Senior Medical Director, Clinical Development-(Nephrology)

Remote
Clinical Development – Clinical Science /
Full time /
Remote
Alpine Immune Sciences is a leading clinical-stage biopharmaceutical company dedicated to discovering and developing innovative, protein-based immunotherapies for autoimmune and inflammatory diseases. Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges. Join us!


The Senior Medical Director will oversee the direction, planning, execution and interpretation of clinical trials and data collection activities for multiple programs in the development portfolio.  The individual in this role will establish and approve scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Together with the Clinical Trial Manager, may recruit clinical investigators and negotiate study design and costs. They will be responsible for directing human clinical trials, phases I – IV, for company products under development. Responsibilities also include adverse event reporting and safety responsibilities monitoring. Coordinates and develops information for reports submitted to the Food and Drug Administration and other health authorities. Monitors adherence to protocols and determines study completion. May act as consultant/liaison with other corporations when working under licensing agreements.
 
Duties and responsibilities:
 
Provide medical monitoring to multiple clinical trials.
Lead project teams to design and implement clinical studies.
Write protocols, investigator brochures, clinical study reports and review clinical trial documents.
Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
Translate findings from research and nonclinical studies into clinical development opportunities.
Interact with clinical investigators and thought leaders.
Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry and ensure compliance with these external guidelines.
Work with internal pre-clinical scientists, translational scientists, safety physicians, business, and commercial organizations in a cross functional manner.
Work in a team environment comprising clinical operations, biomarker specialists, CROs, and regulatory affairs.
Perform other duties as required.
 
Qualifications:
 
M.D. with board certification or eligibility in Nephrology is required.
At least 3+ years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience.
Proven clinical development strategist with experience designing, implementing, and conducting clinical trials.
Knowledge of carrying out clinical trials, including knowledge of current treatment landscapes; experience with clinical trials in systemic lupus erythematosus useful
Strategic leadership and tactical skills, excellent initiative, and judgment, and demonstrated ability to positively represent the goals of Alpine.
Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigators.
Demonstrated ability to work well in teams in a cross functional manner.
Ability to communicate and work independently with scientific/technical personnel with excellent oral presentation skills.
Ability to think critically and demonstrated troubleshooting and problem-solving skills.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
Anticipated up to 25% travel.

#LI-Remote
At Alpine we engage equitable workplace strategies to ensure fair compensation. Actual compensation is dependent upon current market data, experience, and pay parity within our organization. This position is a Senior Medical Director level position, with a compensation range of $315,000 - $350,000. Note that there is a strong preference for candidates to be located in one of the following five states: CA, MA, NC, OR, or WA. We take care of our employees with a competitive benefits package that includes stock options, annual bonus, premium medical, dental, and vision coverage for employees and their dependents, as well as life and disability benefits, FSA, and 401(k) plans. We believe quality time outside the office is vital to our employees’ satisfaction at work, so our flexible PTO plan of 160 hours, generous holiday time (generally 12 days), and parental benefits encourages team members to take time off so they can come back refreshed. Alpine team members enjoy competitive salaries and equity participation (stock options).

Alpinists share a passion for meaningful work and are committed to solving the most complex problems in immunology to create new therapies for patients. We believe in innovative thinking, collaboration, flexibility, bias for action, and healthy debate. To foster our team of outstanding scientists and business professionals, we provide a premier work environment with a state-of-the-art lab and office spaces with truly inspiring views, and an open design to facilitate teamwork.

Our treasured culture has been shaped by our diverse team who truly enjoys working and playing together. We nurture Alpine’s culture in many ways, including all-company social events and happy hours, lunch-and-learn and education opportunities, interest groups like book club and movie nights, peer-to-peer recognition programs, a robust wellness program to help support physical, mental, and emotional health, and more.

Alpine is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Alpine is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Our office and lab are located in the blossoming biotech neighborhood of Eastlake in Seattle. Alpinists enjoy the flexibility to work onsite, remotely, or a hybrid schedule, with evolving options as we prioritize keeping Alpinists safe and healthy. Onsite employees enjoy an open-office layout with comfortable huddle rooms and Zoom Room-enabled conference rooms, a spacious breakroom and kitchen with a coffee bar and snacks, and rooftop access to enjoy gorgeous views of Lake Union and Gas Works Park.

Exciting challenges lie ahead—guided by our core values, we’ll meet these challenges.  Join us!