Position: Director, Program Management
Reports to: Executive Director, Program Management
ContraFect is a clinical stage biotechnology company focused on discovering and developing therapeutic proteins and antibodies for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. An estimated 700,000 deaths worldwide each year are attributed to antimicrobial-resistant infections. Our lysin and monoclonal antibody platforms target conserved regions of bacteria or viruses (regions that are not prone to mutation). ContraFect's initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (methicillin resistant Staph aureus) and influenza.
An opportunity is available to grow with us in an environment that is both challenging and energetic. ContraFect is seeking self-motivated and collaborative individuals to join our team and to contribute their talent and expertise to the team. We are looking for positive individuals who will add the strength of their personality to our committed and dedicated employee base and contribute to the development of novel therapeutic agents which have the potential to change the therapeutic landscape for treating serious infections.
It is an exciting time in our Company’s history. CF-301, our lead compound, is the first and only bacteriophage-derived lysin to enter clinical development in the US, and has recently completed a global Phase 2 study. CF-301, which targets Staphylococcus aureus, including MRSA, is a member of a new class of protein-based therapeutics for the treatment of serious bacterial infections. We are using ContraFect’s technical expertise to develop biotherapeutic products for infectious diseases that have high unmet medical needs, particularly products used in hospital-based markets.
The Director, Program Management is a key position responsible for the operational execution for ContraFect’s Early Discovery and CMC programs. The incumbent must have prior drug development experience (preferably with biologics) and will ensure seamless integration of operational activities and scientific imperatives to ensure execution, scientific excellence and delivery of programs within time, cost and quality parameters. This position has primary responsibility for the operations and completion of projects to meet ContraFect’s company objectives and in accordance with highest standards of quality, data integrity and compliance.
The successful candidate will ensure alignment across all internal and external contracted parties responsible for study conduct (e.g. within ContraFect’s Subteams and across Contract Research Organizations (CROs) and vendors) to ensure operational efficiency, adherence with the fully executed budget, and successful attainment of program milestones that are aligned with government grant commitments (e.g. DOD, CARB-X, etc….).
This position will report to the Executive Director Global Program Management and contribute to program strategy, risk assessment, scenario planning and facilitating rapid and informed decision-making.
Requirements of Director, Program Management:
- BS or Advanced degree (Master’s, PharmD, PhD) preferably in life sciences/health-related
- 10+ years of pharmaceuticals/biotech experience, including at least 7+ years drug development experience in the pharmaceutical, biotech setting; Early (pre-IND) drug development experience desired. Biologics drug development experience desired.
- Demonstrated ability to plan, execute and complete complex programs.
- Demonstrated ability to successfully lead teams
- Excellent verbal and written communication skills
- Advanced organizational and/or project management skills
- Familiarity with general principles of GLP, GCP, GMP and ICH.
- Willing and able to be “hands on”, doing the day to day activities to build programs
- Experience in the compilation of an IND, BLA, NDA and/or MAA is a
- Proactive, “can do” attitude
- Ability to influence without authority
- Able to drive teams towards decisions
- Results-oriented; quality focused
- Resourceful self-starter
Responsibilities of Director, Program Management:
- Operational Lead for planning and execution of program objectives, ensuring that key program deliverables are met and results are delivered in line with timelines, cost and quality These duties include:
- Provide operational leadership on project teams and subteams.
- Attend weekly and monthly meetings and prepare agendas and summaries for these meetings.
- Work with the ED of PM to establish timelines that align with project team goals.
- Utilize standard PM tools to facilitate and enable rapid and informed decision making (e.g. Gantt charts, decision trees, scenario planning, risk assessment, Action/Decision tracking).
- Communicate delays and risks to the project team as well as develop risk assessments and solutions when needed
- Oversee global CMOs and other vendors and appropriate escalation of issues
- Establish cross-CMO communication plan to ensure consistency
- Monitor CMO/Vendor performance; identify issues and partner with leadership to develop appropriate action plans
- Identify issues and facilitate resolution of issues within and across programs
- Lead ContraFect’s internal subteams and actively facilitate team meetings as appropriate
- Contribute to budget planning in collaboration with Program Management and Finance
- Act as file steward for the Official ContraFect program files
- Support the ED Program Management with planning and execution of regulatory filings
- Manage and coordinate updates to granting organizations, including DOD and CARB-X at the direction of the Executive Director.
- Contribute to the development of SOPs, support inspection readiness and address quality issues that may arise, including development and implementation of Corrective and Preventative Actions if necessary.
- Present / provide, program updates to key stakeholders including ContraFect Chief Medical Officer, R&D Leadership Team and Executive Leadership Team (e.g. status reports etc…)
- Develop and maintain constructive working relationships with internal and external team members and respective project managers at granting organizations (e.g. DOD and CARB-X)
- Contributes to developing and implementing publication plans for key programs in collaboration with cross-functional teams
Respect. People matter.
Patient- Focus. Act with urgency and passion to save lives. Leadership. Set high standards, and empower others to do the same. Innovation. Challenge the status quo to deliver solutions.
Collaboration. Work together to achieve our vision.
Quality. Strive for excellence in all that we do.
Integrity. Courage to be honest, ethical, and transparent.
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