VP, Clinical Development

Watertown, MA
Full Time
Executive
About Affini-T Therapeutics
 
Affini-T Therapeutics is a clinical stage biotechnology company focused on building a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop solid tumor therapies. Through the application of gene editing and synthetic biology, we focus on enhanced T-cell fitness to overcome the immunosuppressive tumor microenvironment.

Job Summary
 
The VP Clinical Development leads the clinical development for Affini-T’s pipeline, incorporating medical, scientific, regulatory, and commercial perspectives into Affini-T’s strategy. This includes the key responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that is planned to ultimately result in the regulatory approval of Affini-T’s cell therapies in multiple regions as well as inform the value dossiers required for reimbursement.

The successful candidate will lead a multi-disciplinary team to advance Affini-T’s TCR-engineered T cell therapies into the clinic and through clinical development and will set the strategic direction for Affini-T’s clinical pipeline. He/she will be driven by creating value for patients and will inspire and motivate others to do the same. Collaboration with his/her clinical team, the VP Discovery, VP Precision & Translational Medicine, VP Preclinical, Head of Regulatory, CSO, CTO and CMO is critical to ensure alignment on portfolio priorities and ensure that resources are managed appropriately to advance programs to key inflection points.

The VP Clinical Development is a key leader who will work with Affini-T’s world-renowned scientific founders to align and take novel TCR-engineered T cell therapies into clinical testing. As such, they must have developed expertise in and understanding of the pharmaceutical industry in general with depth and breadth of knowledge within both cell and gene therapy and clinical trial conduct.
 
Essential Duties and Responsibilities

The major tasks for this position are as follows:
  • Establishes and drives Clinical Team strategy and deliverables
  • Lead efforts of Clinical Development function including Clinical Operations, Clinical Science, and Biostats
  • Works with the preclinical and clinical teams to deliver an innovative TCR-engineered cell therapy pipeline from IND to successful early clinical proof-of-concept and beyond
  • Leads the generation of the Clinical Development Plan and Clinical Trial Protocols
  • Drives high quality and speedy data generation on our clinical trials
  • Recommends and influences all aspects of our clinical programs including the scope, complexity, and size of the budget
  • Provides continual evaluation of the Asset Strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, including proactive identification of challenges, as well as the development of contingency plans
  • Builds strong scientific relationships with trial investigators, Key Opinion Leaders (KOLs) and other stakeholders in the field
  • Identifies, partners, and collaborates with clinical KOLs and investigators for clinical study design and implementation
  • Drives clinical science activities relating to the preparation / approval of synopses, protocols, and the conduct of clinical studies
  • Accountable for the successful design and interpretation of clinical studies
  • Responsible for executing and overseeing medical monitoring activities, pharmacovigilance, dose efficacy/safety assessment and RP2D
  • Directs clinical activities involved in interactions with regulatory authorities / agencies
  • Oversees CRO work on clinical trials, in collaboration with clinical operations
  • Supports identification and evaluation of potential business development opportunities, diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities
  • Maintains project timelines with input from functional departments and scientific project leaders, ensuring that project timelines align with corporate goals
  • Responsible for creating and communicating a clear vision and strategy for clinical cell therapy pipeline directed towards establishment and progression of an industry-leading TCR-engineered cell therapy portfolio
  • Ensures success of external collaborations by providing appropriate collaborative support within the Company and by serving on internal and external governance and decision-making bodies, as appropriate
  • Maintains a strong network and keeps up to date with developments in the field (e.g., competitive landscape across cell therapy R&D, emerging new biology / targets, partnership opportunities, regulatory guidance etc.)
  • Represents Affini-T’s clinical programs to diverse audiences including FDA or EMEA, shareholders, corporate partners, Board of Directors, and other key stakeholders

Desired and Required Qualifications

Education and Experience:
  • MD or MD/PhD
  • At least 10 years of work experience in running clinical trials and at least three years in cell therapy
  • Biopharmaceutical industry required. Demonstrated experience leading clinical development efforts and clinical teams in Cell Therapy Oncology, for both early and mid to late-stage therapeutic programs
  • Experience leading a clinical development function including clinical development, clinical operations, biostatistics/data management, and clinical science groups
  • Thorough understanding of relevant fields ranging from Cellular Immunology, Cell & Gene editing in the context of Oncology
  • Proven record leading multi-disciplinary Clinical Cell Therapy programs as evidenced by IND filings, early / late development program progression (Biotech or Biopharma/Pharmaceutical, or in partnership with academic institutions
  • High degree of familiarity with regional/global regulatory guidelines and interaction with regulatory agencies. Working knowledge of ICH and GCP
  • Highly creative, collaborative, and thrives in a dynamic matrix environment
  • Proven skills as an effective team player who can engender credibility and confidence within and outside the Company
  • Demonstrates leadership behaviors, presence and confidence while independently managing workload, team and conflicting priorities
  • Shows cross-cultural understanding and the ability to leverage diverse talents to maximize organizational productivity
  • Excellent oral and written communication skills, including writing, reviewing, and editing scientific, clinical, and regulatory documents and presenting to a range of stakeholders
  • Solid ability to build strong relationships and collaborate effectively with other teams
  • Forward thinking with the ability to recommend, influence and implement change and continuous innovation; comfortable challenging the status quo and bringing forward innovative solutions
  • Fit with Affini-T core values, mission, vision, and leadership principles, including the highest personal values and ethical standards, creating a culture that fosters innovation
  • Periodic travel required (e.g., scientific conferences, clinical trial sites)
  • The successful candidate will demonstrate agility, curiosity, positivity and results-oriented mindset, and the ability to balance leading and rolling up their sleeves to “get things done
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