Senior Medical Director, Asset/Therapeutic Area Lead

Senior Medical Director, Asset/Therapeutic Area Lead

Categories: Medical Affairs

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 Senior Medical Director, reporting to the Senior Vice President of Medical Affairs. This role will be instrumental in building and executing the Medical Affairs (MA) evidence generation, education, and KOL engagement assuring strategic alignment across multiple functional areas at Crinetics (commercial, compliance, legal, etc.). 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 drives 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 effectively respond to medical inquiries from customers and key stakeholders.

Essential Job Functions and Responsibilities

These may include but are not limited to:

• Implement the Medical Affairs strategic plans across products

• Provide thought leadership and tactical execution for medical publication planning, medical education, medical information system development, field medical liaisons, medical communication, RWE/HEOR

• Work closely with the clinical development and regulatory professionals as well as strategic alliance partners

• Build on established professional relationships with the Key Opinion Leader community and develop new relationships as appropriate to exchange scientific knowledge and identify current and future business opportunities, patients both for clinical trials and commercial planning

• Execute on MA strategic imperatives and tactical plans to enhance healthcare practitioner education and improve patient outcomes

• Focus on immediate and short-term (<2 years) strategic planning horizon

• Provide Medical expertise to the Commercial organization as needed to assist in the development and execution of compliant commercial activities

• Support preparation of clinical sections of relevant regulatory filings to Health Authorities

• Contribute to scientific affairs by authorizing and/or reviewing abstracts, presentations and manuscripts for medical accuracy and content and will have a strong understanding of all aspects of Crinetics products, related disease states and related products in the marketplace

• Develop strategy for review and approval of investigator-initiated studies

• In association with the HEOR Department, evaluate health economics landscape in each disease area 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 developing Senior Management approved launch plans

• Help to develop and lead KOL speaker programs on disease state, current therapeutics, and patient care gaps

• Work with clinical and commercial colleagues to develop and implement publication strategies across multiple programs

• Develop, refine, and implement Medical Affairs policies and procedures and SOPs Facilitate the conduct of scientific advisory boards and steering committees and partner with new product planning in executing subject matter expert focus groups

• Partner with various function in developing a CME strategy and implement process for review and approval

• Foster research relationships with key research centers in the US and OUS

• Interact regularly with key medical subject matter experts

• 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

• People leader responsibilities to include Medical Information and Publication team members. Lead, direct, manage, develop, coach and mentor, direct reports

• Provide complaint medical review of promotional materials

• Other duties as assigned

Education and Experience:

Required:

• Doctoral degree MD/DO (or equivalent), with pertinent clinical experience

• Board certified/board eligible

• 13+ years of medical affairs experience in pharmaceutical/biotech, preferably with hands-on involvement in NDA, BLA or MAA preparation, submission review, phase 4 post-marketing study planning and investigator-initiated studies

• 5+ years of proven successful, previous pharmaceuticals industry experience in a Medical Affairs leadership role

• 12+ 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

• 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 (MSL, CRM) and ARISg or Argus safety reporting systems

Preferred:

Preferred with 5+ years in a clinical or pharmaceutical/biotech setting with background in Medical Affairs with 2+ years in product development (endocrinology product development preferred)

Experience in endocrinology strongly preferred and preferably in rare disease

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Travel:

Travel may be required up to 30% of your time, and ability to travel globally as needed.

The Anticipated Base Salary Range: $275,000 - $345,000

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.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer:

Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws

Vaccination requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.