Medical Director/Sr. Medical Director
This is a key leadership role at a growing, fast-moving privately held biopharmaceutical company.
The Sr./Medical Director will be responsible for providing medical/clinical leadership for Spruce Biosciences’ clinical development programs, and for the design, execution, and analysis of clinical trials, as well as for supporting medical monitoring activities across all trials. The right candidate should have prior biotech/pharma experience in leading early- and late-stage clinical development programs through NDA/MAA filing.
The Sr./Medical Director will report to Spruce’s Chief Medical Officer.
· Lead in the planning, development, execution and analysis of clinical development programs in rare endocrine disorders
· Collaborate closely with outside vendors, academic institutions, and key opinion leaders
· Provide medical management/supervision of CROs, vendors, and consultants
· Develop clinical study protocols and author/review investigator brochures, clinical study reports, and other clinical trial-related documents
· Provide clinical guidance and leadership to support successful regulatory interactions with FDA and ex-US agencies
· Partner closely with clinical operations and/or medical affairs to drive the timely enrollment of clinical studies
· Serve as medical monitor to ongoing clinical studies by providing medical expertise for any clinical issues that arise, reviewing/analyzing clinical data on an ongoing basis, and preparing the safety analyses/regulatory submissions for any required adverse events.
· Partner effectively with nonclinical/DMPK, clinical pharmacology, regulatory affairs, clinical operations, biostatistics and medical affairs to ensure sound clinical, scientific, and strategic input into development program.
· Provide expertise on statistical analysis planning and lead in the analysis and interpretation of clinical data in conjunction with the biometrics team
· Actively participate in, or lead investigator meetings and site initiation visits with clinical trial investigators and study personnel
· Represent the company at scientific meetings, patient advocacy events, and other public relations opportunities, as directed by the CMO and/or CEO
· Provide medical leadership and support for publication of data (manuscripts, abstracts posters, presentations, etc.)
· Develop meaningful and credible partnerships with key opinion leaders
· Medical degree (MD or MD, PhD)
· Board certification/eligibility in a relevant specialty: Adult or Pediatric Endocrinology, Internal Medicine, etc.
· 5-8+ years of experience in a biotechnology/pharmaceutical company with relevant experience leading drug development (early stage clinical development through approval) including clinical study design/conceptualization, trial execution, and successful regulatory approvals with US and ex-US regulatory agencies (INDs, NDAs, BLAs, MAAs, etc.)
· Expertise and consistent success in clinical research and/or clinical practice (as evidenced by appropriate higher qualifications, publications, and/or relevant specialist accreditation)
· Clinical development experience in rare, orphan indications
· Proven history of fostering strong collaborations with internal stakeholders at all levels, including clinical operations, biometrics, nonclinical research, regulatory affairs, medical affairs, and drug product development
· Demonstrated success in influencing key external stakeholders (key opinion leaders, investigators, researchers) including presenting/responding to the FDA and ex-US regulatory authorities
· Understanding of global pharmacovigilance requirements and guidance documents and ability to influence decision making around complex multifaceted issues involving medical safety
· Outstanding leadership skills and ability to thrive in a fast-paced, dynamically changing environment
· Excellent strategic planning, organizational, and communication skills
· Highest level of scientific and medical integrity
· Proficient in the use of industry-standard software (eg. Microsoft Office Suite, WebEx, electronic data capture systems, etc.)
· Working knowledge and understanding of data analysis software (Excel, SAS, R, etc) and data presentation
· Willingness to travel (~20-25% time) including internationally
Spruce Biosciences is a venture-backed clinical-stage biopharmaceutical company based in San Francisco. At Spruce, we are committed to developing novel therapies for rare endocrine diseases, starting with our lead product candidate for the treatment of congenital adrenal hyperplasia