Sigilon Therapeutics is seeking an experienced and energetic individual to lead all aspects of the execution and management of Phase 1-4 clinical trials in rare diseases. The successful candidate must have excellent communication skills and the ability to work independently in a highly interactive and fast-paced environment.

Responsibilities:

• Manage all aspects of CRO/vendor selection, including request for proposal, CRO evaluation and selection
• Manage all aspects of clinical trials from study start-up to close-out while adhering to FDA, EMEA, GCP, and ICH guidelines
• Oversee CRO and vendor activities, including day-to-day management as well as review of metrics/key performance indicators (KPIs)
• Participate in start-up activities to ensure efficient and accurate study timelines and timely site activation
• Serve as a point of escalation for study teams and CROs
• Review and contribute to authorship of clinical study protocols, informed consent forms (ICFs), study manuals, clinical study reports (CSRs) and other clinical documents, as necessary
• Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationship
• Attend monitoring visits as needed
• Effectively communicate and interact with Key Opinion Leaders
• Collaborate with the cross-functional team at Sigilon to ensure close communication and accurate planning for upcoming and/or ongoing studies
• Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings
• Facilitate risk assessment planning and timely resolution of issues
• Participate in Case Report Form design, user acceptance testing in partnership with the CRO
• Ability to travel (~ 20%) post COVID

Requirement/Qualifications:

• Bachelor’s degree in life sciences or healthcare related field
• At least 5 years clinical research experience in a CRO or pharmaceutical company, with at least 3 years direct experience managing complex, international studies
• Experience in gene and cell therapy product and/or rare disease is desirable
• Proven experience overseeing CROs and managing all operational aspects of clinical studies
• Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close-out procedures
• Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations as required
• Experience working closely with study sites, Key Opinion Leaders (KOLs) and external vendors
• Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
• Proven ability to work independently, take initiative, and effectively handle multiple priorities
• Excellent interpersonal/team skills, strong organizational skills
• Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required

Sigilon Therapeutics is seeking a proven leader with expertise in pharmaceutical/biotechnology quality assurance, excellent communication skills, and the ability to work independently in a highly interactive and matrixed environment. The incumbent will serve as integral member of the Quality Group, focusing on oversight of Contract Manufacturing Organizations (CMOs), leading vendor audits, review approval of batch records for drug substance /drug product, and Certificate of Analysis/Testing/Compliance (CoA, CoT & CoC). This role will require daily interaction with stakeholders including but not limited to CMC Analytics, Biology, Clinical Operations, Contract Manufacturing Organizations (CMOs), Clinical Research Organizations (CROs), and External Testing Laboratories.

Presentation of written and oral summaries of progress in team meetings as well as to management is expected. Supporting Quality initiatives as well as leading and participating in Quality projects as required.

Responsibilities:

• Vendor Management and Oversight
  1. Qualification of prospective vendors in accordance with Sigilon GMP tiering; questionnaires, assessments in collaboration with stakeholders.
  2. Preparation, negotiation, and execution of vendor quality agreements
  3. Independently manage quality oversight for multiple programs at multiple CMOs concurrently
  4. Vendor audits: schedule, lead vendor audits, prepare audit reports and follow up on audit findings.
  5. Initiation, tracking, and approval of CMO non conformances, manufacturing/testing CAPAs, and audit related corrective actions
  6. In collaboration with internal stakeholders track vendor performance, create KPIs, metrics, and provide updates to senior management on an ongoing basis.
• Quality Management System (QMS) Documentation Oversight and Compliance
  1. Collaborate with cross functional teams and outside contractors to ensure that relevant Sigilon computer systems are compliant with global regulations including but not limited to FDA 21CFR Part 11, GAMP5, EU Volume 4 GMP Annex 11: Computerized Systems. Assist in development and review of Computer System Validation (CSV) documentation.
  2. Oversee tech transfer implementation of QMS processes and procedures related to CMOs
  3. Liaison between CMO and Sigilon for training needs and compliance
• Internal Audits
  1. Prepare, conduct, and produce reports for process audits of key Sigilon departments and workflows on a scheduled basis to confirm compliance with the established SOPs
  2. Such audits include but are not limited to CMC Analytics, Biology, Engineering, IT, Manufacturing. Ensure all findings are resolved effectively in a timely manner.

Requirements

• B.S./B.A. Degreein scientific discipline, with 8+ years of previous experience in quality assurance and systems in an FDA regulated or similar environment preferred.
• Demonstrated Computer System Validation (CSV) operational expertise and experience.
• Demonstrated vendor management, auditing operational experience
• Experience with electronic document management systems, quality management systems, and electronic learning management systems (LMS). Working knowledge of relevant industry and government regulations including: 21 CFR 11. cGMP, GDP, CFRs, Annex 13, ICH E6 (R2). Uses industry knowledge to drive best-practices within company
• Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams
• Understand comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, CFRs, Annex 13, ICH E6 (R2), etc)
• Experience in interacting with Health and Regulatory Authorities (e.g. inspections)
• Experience in deviation investigation and CAPA implementation
• Possess a strong attention to detail and have exceptional interpersonal, organizational and communication skills
• An energetic self-starter who is adept at multi-tasking, has a track record of productivity and capable of working both independently and as part of multiple collaborative teams
• Ability to prioritize responsibilities to meet project deadlines and flexibility to react quickly to changing research needs

• Travel up to 25% (post-covid)

• Special considerations:

Candidate must possess effective communication skills, and proven abilities in interfacing with colleagues in several different departments and managing multiple projects/priorities. Must be methodical, well organized and detail oriented. Individual must be highly self-motivated, readily adaptable to a fast-paced, multidisciplinary team-based environment and capable of working autonomously with little direct supervision

Sigilon is a clinical-stage biotechnology company pioneering a new class of therapeutics and seeking to develop functional cures for patients with chronic diseases by providing stable and durable levels of therapeutic molecules to patients. Sigilon has developed its Shielded Living Therapeutics, or SLTx,platform, which combines advanced cell engineering with cutting-edge innovations in biocompatible materials and enables our product candidates to produce a wide range of therapeutic molecules that may be missing or deficient, such as proteins, antibodies and hormones. The company is designing product candidates to be off-the-shelf, durable, controllable and redosable, without requiring modification of the patient’s genes or immunosuppression. The lead product candidate, SIG-001, is designed to prevent bleeding episodes in patients with moderate-severe to severe Hemophilia A by continuously secreting human FVIII. The company received acceptance of its IND submission in the United States in August 2020 and its CTA in the United Kingdom in May 2020. Sigilon initiated a Phase 1/2 clinical study of SIG-001 in Hemophilia A, with the first patient dosed in October 2020.

Job Summary:

The Senior Director/VP, Investor Relations is an important leadership role at Sigilon Therapeutics. This person will report to the Chief Financial Officer and work closely with the CEO and senior management team. S/He will have overall responsibility for shaping the investor communication strategy, manage interactions with buy-side, sell-side and other constituents, with the aim of increasing shareholder value and enhancing Sigilon’s image in the investment community.

Key Responsibilities:

• Work closely with the senior leadership team on the development, integration and execution of the investor relations strategy
• Create and manage a targeting strategy for prospective investors; establish and nurture close relationships with key investors and Wall Street analysts
• Track Wall Street analysts’ models, estimates, and pipeline expectations
• Continual refinement of messaging and market positioning based on company performance, market perception, expectations, peer performance and relative valuation
• Partner with senior leadership and work cross-functionally to support specific investor relation activities and creation of investor communications and events including analyst days, scientific meeting investor events and other investor focused communications
• Originate and maintain investor-facing materials, including all press releases, investor presentations, conference call scripts, Q&As, IR website and backgrounders
• Work in close partnership with internal legal team to review IR-related external communications and related 8-K filings
• Maintain master investor list and target communication lists; Track all investor interactions
• Prepare executive management for investor events and earnings calls; Accompany and support senior executives at investor conferences and be a resource for information; Own and prepare investor presentations and key investor messages by working with multiple functional groups
• Keep abreast of industry trends and competitive landscape to both proactively and reactively adjust plans, messaging and manage relationships that may be impacted

Qualifications:

• 6+ years’ experience in the life sciences industry with a focus on investor relations, finance, equity research or investment banking
• MBA and experience in the life sciences industry /or advanced science degree preferred
• Experience successfully evolving an investor relations strategy as necessary for a rapidly growing and expanding business
• Existing relationships within the financial, industry analyst, media, and institutional investor communities particularly in life sciences
• Capable of independently writing clear, concise and error-free documents; Develop complex documents such as press releases, external company presentations, annual/quarterly reports.
• Impeccable integrity and judgment skills, ability to deal with sensitive financial information and make recommendations to the CEO and CFO
• A proactive, strategic approach to investor relations; Proven ability to plan, organize and execute IR-related events
• Exhibit excellent verbal, interpersonal communications, and business writing skills
• Possess a strong work ethic, be a self-starter, and be able to be highly productive in a dynamic, collaborative environment; Strong attention to detail and ability to be tactical and strategic