SVP R&D, Regulatory, and Medical Affairs

Company Overview

Bryn Pharma was founded by patients who are personally affected by anaphylaxis. The concerns of patients and caregivers like us have informed our approach. Our experience has fueled our drive to find A Better Way. Too many anaphylaxis attacks go untreated — or treatment is delayed — for two key reasons: first, because current emergency epinephrine devices rely on needles, which many people fear or aren’t prepared to administer; second, because many people simply don’t carry the appropriate dosage with them (or carry any dosage at all) because the current devices are too big and bulky. We are creating a practical solution to help our community address these challenges and better manage their daily lives with severe allergies.

If approved, NDS1C will be one of the first innovations to emergency epinephrine treatment in fifty years. Epinephrine is the only approved treatment for anaphylaxis. In the early 1900s, epinephrine was developed as a synthetic drug and became widely used in medicine. In the 1960s, doctors started prescribing patients at risk of anaphylaxis a vial of epinephrine and a syringe to manage the condition. In 1987, the FDA approved the first epinephrine autoinjector. For the last 35 years, the autoinjector has become the most popular treatment in outpatient settings. Today Bryn is working to innovate on this long-standing standard of care by developing epinephrine nasal spray.

• Provide executive assistant support to the CEO and various members of our leadership team, including internal and external parties, with a high level of professionalism and in a manner that positively reflects Bryn Pharma.
• Manage, organize, and sustain complex contact records, calendar(s), and c-suite events (e.g., offsite meetings, group private dining events, team building, executive leadership team meetings, etc.).
• Prepare agendas, reports, special projects, announcements, presentations and other documents in Word, Excel, PowerPoint in support of the leadership team.
• Arrange travel, accommodations, and itineraries for the CEO and leadership team as needed.
• Prepare and submit expense reports on a timely basis. Reconcile to ensure reimbursements are appropriately completed.
• Process invoices for payment, review expense reports for T&E compliance for leadership team and aid in preparation of quarterly and annual budget reviews, along with other financial presentations.
• Assist in HR processes, such as payroll submission, onboarding new employees, interview scheduling, job postings, HR system updates, and other activities as assigned.
• Lead office management responsibilities to include liaising with property management, managing office supply inventory and ordering, and setting up laptops and video conferencing systems, safety trainings, and the like.
• Be responsive to emails/texts/phone calls, with contact outside normal business hours.
• Assist in managing technology, facility, and security issues.
• Research vendors and pricing for various needs, such as business cards.
• Maintain documents and records in appropriate, retrievable files.
• Coordinate project planning activities and facilitate meetings to help ensure the team delivers against its commitments with the highest quality deliverables in a timely fashion.
• Assess existing processes and identify opportunity for improvement.

Position Overview

As part of the Executive Leadership team, the SVP of R&D, Regulatory and Medical Affairs will lead a team of internal and external partners in the overall Clinical Development, Regulatory Affairs, Pharmacovigilance and Medical Affairs functions. This individual will be responsible for leading the development and execution of all planned and future clinical studies, including identification of need, protocol development, CRO management, and other R&D aspects of the business. The individual will further refine clinical/medical structure and roles and responsibilities of the full team to include the internal team (Medical Affairs) and other fully outsourced teams in Regulatory Strategy, CRO, and CMC, to ensure successful and timely submission of NDS1C Epinephrine Nasal Spray, and any future assets.

Additional Responsibilities

• Lead development and execution of all planned and future clinical studies, including identification of need, protocol development, CRO management, etc.
• Partner closely with Manufacturing Operations and external contract manufacturing partner on LCM planning as it relates to formulation, device upgrades, packaging/labeling considerations, etc.
• Oversee Regulatory Affairs including managing existing partners and identifying the model/external partner who will manage post-approval regulatory needs and responsibilities.
• Manage IND and any necessary annual updates.
• Establish/outsource call center/ med Info/pharmacovigilance and adverse event reporting capability. Manage vendor to performance expectations on ongoing basis.
• Establish legal and compliant process for Investigator Initiated Trial and other grant request submissions and evaluations. Manage investigators to milestone expectations.
• Address all elements of IIT management, including:
  • Areas of Research Interest publicly posted on website.
  • Policy/SOP—Intake procedure, grant request review and approval, protocol assessment
  • Contract Template (Legal to supply) with milestone payment schedule.
  • Fair Market Value budget assessment (software or contract org)
  • Clinical Supplies management
• Establish process for all other grants (i.e., educational grants)
  • Areas of Educational Need publicly posted.
  • Policy/SOP—Intake procedure, grant request review and approval, grant closeout
  • Letter of Agreement template
• Create and execute SOP for Regulatory, Medical, Legal review processes for all promotional materials.

For this role you will need:

• MD degree with a strong track record in the medical device/pharma industry.
• At least 10 years of clinical development leadership experience in drug device, preferably in the Allergy and Asthma therapeutic areas or with inhaled delivery system products.
• Proven track record of leading clinical development programs from early-phase trials through regulatory submissions.
• Depth in understanding CMC guidance and protocols.
• Experience managing clinical CROs from RFP to statements of work to coordinating execution.
• Regulatory experience preferred, with experience in front of regulatory agencies.
• Knowledge in Pharmacovigilance, including the day-to-day medical monitoring of clinical trials.
• Strong communication and collaboration skills. The ideal candidate will have a network of external thought leaders within Allergy, who serve as advisors.
• Excellent organizational skills and ability to meet deadlines.
• Ability to see the big picture and pay attention to details.
• Hands-on, action oriented. Proactive in anticipating and addressing difficulties.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
• Ability to interact with transparency across the organization, and with external partners.
• Outstanding leadership and management capabilities to build, motivate, and manage a strong operational organization and serve as a leader within the full corporation.
• Broad business perspective to integrate clinical concepts as part of the overall corporate strategy.
• Willing to travel to support clinical and corporate activities.

Our offer to you:

By joining Bryn Pharma, you will be a part of a dynamic and energized team where you will be able to provide input into impactful decisions and be a part of shaping our company’s future. The skills and business insight you gain will serve as an invaluable foundation toward developing your career with us.

Our inclusive company culture brings unique perspectives and embraces diversity of thought. We actively seek to hire and develop the best and brightest team members from all backgrounds, ensuring our continued success into the future.

This role offers a competitive compensation and benefits package, as well as a unique opportunity for professional development and exposure as we build the organization from the ground up.