Director/Senior Director, Project Management
5AM Ventures, Berkeley, California, United States, 94709
Overview
We are a clinical-stage biopharmaceutical company specializing in the development of novel long-acting therapeutics for obesity and related metabolic disorders. Our team invents, develops, and uses novel drug delivery technologies that enable controlled, predictable, and sustained release of drugs over weeks or months. Our approach has the potential to enhance pharmacokinetics, efficacy, and safety while significantly reducing dosing frequency.
Position To support the Company’s next phase of growth, we are establishing a full-time project management position. The incumbent will work closely with executive management and subject matter experts (SMEs) across the Research, Product Development, Nonclinical, Clinical, and G&A functions to ensure execution and advancement of the Company’s product portfolio against integrated development plans, timelines, and budgets. The Director/Senior Director will partner with project leaders to manage individual programs at various stages of research, preclinical, and clinical development, and will also provide support for overall pipeline/portfolio management. In addition, the incumbent will work closely with the G&A function to establish and/or optimize processes and systems, including, among others, budgeting/change control, quality/SOPs, vendor qualification/oversight, contracting, and risk management.
Responsibilities
Oversee project management activities across the company’s product portfolio
Facilitate the development and management of integrated program plans within the broader portfolio management strategy, including advancement of programs from preclinical lead through to development candidate, IND-enabling activities, and into clinical development
Design and implement the company’s formal project management frameworks, including standardized templates for reporting, risk logs, and decision-tracking
Facilitate and document project team meetings, cross-functional communication, and decision making, ensuring alignment with internal functional groups and leadership
Identify and manage project objectives, work plans, timelines, and budgets, providing formal and informal status updates to stakeholders as needed
Interface with project teams, team leaders, and executive management on project requirements, status review, and key development decisions
Establish and maintain functionally integrated project plans, including timelines; identify critical path activities, resource constraints, and potential acceleration opportunities
Manage and track risk mitigation strategies
Seek opportunities for business process improvements
Manage key external vendor activities and associated budget when required
In collaboration with the G&A function, support the budgeting, change control, and resourcing processes, including optimization of processes and systems as needed
Qualifications
Bachelor’s degree or higher in a relevant field, preferably related to life sciences. Master's/PhD degree preferred.
PMP certification a plus
10+ years of multi-disciplinary experience in the pharmaceutical/biotechnology industry.
Experience with both early and late phase pharmaceutical project management, including IND/CTA, NDA/MAA submissions.
Successful track record of managing complex cross-functional programs, including in-depth knowledge of the drug development process and inter-dependencies of key functions to include research, pharmaceutical development, non-clinical, clinical PK, metabolism, clinical research, and manufacturing. Experience with drug development outside the US is desirable
Proven ability to work independently on multiple projects and priorities in a small, fast-paced biotech environment.
Experience developing and managing program budgets and timelines, including proficiency in relevant tools and software (e.g., SmartSheets).
Strong interpersonal skills with demonstrated ability to effectively work with cross-functional groups comprised of employees and contract workers/consultants.
Demonstrated ability to lead and manage high-performing teams.
Excellent written and verbal communication skills.
This is a hybrid position (at least 2 days in the office/week). Flexibility may be available based on program needs.
Occasional travel may be required
$200,000 - $260,000 a year
Final compensation will be based on a candidate’s qualifications, experience, and geographic location. Employees are also eligible for performance bonuses, equity participation and comprehensive health benefits.
We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don’t hesitate to apply!
ProLynx Inc. is an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected.
Please note that we do not accept unsolicited resumes from recruitment agencies and external recruiters. No fees will be paid for such submissions.
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Position To support the Company’s next phase of growth, we are establishing a full-time project management position. The incumbent will work closely with executive management and subject matter experts (SMEs) across the Research, Product Development, Nonclinical, Clinical, and G&A functions to ensure execution and advancement of the Company’s product portfolio against integrated development plans, timelines, and budgets. The Director/Senior Director will partner with project leaders to manage individual programs at various stages of research, preclinical, and clinical development, and will also provide support for overall pipeline/portfolio management. In addition, the incumbent will work closely with the G&A function to establish and/or optimize processes and systems, including, among others, budgeting/change control, quality/SOPs, vendor qualification/oversight, contracting, and risk management.
Responsibilities
Oversee project management activities across the company’s product portfolio
Facilitate the development and management of integrated program plans within the broader portfolio management strategy, including advancement of programs from preclinical lead through to development candidate, IND-enabling activities, and into clinical development
Design and implement the company’s formal project management frameworks, including standardized templates for reporting, risk logs, and decision-tracking
Facilitate and document project team meetings, cross-functional communication, and decision making, ensuring alignment with internal functional groups and leadership
Identify and manage project objectives, work plans, timelines, and budgets, providing formal and informal status updates to stakeholders as needed
Interface with project teams, team leaders, and executive management on project requirements, status review, and key development decisions
Establish and maintain functionally integrated project plans, including timelines; identify critical path activities, resource constraints, and potential acceleration opportunities
Manage and track risk mitigation strategies
Seek opportunities for business process improvements
Manage key external vendor activities and associated budget when required
In collaboration with the G&A function, support the budgeting, change control, and resourcing processes, including optimization of processes and systems as needed
Qualifications
Bachelor’s degree or higher in a relevant field, preferably related to life sciences. Master's/PhD degree preferred.
PMP certification a plus
10+ years of multi-disciplinary experience in the pharmaceutical/biotechnology industry.
Experience with both early and late phase pharmaceutical project management, including IND/CTA, NDA/MAA submissions.
Successful track record of managing complex cross-functional programs, including in-depth knowledge of the drug development process and inter-dependencies of key functions to include research, pharmaceutical development, non-clinical, clinical PK, metabolism, clinical research, and manufacturing. Experience with drug development outside the US is desirable
Proven ability to work independently on multiple projects and priorities in a small, fast-paced biotech environment.
Experience developing and managing program budgets and timelines, including proficiency in relevant tools and software (e.g., SmartSheets).
Strong interpersonal skills with demonstrated ability to effectively work with cross-functional groups comprised of employees and contract workers/consultants.
Demonstrated ability to lead and manage high-performing teams.
Excellent written and verbal communication skills.
This is a hybrid position (at least 2 days in the office/week). Flexibility may be available based on program needs.
Occasional travel may be required
$200,000 - $260,000 a year
Final compensation will be based on a candidate’s qualifications, experience, and geographic location. Employees are also eligible for performance bonuses, equity participation and comprehensive health benefits.
We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don’t hesitate to apply!
ProLynx Inc. is an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected.
Please note that we do not accept unsolicited resumes from recruitment agencies and external recruiters. No fees will be paid for such submissions.
#J-18808-Ljbffr