The Role
Who We Are
Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Our Team
https://cogent.culturehq.com
This is an exciting opportunity for a Pharmacovigilance professional who enjoys working in a dynamic fast paced environment. The Senior Manager, 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, 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 and late-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).
- Effectively collaborate with stakeholders outside of PV, including representing PV department in cross-functional clinical programs.
- 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.
- Contribute to authoring of aggregate safety reports, e.g., DSURs.
- Contribute to regulatory responses while collaborating with cross-functional areas as necessary.
- Participate in developing, implementing, and maintaining processes that are compliant with global PV regulations.
- Perform other tasks as assigned by the team.
Qualifications
- Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in Pharmacovigilance.
- Minimum 6 years’ relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety, serving in a PV scientist role.
- Experience in early and late-stage oncology trials preferred.
- Thorough understanding of safety signaling activities.
- 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).
- Comfortable in a fast-paced, high-pressure company environment and able to adapt to changing priorities.
- Must have excellent analytical and problem-solving ability.
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Ability to communicate within the organization and present ideas both orally and in writing.
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.
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The Company
What We Do
Cogent Biosciences is a 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 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.
