Project Manager

Category: Careers

Project Manager

Job Description

The Project Manager reports to the Associate Director of Alliances and Program Management who manages the drug development programs and the associated cross-functional teams. This position requires project management responsibilities and includes the development of tools and processes to facilitate the coordination of the team. The position is based in Austin, Texas.

Responsibilities

  • Work as part of a cross-functional project team for the development of new therapies for cancer and orphan diseases
  • Support the team in:
    • Managing project schedules and scope, tracking all internal and external tasks required to meet project milestones
    • Keeping up to date internal action items and other trackers
    • Writing and circulating agendas and minutes
    • Managing the cross functional project team’s schedule and task assignments
    • Preparing or reviewing presentations and documentation for external meeting
  • Document all requirements and participate in internal and external project meetings
  • Facilitate and contribute to the process of organizing project documentation.
  • Travel to vendor sites to attend meetings
  • Supports the Austin office in administrative tasks as requested (e.g., filing, data entry in logs, conference call invites, etc.)
  • Communicates milestones and report progress for the projects
  • Perform other related duties as required

Qualifications and Experience

  • PhD in a scientific discipline (Biochemistry, Immunology, Molecular or Cellular Biology or related field), and a minimum of 1 year related experience (may include post-doctoral experience) or an equivalent combination of education and experience.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross- functional team.
  • Ability to maintain confidential information with a high regard for integrity
  • Excellent oral and written communication skills while continually demonstrating high levels of interpersonal versatility within diverse populations
  • Strong strategic, analytical and critical thinking skills
  • Ability to build relationships and establish credibility appropriately
  • Self-reliant and results oriented. Drive balanced with patience
  • Ability to prioritize and successfully execute multiple tasks simultaneously
  • Attention to detail
  • Excellent project management skills
  • Proficiency with MS Office suite, Adobe, etc

How to Apply
Please submit your CV and cover letter in PDF format to careers@formationbiologics.com. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.

Clinical Project Manager

Job Description

The Clinical Project Manager reports to the Director of Clinical Operations/QA who bears primary responsibility for managing Formation Biologics obligations for execution of clinical trials. This position requires project management responsibilities and includes the development of tools to assist in source documentation of clinical trial oversight and quality control.

Responsibilities

• Quality reviews essential regulatory documents for study start up at research sites
• Provides oversight of eTMF system through audits twice a year. Documents findings and ensures corrective action plans are developed and implemented as applicable
• Authorizes release of Initial Investigation Drug Product to new sites and provides oversight of delivery
• Provides oversight of and assists in writing regulatory plans for clinical studies
• Ensures Standard Operating Procedures are established and maintained for all Formation Biologic delegated tasks
• Approves site payments and ensures processing after monitoring visits and query resolutions
• Participates in CRO activities as identified
• Assist in the management of the day-to-day clinical operations, including oversight of vendor deliverables (e.g., CRO)
• Coordinates and plans for the availability of clinical and non-clinical supplies necessary to meet study requirements
• Supports the Austin office in administrative tasks as requested (e.g., filing, data entry in logs, conference call invites, etc.)
• Assists in Phase 2 site selection to include feasibility data collection and on-site qualifications
• Assist in study start up activities at clinical locations
• Communicates milestones and report progress for the clinical studies
• Plans and participates in IM, KOM meetings and CRA training
• Ensure appropriate compliance with GCP, SOPs, guidelines and regulatory requirements
• Provides oversight of Close-out and Database Lock
• Reviews audit/monitoring reports for sites and works closely with Sites till resolutions
• Ensures open-communication between vendor and Formation Biologics during trial conduct.
• Maintains clinical trial protocols on clintrial.gov
• Facilitates agendas and meeting minutes for Safety Calls with sites
• Close-out and Database Lock
• Other duties as assigned

 

Qualifications and Experience

• Minimum of 5 years’ experience in Research and Clinical trials
• Held responsible roles in the conduct and management of Phase I and II clinical trials
• FDA Regulatory experience
• Minimum Bachelor’s Degree in health sciences (preferred)
• Proven ability to manage clinical trials and reach accrual goals
• Is a self- starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
• Willingness to offer full accessibility and thrive within a transparent work environment
• Ability to maintain confidential information with a high regard for integrity
• Excellent oral and written communication skills while continually demonstrating high levels of interpersonal versatility within diverse populations
• Strong strategic, analytical and critical thinking skills
• Ability to build relationships and establish credibility appropriately
• Self-reliant and results oriented. Drive balanced with patience
• Ability to prioritize and successfully execute multiple tasks simultaneously
• Excellent project management skills
• Proficiency with MS Office suite, Adobe, CTMS, etc.

How to Apply
Please submit your CV and cover letter in PDF format to careers@formationbiologics.com. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.

Apply Now

Please submit your CV and cover letter in PDF format. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.

Responsibilities

This position will help manage all major operational activities, including:

  • Manage all email, calendar and communication for senior executives, organization and collaboration with direct reports regarding all operational activities- financial, production, and HR. Maintain high level of confidentiality and discretion.
  • Oversee and manage calendars, including personal and professional appointments
  • Data room and document database creation and maintenance compiled of large quantities of information
  • Liaison between management and shareholders: handling of confidential documents and contracts, confidentiality agreements, and maintain record management, attend meetings as necessary and record minutes
  • Board meeting preparation and compilation of all material, travel, social arrangements for internal/external attendees, board dinner and meeting venue and arrangements
  • Banker and investor liaison/communication, arrange and attend client events, develop relations on behalf of executives
  • Help prepare IR presentations, and compile profile/travel/agenda information for 1x1 IR meetings for executive management
  • Support financial reporting business finance, maintain records/files for taxes, and submission of expenses
  • Support budget preparation for senior management
  • Coordinate and provide documents for accountant and CPA for month-end, quarterly, year-end, and tax filings
  • General office maintenance, follow up communication to stakeholders and associates regarding all matters
  • Gatekeeper for all incoming business, screen, prioritize, and delegate action for incoming calls, mail and email
  • Delegate tasks to other employees, communicate sensitive issues on behalf of the senior executive team
 

Qualifications and Experience

  • Minimum of 15 years of operational experience working with senior executive team and supporting corporate affairs
  • Is a self- starter and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
  • Willingness to offer full accessibility and thrive within a transparent work environment
  • Ability to maintain confidential information with a high regard for integrity
  • Excellent oral and written communication skills while continually demonstrating high levels of interpersonal versatility within diverse populations
  • Ability to build relationships and establish credibility appropriately
  • Self reliant and results oriented. Drive balanced with patience.
  • Ability to prioritize and successfully execute multiple tasks simultaneously
  • Excellent project management skills
  • High level of proficiency with MS Office suite, Adobe, CTMS, etc.
 

Apply Now

Please submit your CV and cover letter in PDF format. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.

Reporting to the Chief Scientific Officer, the Principal Scientist, is responsible for oversight of day- to-day non-clinical research activities across multiple biotherapeutic programs in immune oncology and orphan diseases. In addition, the Principal Scientist will contribute to the overall research plan for programs within the corporate portfolio.

The Principal Scientists will interface with functional groups across the organization to coordinate research activities, as well as manage external CRO and research collaboration partners. This position provides an opportunity to contribute to the building of a pipeline of promising biotherapeutics for treatment of life-threatening diseases though to launch of first-in-human trials.

Responsibilities

  • Contribute to protein engineering and design of novel biotherapeutics (antibodies, Fc- Fused traps).
  • Contribute execution and interpretation of pharmacology studies, with particular emphasis on in-vivo studies, for the evaluation and characterization of new biotherapeutics.
  • Write study protocols, craft and review final reports for internal and external use; organize data presentations and report as needed to CSO
  • Identify and vet CROs, and in conjunction with the CSO, academic groups, or organizations to conduct preclinical and bioassay studies related to mechanism of action, preclinical compound testing and lead candidate selection and development.
  • Coordinate day-to-day execution/oversight of internal/external Research studies for multiple programs, ensuring performance, timeliness and integrity of data.
  • Manage and work closely with the scientific staff to ensure alignment with corporate/partnering and IP needs.
  • Contribute to the development of research programs based on an understanding of the pathophysiology of disease and mechanism of action of biotherapeutics.
  • Independently review and apply scientific literature, his/her own scientific knowledge, and the appropriate regulatory requirements to Research efforts.
  • Identify risks, develop risk mitigation plans, and escalate risk mitigation strategies to the SVP Research as appropriate.
  • Contribute to in-licensing program due diligence and regulatory submissions.
  • Contribute to the generation of company public disclosures including scientific posters and publications, patent applications and IR documents.
  • Other related duties as assigned.

Qualifications and Experience

  • PhD in a Biological discipline, with a minimum of 7 years directly related experience, or the equivalent combination of education and experience.
  • Strong knowledge of cellular and animal models including, murine xenograft, syngeneic, GEMM, PDX, and humanized in-vivo models.
  • Experience in drug discovery and in-vivo evaluation of biotherapeutics.
  • Prior direct management experience and CRO management experience strongly preferred.
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.

Apply Now

Please submit your CV and cover letter in PDF format. Please indicate the position title in the subject line of your email. We will contact you should we wish to arrange a meeting to discuss this position further.

Scientist, Protein Engineering reports to Chief Scientific Officer and bears responsibility for structure- guided in silico protein-optimization projects using molecular-modeling and simulation software.

Responsibilities

  • Performs research and feasibility studies into proposed protein-engineering projects.
  • Designs expression constructs for antibody and protein production.
  • Participates in the development of plans, schedules and costs of assigned projects/programs.
  • Liaises with laboratory personnel and CRO staff to follow-up on the protein expression and screening for biophysical and bioactivity of the engineered molecules.
  • Prepares reports on assigned projects for internal and external use, makes presentations to team and contributes to technical journals.
  • Participates in the preparation of patents and publications.
  • Checks, organizes, analyzes and reports data produced. Prepares reports, documents and dossiers.
  • Fosters effective and collaborative working relationships with fellow employees, management and external partners.

Qualifications and Experience

  • PhD in a scientific discipline (Biochemistry, Immunology, Molecular or Cellular Biology or related field), and a minimum of 5 years’ related experience (may include post-doctoral experience) or an equivalent combination of education and experience.
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross- functional team.
  • Understanding of protein chemistry and experience in rational protein design and engineering.
  • Experience with molecular model building, simulation and visualizing packages (e.g. AMBER, CCP4, COOT)
  • Meticulous organization, record keeping and reporting.
  • Good analytical and problem solving skills, incorporating integrity in all decision making.
  • Ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
  • Effective oral and technical/scientific writing skills. Previous experience presenting scientific data to internal audiences.