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Cogent Biosciences · 3 months ago

Associate Director, Investigator-Initiated Trials & Expanded Access Programs

Waltham, MA

Full-time

Onsite

Lead/Staff, Director/Executive

$160K/yr - $205K/yr

8+ years exp

Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. The Associate Director, Investigator-Initiated Trials & Expanded Access Programs will play a critical role in ensuring continued access to investigational therapies prior to commercialization by leading the strategic development and operational oversight of Expanded Access Programs, Investigator-Sponsored Trials, and Rollover Protocols.

BiotechnologyHealth CareMedicalTherapeutics

Growth Opportunities

Responsibilities

Design, implement, and manage expanded access strategies for Cogent products in compliance with global and country level regulatory requirements and internal SOPs

Lead cross-functional collaboration to enable timely decision-making, allocate resources efficiently, and maintain a seamless flow of information to internal and external partners

Oversee all aspects of the program, including timelines, budget, and resources

Collaborate with legal, pharmacovigilance, supply chain, and relevant cross functional teams to support access and distribution

Provide training and ongoing support to physicians on EAP program requirements, partnering with Medical Affairs on outreach/engagement strategy supporting access to patients

Contribute to the development of policies and strategies aligned with product lifecycle and global access objectives

Identify potential risks and develop mitigation strategies

In partnership with Medical Affairs, provide operational support for Investigator-sponsored Trials

Develop and implement processes to ensure consistent and efficient IST program execution, including tracking project timelines, managing risks, and coordinating with investigators

Develop, plan, and manage all aspects of clinical trial rollover programs, from feasibility and startup through closeout

Serve as the primary point of contact for and collaborate with internal and external stakeholders, including Medical Affairs, Regulatory Affairs, investigators, and Contract Research Organizations (CROs)

Ensure all program activities adhere to Good Clinical Practice (GCP), ICH guidelines, and all applicable national and international regulatory requirements

Develop and implement strategies to ensure efficient patient enrollment and retention within the extension program

Oversee the creation of patient-facing materials, tools, resources to improve continued trial engagement and retention

Qualification

Clinical OperationsRegulatory ExpertiseProject ManagementLeadershipBusiness AcumenPatient-Centered CareCommunication SkillsInterpersonal Skills

Required

A bachelor's degree in life science, medicine, or a pharmacy-related field is required

8+ years of relevant experience in the pharmaceutical or biotech industry, with a minimum of 3 years of direct experience managing EAP and/or IST programs

Demonstrated experience in a leadership or senior role with responsibility for program strategy and oversight

Regulatory expertise: In-depth knowledge of GCP, FDA regulations governing Expanded Access (21 CFR Part 312), and ethical considerations for clinical research

Leadership and influence: Proven ability to lead cross-functional teams and influence internal and external stakeholders without direct authority

Communication: Excellent communication and interpersonal skills, with the ability to navigate sensitive topics with patients and external partners

Business acumen: Strong financial management skills for budget oversight and contract negotiation