This an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas. We are in search of medical leadership to join our team to support multiple programs as well as an early stage portfolio.
In collaboration with the Clinical Development Lead, as well as other program functional area leaders, the Medical Director will support the clinical development program teams responsible for study design, development, execution, data readout, and summary. This position will also provide ongoing input into assessment and interpretation of safety data and contribute to investigator training.
What you'll dive into
Providing medical/clinical support and scientific opinion to study teams and functional areas such as regulatory, clinical development, and clinical operations.
Provides input to study design, protocol concepts/protocols preparation, statistical analysis plans, and reporting within assigned programs to yield high value clinical endpoint insight for future critical decisions.
Collaborates with external opinion leaders and Principal Investigators, as well as internal clinicians, clinical scientists, translational scientists, and clinical operations personnel to ensure appropriately designed studies are successfully implemented.
Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase 1-3 studies, managing the process from protocol development through study execution to completion of study reports and integrated regulatory documentations.
Directs the planning, preparation, writing and reviews of aggregate medical safety reports in coordination with the program's Pharmacovigilance/Safety lead.
Works with study and program teams to achieve program goals and provides deliverables in approved timeframes.
Supports the development of regulatory documents for filings and agency meetings
Reviews and interprets scientific knowledge of competitor landscape (molecule / indication)
Proactive identification of issues/problems and recommends solutions
Participate in preparation of prepare abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices, as well as therapeutic area knowledge to ensure consistent best practices across all activities
Maintains knowledge of ICH-GCP, external regulations and procedures - required for regulatory filing
What we expect
MD degree required with a cardiology specialty strongly preferred and/or related research experience. Dual degree; MD/PhD or PharmD/PhD strongly preferred
Preferred 4+ years of broad experience in industry/drug development and/or clinical research with cardiovascular therapeutic area.
Experience with medical monitoring
Ability to work with a high level of autonomy/independence
Strategic abilities and capability to take the lead and "ownership" of programs within specific indication areas
Ability to analyze and interpret clinical safety and efficacy data and develop written reports and presentations of those data
Very good IT skills
Availability to participate in early or late meetings/teleconferences
Able to manage priorities and competing demands in a changing work environment
Strong oral & written scientific communications skills
Good presentation skills for both internal and external audiences (investigator meetings as well as departmental meetings)
Ability to strike proper balance between independent work and team interaction; good team player in a cross functional team
Well-developed interpersonal skills, with experience in interacting with and influencing people, building strong positive relationships
Ability to travel up to 20%, including international travel
What you'll get
To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people's lives
Opportunities to learn and contribute creative solutions
Comprehensive health insurance
Matching 401k retirement plan
Paid time off and holidays including a Summer & Winter break
Arena celebrates and supports our differences and is proud to be an Equal Employment Opportunity and Affirmative Action Workplace. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Arena is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance due to a disability, you may contact us at firstname.lastname@example.org.
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