, investigators? brochures and final clinical study reports, and may also assist with the development of these documents.
Establishes collegial and productive relationships with prominent clinical investigators and key opinion leaders in relevant therapeutic areas in order to develop and apply the strategic intent of the Company.
Attends appropriate scientific meetings to maintain expertise in relevant therapeutic areas and represents Cytokinetics and its clinical development programs at such external events.
Represents the Company to FDA and other regulatory authorities in support of obtaining the approvals required to prosecute our clinical trials in those jurisdictions.
Conducts or supervises medical safety reviews for all our investigational drugs.
Provides technical medical expertise to the Business Development and Corporate Development functions to identify potential partners and commercial opportunities for our drug candidates; assists with due diligence for both in- and out-licensing efforts.
Acts as a key medical liaison to our partner companies.
Assumes line management responsibilities for our clinical research physicians and our Clinical Operations and potentially Drug Safety group; may also eventually take on Medical Affairs as this function is instituted and grows at the Company.
An MD degree is required, optimally with board certification in neurology or neuromuscular diseases (other specialties will be considered, as noted above). Physicians trained at major academic medical centers will be given preference.
A minimum of 15 years of relevant clinical development experience in a biotechnology or pharmaceutical company with 5+ years in a senior management capacity.
Prior experience in the line management of clinical research physicians and clinical operations personnel is required.
Strong understanding of human clinical pharmacology and pharmacodynamic/clinical endpoints.
Experience with successfully filing INDs in the United States and equivalent applications in other jurisdictions is required; successful prosecution of an NDA in the United States and an equivalent application in other jurisdictions is highly desirable.
Experience with Orphan Drug & Rare Disease regulatory support and strategy required
Demonstrated expertise in managing the design, planning, initiation, execution and reporting of Phase I-III clinical trials with an advanced understanding of the elements of statistical analysis.
Detailed familiarity with FDA regulations and ICH guidelines governing the conduct of sponsored clinical research.
Expertise in the regulations governing pharmaceutical safety reporting and surveillance.
Experience in the management of multi-national clinical trials.
Experience in the medical support of product management and marketing activities, often called Medical Affairs, a plus.
Excellent verbal and written communication and presentation skills.
Strong interpersonal skills and demonstrated leadership ability.
Experience working within multidisciplinary, cross-functional teams and demonstrated ability to influence colleagues without the benefit of direct reporting relationships.
Significant facility with commonly-used business tools such as Microsoft Word, Excel, and PowerPoint.
||South San Francisco, CA |
THIS JOB HAS EXPIRED