Director, Safety Science

Location
Brisbane, California, United States
Posted
Sep 19, 2020
Ref
512154521
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
MyoKardia is passionate about breakthrough science and transforming the treatment of rare, genetic heart diseases through a targeted medicine approach. Our clinical programs in hypertrophic cardiomyopathy (HCM), dilated cardiomyopathies, HFpEF are advancing through ongoing and planned Phase 1 and Phase 3 studies leading to growth in our Research and Development organization. The Pharmacovigilance function is led by a VP of Pharmacovigilance and has grown significantly in parallel with the company. This new role is integral to further growth of the PV organization.

The Position

The Director, Safety Science position will involve safety and risk management activities with novel agents for the treatment of a variety of rare cardiovascular diseases. These compounds are currently in Phase 1 through Phase 3/long term extension clinical trials. This highly interactive and critical role involves all aspects of pharmacovigilance with a specific emphasis on signal detection and evaluation, risk management and mitigation as well as conduct of formal benefit-risk assessments. Background in cardiology, internal medicine and ability to work across adult and pediatric indications will be strongly considered. The Director candidate, dependent on their past experience, may lead a cross-functional Global Safety Team and will be reporting directly to the VP of Pharmacovigilance.

Principal Responsibilities
  • For MyoKardia products (whether in Clinical development or Postmarketing), take medical responsibility in safety data monitoring and analysis, signal detection and evaluation and decision-making regarding the reporting and communication of newly identified safety concerns both internally and externally. Work strategically and collaboratively to assess the impact of safety concerns on usage of the product.
  • Author the product's Product Safety Plan commensurate with the stage of development/product lifecycle
  • Review clinical study protocols, protocol amendments, CDRPs, investigator's brochures, clinical study reports, statistical analysis plans and similar documents with significant safety components
  • Work collaboratively with scientists in PV Operations to assist in decisions related to management of clinical trials (need for specialized CRFs, determination of AESIs, investigator training and site education, etc.)
  • Contribute to the development of risk mitigation and management strategies throughout a product's lifecycle as well as creation of a product's Risk Management Plan (when required).
  • Provide safety contributions to key regulatory documents (INDs, IBs, Briefing documents, DSUR), clinical study reports and statistical analysis plans
  • Contribute/lead the strategy and analysis for DSURs, PADERs and PSURs
  • In conjunction with epidemiologists/data scientists develop an epidemiologic plan to contextualize the disease state and its inherent risks to both support the assessment of safety signals as well as authorship of risk management plans, when required.
  • Collaborate with research, translational research, medical affairs, and biometrics on cross-functional initiatives
  • Work collaboratively with Head of Safety Operations to enhance data quality and data integrity
  • Due diligence experienced desirable


Education/Experience
  • M.D. required, Internal Medicine and Board Certification desirable
  • Minimum 3-4 years pharmacovigilance experience working in the regulated medical products industry with a strong track record in working well with teams.
  • Experience in monitoring patient safety in a Phase 3 program is required and experience with a NDA filing is a plus.
  • Experience in signal detection and risk management required.
  • Working knowledge of statistical principles as applied to clinical development and interpretation of published scientific literature
  • Excellent communication and collaboration skills and experience working in cross-functional groups as well as demonstrated success in taking initiative in a team setting
  • Experience communicating and interacting with US/global regulators desirable
  • Ability to operate and thrive in a fast-paced environment; demonstrated flexibility
  • Comfortable with ambiguity, yet be self-motivated and timeline driven
  • Travel: 10%