Sr. Medical Director, Carcinoid Syndrome Oncology Asset Lead

Crinetics PharmaceuticalsHeadquarters, KY
4d$270,000 - $301,000

About The Position

Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and robust pipeline across preclinical and clinical development. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Come join our team as we transform the lives of others. POSITION SUMMARY: Crinetics is seeking an innovative Medical Director, Asset Lead (Carcinoid Syndrome, Neuroendocrine Tumors (NETs)/Oncology) reporting to the Executive Director, Medical Affairs. This role will be instrumental in building and executing the Medical Affairs (MA) team’s evidence generation, education, and KOL engagement assuring strategic alignment across multiple functional areas at Crinetics (commercial, compliance, legal, etc.) within our Carcinoid Syndrome, NET, and Oncology indications. In collaboration with executive leadership, this individual will lead initiatives and deliver business results, set annual goals, develop and refine plans, policies and procedures while maintaining excellence in standards and practices. The individual will facilitate the collaboration with key opinion leaders and drive scientific engagement with health care practitioners, research groups, payers, and patient advocacy groups throughout the company. Must have the ability to maintain scientific credibility while being commercially supportive, to communicate scientific results, and to effectively respond to medical inquiries from customers and key stakeholders.

Requirements

  • Doctoral degree MD/DO, PhD, or PharmD (or equivalent), with pertinent Medical Affairs experience.
  • 13+ years of medical affairs experience in pharmaceutical/biotech, preferably, phase 4 post-marketing study planning.
  • 5+ years of proven successful, previous pharmaceuticals industry experience in a Medical Affairs leadership role.
  • 10 years in a supervisory/leadership role.
  • Proven experience building medical affairs infrastructure in a growing company preparing for it first new product launch.
  • Experience managing direct reports, building teams, and leveraging relationships with clinical and commercial teams.
  • Broad working knowledge of FDA requirements, industry compliance, clinical trial design and strategies, commercial and publication strategy, and medical information process.
  • Line management experience, particularly with mentoring and developing field-based employees.
  • Deep understanding of the underlying principles and practical application of health outcomes, quality standards, evidence-based medicine, disease management and related principles.
  • Excellent written, communication and interpersonal skills and proven success working in a multi-functional team-based environment.
  • Must be able to thrive in a dynamic, small, growth company environment.
  • Exercises judgment within generally defined practices and policies.
  • Effective presentation skills to key stakeholders and key decision makers.
  • Ability to work collaboratively across the organization to achieve corporate objectives is essential.
  • Excellent team management skills, ability to lead, train and mentor team members at all levels.
  • Ability to set and follow through goals with a sense of urgency while keeping broader strategic objectives in focus.
  • A hands-on approach to performing duties with a strong self-directed work ethic and attention to detail.
  • Collaborative attitude and ability to motivate and influence others without relying on position or power.
  • Strong organizational and time management skills in order to balance working on multiple projects in parallel.
  • Must understand and respect company core values and possess the highest integrity.
  • Knowledge of software preferred: Veeva (Promomats, MedComm, MSL, CRM) and ARISg or Argus safety reporting systems.

Nice To Haves

  • Preferred with 5+ years in a clinical or pharmaceutical/biotech setting with background in Medical Affairs with 2+ years in product development (oncology product development preferred).
  • Experience in oncology strongly preferred and preferably in oncology rare disease.

Responsibilities

  • Co-develop and implement the Medical Affairs strategic and integrated medical plans across their lead asset.
  • Through cross-functional collaboration, identify data gaps and develop and deliver an integrated evidence generation plan.
  • Provide scientific guidance and tactical execution for medical publication planning, medical education, medical information system development, field medical liaisons, medical communication, RWE, and HEOR
  • Work closely with clinical development and regulatory professionals as well as strategic alliance partners.
  • Develop and maintain professional relationships with Key Opinion Leaders (physicians and researchers) and relevant professional societies to exchange scientific knowledge and to identify current and future collaboration opportunities.
  • Contribute to the conduct of scientific advisory boards and steering committees and partner with new product planning in executing subject matter expert focus groups in concert with Executive Director, Medical Affairs.
  • Execute on MA strategic imperatives and tactical plans to enhance healthcare practitioner education and improve patient outcomes.
  • Support preparation of clinical sections of relevant regulatory filings to Health Authorities and safety reporting in conjunction with the Executive Medical Director, Medical Affairs.
  • Provide medical review of training materials for medical and commercial employees; contribute to scientific affairs by authorizing and/or reviewing abstracts, presentations and manuscripts for medical and scientific accuracy and content.
  • Work across the organization to develop and implement publication strategies across multiple programs.
  • Evaluate health economics landscape in each disease area in association with HEOR and make recommendations to the outcomes research plan that can support reimbursement and commercial activity.
  • Work closely with commercial and clinical development in writing target product profiles in light of potential life cycle management opportunities
  • Partner with Marketing, Market Access, and Commercial Operations in concert with the Executive Director, Medical Affairs, in developing Senior Management approved brand plans.
  • Develop, refine, and implement Medical Affairs policies and procedures and SOPs.
  • Partner with various functions in developing an IME/CME strategy and implement process for review and approval; provide medical review of applications for independent medical education grants.
  • Foster research relationships with key research centers in the US and OUS.
  • Interact regularly with key medical subject matter experts along with Executive Director, Medical Affairs.
  • Support the Medical Information function to respond to external requests for information regarding compounds in development and approved products consistent with promotional compliance and regulatory requirements.
  • Provide medical review or support the medical affairs review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations; partner effectively with commercial organization to develop scientifically rigorous promotional material.
  • Maintain up-to-date knowledge and adherence of all applicable guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function.
  • Other duties as assigned

Benefits

  • In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
  • We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

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What This Job Offers

Job Type

Full-time

Career Level

Executive

Education Level

Ph.D. or professional degree

Number of Employees

251-500 employees

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