Clinical leader of one or more endocrinology programs, being integral to developing the clinical strategy and plans
Member of global project team(s) and development sub team(s)
Focus on immediate and short-term (<2 years) strategic planning horizon
Contribute as the Clinical Research expert to the conception and regular modifications of the Target Product Profile (TPP)
Lead the development of the Clinical Development Plan (CDP) for each indication being pursued
Conceive and write the Clinical Study Outline for each study in the CDP
Lead the discussions and oversee the writing of the study synopsis, study protocol and its amendments
Review or oversee the review on a regular basis the data input in the EDC for events of interest or needing further investigation and all reports generated from ongoing clinical studies
Provide senior‑level medical monitoring and safety oversight in cooperation with pharmacovigilance
Collaborate with other departments (Biometrics, Clinical Operations, Medical Affairs, a.o.) in all topics related to the conduct and analysis of clinical study results
Guide interpretation of clinical data
Use the findings and other analyses to contribute to trial-related advisory boards, lead investigator meetings, protocol training meetings
Support advisory boards, key opinion leader engagement, and external scientific collaborations
Contribute to the development of relevant sections of regulatory documents such as amendments to protocols, briefing books, safety updates, responses to Health Authorities questions

Requirements

MD degree with 10+ years in biopharmaceutical and/or pharma companies with 5+ years of clinical development spanning across Phase I–IV trials
A minimum of 10 years in a leadership role with 3-5 years of people management experience
Experience from clinical practice in internal medicine/endocrinology
Experience in designing, planning, and executing First-in-Human studies, Phase 2 proof-of concept studies and preferably also global phase 3 trials
Experience with application of biomarkers
Experience interacting with the FDA and/or EU regulatory agencies is a plus
Strong general knowledge of GCP, ICH guidelines and regulatory requirements and trial design that apply to clinical drug development
Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials required
Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment
Strong project planning, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems
Ability to work independently and collaboratively, prioritizing tasks efficiently and meeting clinical and corporate timelines
Strategic thinker, team leader and individual contributor capable of working in a high growth, dynamic, science-driven environment
Self-starter, who enjoys rolling up their sleeves and digging into the details
Able to conceive and execute innovative approaches to clinical development
Ability to inspire and earn respect of the leadership team, Board members, the investment community, colleagues, and staff.

Benefits

Health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
winter company shutdown
discretionary annual target bonus
stock options
ESPP
401k match

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical developmentclinical researchclinical study designmedical monitoringbiomarkersGCPICH guidelinesregulatory requirementsPhase I trialsPhase III trials

Soft Skills

leadershipproject planningnegotiationpresentationstrategic thinkingteam leadershipcollaborationproblem-solvingindependencecreativity

Certifications

MD degree