Director, Pharmacovigilance Scientist

Who We Are

Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.

Our Team

https://cogent.culturehq.com

This is an exciting opportunity for a Pharmacovigilance professional who enjoys working in a dynamic fast paced environment. This is a high visibility role with significant impact on the development of our pipeline. The Director, Pharmacovigilance Scientist plays a pivotal role within PV to develop and maintain safety assessments in accordance with the regulations and guidelines. The ideal candidate will provide scientific/clinical expertise, strategic input, support for deliverables and activities associated with signal management, safety, and benefit-risk evaluations for assigned development compound(s). This role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Operations, Clinical Development, and Regulatory Affairs.

Responsibilities

• Supports early-stage development products
• Oversight of day-to-day safety monitoring activities of clinical trials for the assigned product(s)
• Perform signal management activities including – signal detection, analysis, and tracking for the assigned product(s)
• Provide PV subject matter expertise at cross-functional meetings throughout the company
• Effectively collaborate with stakeholders outside of PV, including representing PV department in cross-functional clinical programs
• Plan and participate in Safety Committees (e.g., Safety Management Team and Independent Data Monitoring Committees meetings); may include coordinating data, slide creation, data presentation, agenda drafting, and minutes
• Provides PV input for development of protocols, Investigator’s Brochure, Informed Consent Forms, Clinical Study Reports, and other relevant study documents
• Lead in writing of aggregate safety reports, e.g., DSURs

Qualifications

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
• Minimum 8+ years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety, serving in a PV scientist role.
• Experience in signal detection activities with demonstrated experience in analysis, and interpretation of medical and scientific data.
• Knowledge of MedDRA terminology and its application.
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex information and safety data.
• Experience in the preparation and authoring aggregate safety reports.
• Knowledge of Pharmacovigilance regulations and guidelines including Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
• Ability to work effectively in a collaborative small team environment.




• Preferred Qualifications
• Healthcare professional degree preferred (PharmD, RPh, RN, NP, PA)
• Experience in early-stage
• Oncology experience
• Ability to work effectively in a collaborative small team environment
• Must have excellent analytical and problem-solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Excellent communication skills and ability to influence multiple functions

Our Locations

Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.

Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.

Our Offer To You

To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.

We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.