Manifold Bio
Manifold Bio is seeking an experienced drug discovery and development Project Team Leader (PTL) to lead cross-functional scientific teams to progress novel tissue-targeted therapeutic programs from early discovery to early clinical evaluation. The PTL will use their knowledge and experience of drug development, in combination with strategic guidance from company leaders, to define the integrated drug discovery and development strategies for 1-2 tissue-targeted therapeutic programs.
Responsibilities
Provides strategic and scientific leadership for cross-functional project teams focused on the development of tissue-targeted therapeutic molecules as they transition from early discovery (lead identification) into early clinical development. Develops clear work plans that map timing and resource requirements to execute critical-path activities to progress novel lead tissue-targeted therapies from lead identification through early clinical testing, including candidate nomination, nonclinical PK and safety evaluation, CMC activities, regulatory submissions, and early clinical testing. Maintains team focus on efficient execution of IND-enabling work plans. Works with project managers to track execution of critical-path activities relative to target timelines and budget. Updates strategy based on emerging scientific data, changes in the competitive landscape, and company strategic priorities; supports timely and clear project team decision-making aligned with that strategy. Facilitates identification and resolution of issues/gaps; risks and risk-mitigation strategies. Prioritizes timely, resource-efficient solutions aligned with company priorities. Ensures cross-functional project team decisions are made in a timely manner and are aligned with company strategic priorities and latest scientific data. Advocates for the program with internal and external stakeholders; supports two-way communication between senior leadership and project team members. Ensures the opinions and perspectives of internal and external partners and stakeholders are heard and understood. Fosters a team culture of rigor, grit, accountability, and continuous improvement. Position Requirements
A PhD degree in life sciences or a scientific discipline related to drug development; MD, PharmD or MS with strong scientific and drug development background also considered At least 7 years of biotech/pharmaceutical industry experience in drug development, spanning from discovery through initiation of first-in-human clinical studies Experience in discovery and development of biologic and/or oligonucleotide therapies, with a focus on neuroscience, motor, or cardiometabolic therapeutic areas preferred Excellent knowledge of drug development processes and deliverables at each stage of the pipeline Successful track record of leading projects/program teams in a cross-functional team environment from early discovery through IND-enabling activities and ideally through early clinical development Experience successfully leading projects with participation by external collaborators Experience in oversight and successful integration of CROs, CDMOs, contractors and consultants Excellent leadership skills with exceptional decision-making and analytical skills Outstanding written and oral communication skills, with proven ability to build and maintain positive, collaborative working relationships Excellent time management skills; comfortable driving toward on-time execution of deliverables in context of an uncertain drug-development environment We value different experiences and ways of thinking and believe the most talented teams are built by bringing together people of diverse cultures, genders, and backgrounds. Seniority level
Mid-Senior level Employment type
Full-time Job function
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Provides strategic and scientific leadership for cross-functional project teams focused on the development of tissue-targeted therapeutic molecules as they transition from early discovery (lead identification) into early clinical development. Develops clear work plans that map timing and resource requirements to execute critical-path activities to progress novel lead tissue-targeted therapies from lead identification through early clinical testing, including candidate nomination, nonclinical PK and safety evaluation, CMC activities, regulatory submissions, and early clinical testing. Maintains team focus on efficient execution of IND-enabling work plans. Works with project managers to track execution of critical-path activities relative to target timelines and budget. Updates strategy based on emerging scientific data, changes in the competitive landscape, and company strategic priorities; supports timely and clear project team decision-making aligned with that strategy. Facilitates identification and resolution of issues/gaps; risks and risk-mitigation strategies. Prioritizes timely, resource-efficient solutions aligned with company priorities. Ensures cross-functional project team decisions are made in a timely manner and are aligned with company strategic priorities and latest scientific data. Advocates for the program with internal and external stakeholders; supports two-way communication between senior leadership and project team members. Ensures the opinions and perspectives of internal and external partners and stakeholders are heard and understood. Fosters a team culture of rigor, grit, accountability, and continuous improvement. Position Requirements
A PhD degree in life sciences or a scientific discipline related to drug development; MD, PharmD or MS with strong scientific and drug development background also considered At least 7 years of biotech/pharmaceutical industry experience in drug development, spanning from discovery through initiation of first-in-human clinical studies Experience in discovery and development of biologic and/or oligonucleotide therapies, with a focus on neuroscience, motor, or cardiometabolic therapeutic areas preferred Excellent knowledge of drug development processes and deliverables at each stage of the pipeline Successful track record of leading projects/program teams in a cross-functional team environment from early discovery through IND-enabling activities and ideally through early clinical development Experience successfully leading projects with participation by external collaborators Experience in oversight and successful integration of CROs, CDMOs, contractors and consultants Excellent leadership skills with exceptional decision-making and analytical skills Outstanding written and oral communication skills, with proven ability to build and maintain positive, collaborative working relationships Excellent time management skills; comfortable driving toward on-time execution of deliverables in context of an uncertain drug-development environment We value different experiences and ways of thinking and believe the most talented teams are built by bringing together people of diverse cultures, genders, and backgrounds. Seniority level
Mid-Senior level Employment type
Full-time Job function
Information Technology Referrals increase your chances of interviewing at Manifold Bio by 2x
#J-18808-Ljbffr