Associate Director/Director Drug Safety & Pharmacovigilance Operations

Why join us?

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, FogPharma 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. FogPharma 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. FogPharma has raised more than $500 million to date from leading life sciences investors. FogPharma is headquartered in Cambridge, Mass.

What’s the opportunity?

Position Summary

The Associate Director/Director of Drug Safety & Pharmacovigilance (DSPV) Operations provides leadership and oversight to the DSPV department, including overseeing pharmacovigilance vendors, serving as an internal subject matter expert, and furthering the development and implementation of the pharmacovigilance system in support of Fog Pharma products.

Responsibilities

• Drive strategic planning, implementation, and management of DSPV Operations and Compliance activities
• Provide oversight and management of outsourced PV operational activities
• Develop and maintain PV related documentation (e.g., Safety Management Plans, reporting forms, etc)
• Represent DSPV on project teams and committees, as needed
• Oversee the set-up of new clinical trials/products within DSPV (e.g., development of Safety Management Plans, reporting forms, review of eCRFs)
• Review clinical documents and study plans as requested (e.g., protocol, informed consent, etc)
• Contribute to the preparation of aggregate safety reports
• Support signal management activities
• Contribute to development and maintenance of Pharmacovigilance or Safety Data Exchange Agreements (PVAs/SDEAs) with partners or other third parties
• Support inspection readiness activities and participate in regulatory inspections
• Ensure overall compliance of the PV system in accordance with global regulatory requirements
• Review and monitor vendor quality and compliance of outsourced PV operational activities
• Develop, review and deliver PV related training
• Collaborate with key stakeholders at all levels of the organization and across multiple functions
• Provides expert guidance and leadership based on in-depth knowledge of safety requirements, per ICH, local and global regulations and guidelines, and Good Pharmacovigilance Practice (GVP)
• Oversee the resourcing, budget, and management of the PV vendor
• Maintenance of the DSPV mailbox and SharePoint

What you’ll need to be successful:

• Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (RN, PharmD, NP, PhD, MPH, etc.)
• Eight + (8+) years working in DSPV Operations within the pharmaceutical or biotechnology industry with in-depth knowledge of Good Clinical Practice (GCP); GVP; ICH guidelines; FDA, EMA, and other international regulations and guidelines; clinical trial conduct, and process and quality management.
• Strong leadership and management skills, with a track record of building and developing high-performing teams.
• Experience overseeing and managing PV vendors
• Previous experience with safety database programs (e.g., Argus, ARISg)
• Strong interpersonal and communication skills (both written and oral)
• Self-motivated and adaptable in a dynamic, nimble, start-up environment
• Detail-oriented, with good organizational, and time management proficiencies. Must be able to work on multiple projects simultaneously
• Demonstrated and creative problem solving skills (including taking ownership to ensure timely resolution) and the ability to successfully execute in an environment under time and resource pressures
• Ability to establish priorities, excellent sense of urgency and a strong desire to collaborate (self-aware, effective relationship management and interpersonal skills)
• Strong computer skills and experience using Microsoft Office applications
• Ability to work on-site or remotely and attend in-person meetings
• Ability to work cross culturally and with a variety of time zones

Core Values

FogPharma 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.

Growth Mindset

We’re inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable

In(ter)dependent

We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.

 Patient Focused

We are deeply focused on patient outcomes, and all energy in the company is focused on translating science to patient impact

All In

We’re All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

As an equal opportunity employer, Fog 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.fogpharma.com