VP, CMC Commercial Strategy

FLSA Classification : Exempt/Salary 

Schedule: Monday to Friday; 8:00 am to 5:00 pm  

Department: Chemistry, Manufacturing, Control - US 

Reports to: Senior Vice President, CMC  

Supervisory responsibilities: Yes 

Location: Fully Remote 

Position Summary/objective: 

The Vice President, CMC Commercial Strategy will be accountable for CMC activities related to the development of the commercial capabilities within Immatics leading to launch of IMA203 and future cell therapy portfolio.  

This position will design and build the CMC commercial organization and will partner cross-functionally to guide planning and execution of commercial readiness for the entire cell therapy supply chain (not only CMC critical raw material but also activities related to the manufacturing and distribution of cell therapies across the patient journey). 

This position effectively collaborates with the Commercial, R&D, BD/legal, procurement, technical operations and other relevant parts of the organization to ensure various supply agreements are in place for any raw material necessary for the commercial manufacturing of cell therapy drug products. The position will be also responsible for the distribution for Immatics Bispecific drug products (TCERs) and related co-medications. 

Essential functions: 

Managerial and Leadership Functions 

• Act as a role model for team members with respect to earning their trust by your own attendance, keeping your word, personal behaviors, transparent/frank communication, and execution of personal assignments.  

• Hire team members that will fit the job, company culture and team dynamics. 

• Distribute work appropriately among team members. 

• Organize and manage team members time/schedules and assignments, keep track that team members are utilizing their time in meaningful assignments that will move the company forward. 

• Communicate frequently and regularly with team members assuring they have the information and tools to perform their functions. 

• Resolve conflict between team members if any arises – be an active listener of your team members.  

• Set goals, measure achievement progress, and assist team members in successful execution of their / team goals as well as coach and help develop team members into higher roles at Immatics if they so desire.  

• Provide regular, meaningful (honest but emphatic) performance feedback, expertise, and coaching (5:1 positive to negative ratio) that will help team members grow and develop. Turn feedback into coaching moments and show your willingness to be a partner in team members career development at Immatics.  

• Reward and give credit to team members when they so deserve – publicly and privately.  

• At the same time, coach team members on the spot if corrections are needed (privately). Provide psychological safety to team members if they make mistakes but expect mistake corrections and improvements.  

CMC Commercial and Patients Supply Functions 

• Lead planning for the CMC activities related to commercial launch of IMA203 and future cell therapy products. 

• Responsible for the onboarding and maintenance of clinical sites and hospitals necessary for the commercial supply of Immatics cell therapy portfolio. 

• Responsible for the supply of Immatics cell therapy products and comedications to hospitals and clinical sites throughout the patient journey during clinical trials and commercial operations. 

• Identify and manage the procurement of the CMC material necessary for the successful commercial manufacturing of IMA203 and future Immatics cell therapy portfolio. 

• Work closely with the technical operations group to ensure all critical raw material are ready for procurement from various vendors. The technical operation group will be responsible for the stocking and storage of all procured material.  

• Lead the planning of commercial manufacturing as per commercial launch requirements and prepare for necessary expansion at current of future Immatics manufacturing sites. 

• Actively partner with internal CMC stakeholders (e.g. PD& AD, and GMP manufacturing) as well as external stakeholders (e.g. Commercial, GQO) to provide updates on the various raw material needed. 

• Identify opportunities to enhance commercial success by contributing to digital technologies that create value for commercial / on market stakeholders through collaboration with Immatics departments including but not limited to Manufacturing, IT and Clinical Operations.   

• Continually assess and improve the company’s set up to support the unique journey of patients that are being screened for and treated with autologous TCR engineered cell products as part of early and late-stage clinical trials as well as in the post-approval setting. 

• Initiate and manage external vendor relations including contracts, CDAs, supply agreements for all GMP manufacturing and QC release material.  

• Interface with senior management members to present CMC portfolio strategy considerations through active membership in Development Review Board (DRB).  

• As a member of the VP/SVP leadership team, partner to define and advise on company CMC portfolio strategy, driving clarity for strategic decision making in terms of manufacturing technologies.   

• Support partnering and integration of external innovations in the field of CMC and manufacturing by identifying opportunities to enhance commercial success and introduction of new technologies.  

• Manage the onboarding and maintenance of hospitals and other sites responsible for patient enrollment for Immatics Bispecific (TCER portfolio) including future commercialization efforts. 

• Responsible for the storage, and distribution of Immatics TCER products and comedications to various clinical sites. 

• Optimize the patient journey by collaborating with various stakeholders in the supply chain. 

• Position Immatics in the top league of players in operational delivery of our cell therapy portfolio to patients relative to the external competition and measurable key performance indicators. 

• Assist in the planning for the CMC Departmental Budget and own the GPS Budget. 

 Secondary functions: 

• Perform hiring and capacity planning for CMC commercial strategy and patient supply departments. 

• Provide the regulatory knowledge necessary for procurement of GMP material in various geographical regions. 

• Provide competitive intelligence on new technologies or GMP raw material that can be utilized to ensure competitiveness of mmatics ACT products. 

• Assist keep Immatics ACT products at lower COGs. 

Competencies: 

• Excellent communication and interpersonal skills. 

• Excellent organization skills. 

• High proven technical and/or business competence and significant experience in process, product, and assay development. 

• Result- and solution-oriented rather than problem-painting. 

• Ability to deliver department/function and company objectives. 

• Ability to coordinate the development and implementation of performance goals for a department/function. 

• Ability to lead and execute self-sustainably with minimal oversight. 

• Ability to lead self and others, accountable for own role and the role and operations for respective department(s). 

• Ability to provide information and context internally and externally in an impactful fashion including in a concise fashion. 

• Potential to inspire other team members from own and other functional lines. 

• Ability to understand/anticipate need of receiving internal or external party rather than presenting own capabilities. 

Work environment: 

This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.  

 Physical demands: 

• Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly. 

• Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds. 

• Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.  

• Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).  

• Sitting – remaining in a sitting position for at least 50% of the time. 

• Standing/Walking - remain on one's feet in an upright position at a workstation.  

 Travel required: Occasional travel (domestic and international) for conferences, vendor sites, retreats, team meetings and other company functions as needed. 

  Required education and experience: 

• Master’s in biology or related scientific or engineering field 

• Ten (10) years of related technical experience with direct work experience in clinical or commercial drug product activities such as GMP manufacturing, in-process testing, product development. 

• Previous industry experience in a biotech or pharma company. 

• Robust understanding of cGMP requirements and ICH/GCP and other relevant regulatory guidance. 

• Industry experience with commercial supply of autologous cell therapies   

• Excellent writing skills as they relate to preparation of product development reports.  

• Excellent interpersonal skills with strong oral/written communication and presentation skills. 

• Well versed in the latest trends in cell therapy product development.  

Preferred education and experience: 

• Doctoral degree in biology or related scientific or engineering field 

• Demonstrated success within manufacturing or process development. 

• Well versed in reviewing and analyzing in-process, finished product and stability data for trending. 

• Understanding of industry trends and leading methodologies. 

• Exceptional expertise and working knowledge of cGMP guidelines and knowledge of Quality System that meets global regulatory expectations. 

  Work authorization/security clearance requirements: