Position SummaryLycia is seeking a highly motivated, innovative, and collaborative clinical development leader to join our team in advancing our pipeline of LYTAC degraders and help establish Lycia as the industry leader in endosomal-lysosomal degradation and delivery. The successful candidate is expected to have a strong drug development track record of advancing programs from early through mid- and late-phase clinical development.
The candidate will be expected to drive the study design, study implementation, data analysis, safety monitoring of mid- and late-phase clinical trials in close partnership with early phase / translational development group and the research organization. The successful candidate will be instrumental in providing medical leadership and expertise to help guide the direction and actively support the advancement of our pipeline.
The candidate will have a strong background in medicine, recognized expertise in their therapeutic area and strong leadership abilities, and a passion for driving innovation and excellence in a start-up biotech company. The role will report to the Chief Medical Officer.
Primary Responsibilities:- Lead the development, execution, and interpretation of mid- to late-stage development plan in close collaborative partnership with early development / translational leader, cross-functional representatives, and research group to support clinical development and/or regulatory approval.
- Provide oversight of medical monitoring of clinical trials in partnership with CRO representatives and consultants to ensure pharmacovigilance and safety-related activities are appropriately managed according to GCP and regulatory guidelines in a timely manner.
- Provide medical support related to the development of medical and/or relevant scientific sections of clinical study and/or regulatory documents (e.g., study protocol, investigators brochure, informed consent forms, clinical study reports, statistical analysis plans, safety updates / annual safety reports, responses to Health Authorities and/or Ethics Committees / Institutional Review Committees). Participate in safety monitoring boards (e.g., Data Safety Monitoring Boards) as needed.
- Ensure compliance with regulatory requirements and guidelines throughout the product lifecycle, including interactions with regulatory agencies and participation in development of regulatory documents for submissions to Health Authorities.
- Contribute to the development and execution of program strategic plans and initiatives to maximize the value and impact of our portfolio.
- Collaboration with the Lycia Executive Committee members, early development / translational medicine leader, internal cross functional team members, as well as partner with contract research organizations (CROs), investigators and study site staff, and external consultants to advance multiple drug candidates, including into mid- and late-stage development.
- Working with cross-functional teams to develop program relevant documents (e.g., target product profiles, materials for internal governance, board meetings, publication planning material, advisory board documents) as needed to support program initiatives.
- Provide clinical and scientific leadership and guidance to internal teams and external stakeholders, including investigators, key opinion leaders (KOLs), and scientific advisors.
- Partner with the CEO, CMO, program and/or functional leads, on behalf of clinical development leadership, the planning and execution of advisory boards with external KOLs, in close coordination with the early translational medicine leader
- Build and maintain effective relationships with key external stakeholders, including healthcare providers, patient advocacy groups, and professional societies.
- Lead project teams in the successful implementation of key clinical development programs to ensure that program timelines and budgets are met.
- Ensures timely, clear, and accurate communication and interpretation of study results to facilitate productive discussion and effective decision making.
- May serve as the company representative or subject matter expert in meetings with external stakeholders (business partners/collaborators, vendors, investigators, regulatory agencies, patient advocacy organizations, payers).
- Member of clinical and scientific leadership team that will work effectively and collaboratively with other departments and cross-functional teams, and contribute to building a positive, team-oriented culture.
- Contribute to the pipeline strategy, including input on program prioritization, portfolio trade-offs, and organizational build-out of the clinical development function as Lycia scales.
Qualifications:- MD or equivalent with training/experience
- Minimum of 15+ years of clinical development experience; small to midsize biotech company experience strongly preferred.
- Proven track record of leadership in the successful development and implementation of Phase 2 and Phase 3 clinical trials to support regulatory submission (e.g., BLA, NDA).
- Experience in writing clinical sections of regulatory documents and direct interaction with the FDA/health authorities. Strong knowledge of nonclinical drug development, FDA, and ICH guidelines and GCP regulations; experience in NDA and/or BLA submissions is preferred.
- Experience in supporting identification, working with and oversight of CROs and vendors a track record of timely and successful delivery of clinical studies.
- Experience collaborating and managing consultants.
- Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations.
- Demonstrated ability to translate strategy into action. Excellent analytical skills, ability to communicate complex issues in a simple way, and ability to orchestrate plans to resolve issues and mitigate risks.
- Demonstrated ability to build and lead high functioning, collaborative and driven teams (both internal and external), and mentoring direct reports and/or junior cross-functional colleagues as applicable.
- Ability to build trust and strong collaborative relationships with both internal and external stakeholders.
- Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with other clinicians, scientists, managers, peers, and staff.
- Outstanding organizational and interpersonal skills, and outstanding ability to manage relationships and influence others.
- Excellent strategic thinking, problem-solving, and analytical skills
- Excellent written and verbal communication skills.
- Experience in immunology & inflammation and autoimmune indications, preferred.
- Willingness to be both a strategic leader, critical thinker, and hands-on problem solver and willing to operate and execute at all levels.
- Strong ability to communicate and establish effective working relationship with external stakeholders (e.g., investigators, collaborators, scientific advisors, CROs, and corporate partners).
- Able to work in a small, nimble organization across key functions.
- Highly organized and detailed oriented.
- Prepare and attend internal governance meetings.
- Make meaningful contributions to business development related activities as needed.
- Willingness to travel up to 15% of the time.
$360,000 - $420,000 a year
The expected base salary range for this role is $360,000-$420,000. We encourage candidates of all levels to apply as there is often flexibility on job title and responsibilities. Compensation will be based on a variety of factors, including experience, qualifications and internal equity. Lycia offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
