Medical Director/ Senior Director , Drug Safety & Pharmacovigilance

Why join us?

Parabilis Medicines (formerly FogPharma) is a biopharmaceutical company pioneering the discovery and development of Helicon therapeutics, which are peptides capable of efficient cell entry and modulation of both protein-protein and protein-DNA interactions. Through Helicon therapeutics, Parabilis is poised to revolutionize the medical possibilities for patients by precisely drugging intracellular targets long understood to be significant drivers of disease but never before drugged due to the limitations of existing drug modalities to act within the cell.

FOG-001, the company's first-in-class TCF-blocking β-catenin inhibitor, is being evaluated in a Phase 1/2 study for patients with advanced solid tumors, including colorectal cancer. Parabilis is fully leveraging the unprecedented potential Helicons present by deploying proprietary, custom-built machine learning and computational methods as part of its discovery and development process. Parabilis Medicines has raised more than $500 million to date from leading life sciences investors. Parabilis is headquartered in Cambridge, Mass.

What's the opportunity?

The Medical Director/ Senior Director of Drug Safety and Pharmacovigilance (PV) will be responsible for the management of pharmacovigilance and risk management activities in alignment with the company's development activities, industry standards, and compliance with global regulations. The Medical Director/ Senior Director of Drug Safety and PV must effectively collaborate cross-functionally to ensure efforts are aligned to meet global risk management strategies for company products. The Medical Director/ / Senior Director of Drug Safety and PV will lead and provide medical oversight for the pharmacovigilance, drug safety and risk management functions ensuring compliance and proactive and timely risk-benefit assessments for company products.

Responsibilities include:

• Oversee and direct all aspects of pharmacovigilance and risk management activities for all company products, establishing the Pharmacovigilance Department direction, standards, and processes for supporting Corporate pharmacovigilance operations.
• Lead Pharmacovigilance activities, including vendor oversight, and line management including safety operations.
• Design, direct and conduct ongoing safety surveillance of company drug products using internal and external resources (e.g. CROs/vendors) to ensure delivery of high-quality pharmacovigilance services, including oversight of patient safety in all ongoing clinical trials, including medical review of (AEs) and Serious AEs (SAEs).
• Provide medical review of adverse event reports to ensure the accuracy, integrity and completeness of information entered in the safety database.
• Establish and conduct signal management procedures including signal evaluation reports and recommendations for risk characterization.
• Lead and coordinate the program level Drug Safety Management Team (DSMT) to
• Oversee the activities of contract research/service organizations and individuals, contracted to perform drug-safety and pharmacovigilance activities
• Collaborate with cross functional departments to define and modify the benefit-risk profile of company products and provide appropriate updates to senior management.
• Provide strategic planning, implementation, and management of drug safety activities to support clinical development of company products.
• Serve as the medical safety expert for all assigned products at all stages of clinical development. As needed provide hands-on oversight of all clinical safety services including review of medical coding of AEs, con-meds, and processing of SAEs (review, query generation and resolution, and preparation of case narratives) through the entire lifecycle.
• Support responses safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans.
• Direct the development, preparation and compliance of periodic and annual safety reports (e.g., DSUR, periodic line listings, etc.), investigator communications, Risk management plans (RMP) and other reports as necessary.
• Provide medical expert safety review input for critical documents for clinical development of products (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs, ).
• Monitor industry best practices and changes in global safety regulations and guidelines. Recommends changes and upgrades to existing departmental policies, SOPs and systems to ensure global regulatory compliance.

What you'll need to be successful:

• MD. Pharm D, or equivalent.
• 5+ years leadership experience in pharmaceutical safety including a thorough understanding of case processing and other pharmacovigilance processes, with at least 3 years experience in departmental leadership and experience with a partially outsourced model, working with pharmacovigilance vendors
• Expert knowledge of FDA safety regulations, ICH Guidelines, and other applicable regulatory guidance documents; expertise in global safety regulations.
• Expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities
• Demonstrated ability to solve problems with innovative solutions along with strong organizational skills
• Possess strong and dynamic leadership skills, with excellent written, verbal and presentation skills
• Effective team player, fosters collaboration within and across functional areas.
• Sound strategic evaluation, analysis, and decision-making skills
• Able to handle pressure in a dynamic, fast paced environment.
• Ability to balance competing interests of various stakeholders and strive for achieving mutually beneficial and compliant solutions.

Core Values

Parabilis Medicines is a team of passionate pioneers who are trailblazing the future of precision medicine with the aim of making a meaningful difference in the lives of patients. The company is committed to promoting an inspiring and flourishing working environment for all employees across the business, in all departments, and driving innovation for patient benefit.

• Creative. We are creating a whole new class of medicine requiring creativity to solve challenges as they arise, which we have successfully done since the inception of the company.
• Patient-focused. We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
• Execution-oriented. As we begin clinical development and large-scale manufacturing, the team is balancing creativity and nimbleness with relentless, rigorous and flawless execution.
• Humble. We fully appreciate that science and technology and policy are in flux, and we balance deep experience with humility to ask fundamental questions and seek newly available solutions.

As an equal opportunity employer, Parabilis Medicines values diversity and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

30 Acorn Park Drive | Cambridge, MA 02140 | www.parabilismed.com