Careers

Purpose of Role:

The Medical Director is responsible for the development of clinical research strategies and direction of Phase 1-3 clinical studies while working with cross-functional project teams. S/he will be responsible for study design, development, data readout, and summary. This position will also provide ongoing input into assessment and interpretation of safety data and contribute to investigator training.

This is not a remote position and is onsite at the Viking San Diego office.

Key Tasks & Responsibilities:

• In-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
• Provide clinical/scientific 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.
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral form.
• Must possess sound scientific and clinical judgement with ability to properly interpret clinical trial data.
• Collaborate with external opinion leaders, Principal Investigators, and clinical operations personnel to ensure appropriately designed studies are successfully implemented.
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics.
• Support the development of key scientific relationships with external opinion leaders and make scientific presentations at advisory boards, key scientific meetings and external committee meetings.
• May serve as Medical Monitor responsible for the safety monitoring of clinical trials, and as the medical expert for clinical studies.
• Participate in preparation of abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections).
• Conduct medical assessment and disposition of adverse events (in conjunction with Drug Safety Physician) and evaluate safety of clinical compounds prior to and during ongoing clinical studies.
• Provide periodic status updates and effectively communicate with Senior Management Team.
• Support the development of regulatory documents for filings and agency meetings and participate in interactions with regulatory agencies.
• 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.

Education:

• MD degree with accredited residency training and board certification in relevant clinical specialty for the therapeutic area required.

Professional Skills & Experience:

• 2 to 10 years experience in pharmaceutical and/or biotechnology industry developing investigational new drugs or experience in a clinical research organization involved in clinical trials.
• Experience with drug development in metabolic diseases (experience or knowledge of orphan disease drug development a plus).
• Ability to analyze and interpret clinical safety and efficacy data and develop written reports and presentations of those data.
• Ability to work with a high level of autonomy/independence.
• Able to manage priorities and competing demands in a rapidly changing work environment.
• Review and interprets scientific knowledge of competitor landscape (molecule / indication).
• Proactive identification of issues/problems and recommends solutions.
• Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience with FDA and other health authorities strongly desired.

Skills and Attributes

• The successful candidate will read, write, and speak fluent English, possess excellent communication skills, and will be capable of articulating the Company’s clinical and regulatory strategies and progress to the Senior Management Team.
• Must have the ability and strong desire to be “hands-on.” with a positive, can-do attitude.
• Availability to participate in early or late meetings/teleconferences.
• Ability and strong desire to work in a dynamic “start-up” environment and be able to travel domestically and/or internationally.
• Excellent interpersonal and influencing skills. This includes a demonstrated ability to use an open and supportive communication style and to work cross-functionally with multiple corporate sites, teams, and personalities.
• The ability to think strategically as well as execute project details.
• Performs other duties as required.

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Purpose of Role:

This position reports to the Vice President of pharmaceutical development. The associate research associate/scientist will contribute to the ongoing efforts to develop first-in-class or best-in-class therapies for metabolic and endocrine disorders. This is an excellent opportunity for a highly driven professional to contribute and grow value of a clinical-stage pharmaceutical company.

This is not a remote position and is onsite at the Viking San Diego office.

Key Tasks & Responsibilities:

• Work with the internal discovery team to advance discovery candidates to clinical development.
• Provide technical support including preclinical, analytical, formulation development and clinical manufacturing/packaging activities at CDMOs.
• Collaborate with other functions within Viking Therapeutics to develop and implement regulatory documents (e.g., specifications) for the development, manufacture, release and labeling of drug substance and clinical trial material (CTM).
• Manage external CROs for outsourced development activities.
• Draft and/or review nonclinical, and chemistry and manufacturing control (CMC) regulatory documents.
• Remain current in the field via relevant scientific literature.

Education:

• A BS/MS/PhD in analytical chemistry, organic chemistry, physical chemistry, pharmaceutical sciences, or related scientific field is required.

Professional Skills & Experience:

• 3+ years of related industry experience in a CMC environment including drug substance and/or drug product development, production, testing and release.
• Experience in a virtual biotech setting working with external CDMO and CRO based resources for preclinical activities, production of drug substance and drug product, testing, and CTM labeling is a plus.
• Experience and familiarity in the CMC regulatory environment for early to mid-stage development.
• Working knowledge and familiarity of GMP/ICH regulations required.
• Working knowledge of quality by design and risk management is a plus. Knowledge of ICH Q8/Q9 and Q10 is preferred.
• Team oriented professional with excellent organization, communication, leadership and problem-solving abilities.
• Demonstrate ability to successfully coordinate multiple work streams and development efforts in a timely and economically responsible manner in a small start-up biotech company.

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